Replication of the TECOS Diabetes Trial in Healthcare Claims
Conditions: Diabetes
Sponsor: Brigham and Women's Hospital

Eﬀect of Sitaglip/n on Cardiovascular Outcomes in Type 2 Diabetes 
(TECOS trial)
NCT03936062
December 27, 2019

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
1 
 
1. RCT Details 
This section provides a high-level overview of the RCT that the described real-world evidence study is trying to replicate as closely 
as possible given the remaining limitations inherent in the healthcare databases.  
 
1.1 Title 
Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes (TECOS trial) 
 
1.2 Intended aim(s) 
 
TECOS primarily tested the hypothesis that sitagliptin, when used as part of usual diabetes care, is non-inferior to usual care 
without sitagliptin with regard to the risk of significant confirmed cardiovascular outcomes. 
 
1.3 Primary endpoint for replication and RCT finding 
 
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina 
 
1.4 Required power for primary endpoint and noninferiority margin (if applicable) 
 
Power of 90% for the test of noninferiority (hazard ratio, 1.00). For superiority, 1,300 patients with a primary composite 
cardiovascular outcome would provide a power of approximately 81% to determine the superiority of sitagliptin over 
placebo (hazard ratio, 0.85). 
 
1.5 Primary trial estimate targeted for replication 
 
HR = 0.98 (95% CI, 0.88 - 1.09) comparing sitagliptin to placebo (Green et al., 2015) 
 
2. Person responsible for implementation of replication in Aetion 
Ajinkya Pawar, Ph.D. implemented the study design in the Aetion Evidence Platform. S/he is not responsible for the validity of the 
design and analytic choices. All implementation steps are recorded and the implementation history is archived in the platform.   
 
 
3. Data Source(s) 
United/Optum, MarketScan, Medicare  
 

!""#$%&'#(#))*+#)#,+$-*.&%-*/#,0*12+03*4,%,*%2*)5662+%*7489)*+#:50,%2+;*3#$&)&2(*<,=&(:]*L+2%2$20*?#<60,%#*
D
D#! 2)97<!'(-+35!'+*36*;!
?-#*)%53;*3#)&:(*3&,:+,<*'&)5,0&M#)*=#;*,)6#$%)*2"*%-#*02(:&%53&(,0*)%53;*3#)&:(*"2+*#S6#3&%#3*+#'&#.C*
*
!"#$%%&'"()*++'++&'"(),-".$,
/*0+)123456)57
8$9*#-*('):++'++&'"();-".$,
/*0+)123456)57
;*+<$=();-".$,
>?$)@-"*A%-B(-")$#)C". D'")EFG
/*0+)123456)237
!HI%=+-$")*++'++&'"(),-".$,)
>!J8@GK)@-9'#)8-##<$+-+6)88L)M 356)
N#'A"*"I0
/*0+)123456)57
L?8@
/*0+)12O36)57
8$<$#()!"(#0)/*(')>/*0)5G
1/-+B'"+*(-$")$P)E-(*A%-B(-")QR
C". D'"'#*(-$")E=%P$"0%=#'*)>EFG7
S-&'
!"#$%&'!$(%)(*'+ ,-./0',1234'1-542.3,2/6
T$%%$,)FB);-".$,
/*0+)136)I'"+$#*7
L?8@FELQ?)I#-('#-*),-".$,)>L?8@G
/-*A"$+-+)$P)SC/U
/*0+)123456)57
!J8@K /U)S0B'236)V'($*I-.$+-+6)E'9'#')W0B$A%0I'&-*
/*0+)12XYZ6)57
/*0)5
5127318'/9,./7-:0;<
!
!"#$%&'"%()*+%$,&%-
!
)!
!
.%+*/'
!
01.2(3"4%$5,'(0"6&"$
!J8@K)"##$%&'()*#$+'(
,-".(/01234(1256(
#&078&159063:
/*0+)12X36)57
L?8@K RH)P$#)U'(P$#&-"6)
N-$A%-(*[$"'6)EF)$#)
L"+=%-"
L?8@K MC)Q=(B*(-'"()9-+-(+6):A')M Z5)0#+)\)1UL6)NS8:6)8:]D6)
E('"(-"A6)L+I<'&-I)E(#$^'6)QII%=+-$")_)E('"$+-+)$P)8*#$(-.)
:#('#06)N'#-B<'#*%):#('#-*%)+('"(-"A)$#)#'9*+I=%*#-[*(-$"6)@$,'#)
'H(#'&-(0)*&B=(*(-$"7
/*0+)12XYZ6)57
('."&#=)$&%'>)$?")$(
!
7889++'"8'(*:(*9%8*;'
!
<'$%=
!
.%$+%(*:($>>&%&*"$,(?@#*49+'
!
?">(*:(&">'@('@#*49+'
!
<&4'"+*,,;'"%
!
.#'8&:&'>(<$%'(+'$8='>
!
.A&%8=(BA&%=&"(8*;#$+&4*"(6+#C
!
D9+4&"6(=*;'($>;&44&*"

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
3 
 
5. Cohort Identification  
 
5.1 Cohort Summary 
This study will involve a new user, parallel group, cohort study design comparing sitagliptin to the 2nd generation sulfonylurea 
(SU) antidiabetic class as a proxy for placebo. 2nd generation SUs are not known to have an impact on the outcome of interest. In 
addition, SUs were the most frequent background treatment in TECOS (after metformin), and both DPP4i and SUs are 
preferentially prescribed to similarly older patients in the real world (Patorno et al., 2019). The patients will be required to have 
continuous enrollment during the baseline period of 180 days before initiation of sitagliptin or a comparator drug (cohort entry 
date). Follow-up for the outcome (4P-MACE), begins the day after drug initiation. As in the trial, patients are allowed to take 
other antidiabetic medications during the study. 
 
5.2 Important steps for cohort formation 
 New users (defined as no use in 180 days prior to index date) of an exposure and a comparator drug will be identified. 
 
5.2.1 Eligible cohort entry dates 
Market availability of sitagliptin in the U.S. started on October 17, 2006.       
• For Marketscan: October 17, 2006-Dec 2017 (end of data availability).  
• For Medicare: Jan 1, 2012-Dec 31, 2017 (start- end of data availability). 
• For Optum: October 17, 2006-March 31, 2019 (end of data availability). 
 
5.2.2 Specify inclusion/exclusion criteria for cohort entry and define the index date 
 
Inclusion and exclusion criteria were adapted from the trial as closely as possible. Definitions for all inclusion/exclusion are provided 
in Appendix A and are summarized in the flowcharts below.   
 
5.3 Flowchart of the study cohort assembly 
 
 
Optum 
Marketscan 
Medicare* 

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
4 
  
Less 
Excluded 
Patients 
Remaining 
Patients 
Less 
Excluded 
Patients 
Remaining 
Patients 
Less 
Excluded 
Patients 
Remaining 
Patients 
All patients 
  
74,864,884 
  
191,990,035 
  
23,466,175 
Patients who used exposure or a reference between 17 Oct 2006 to Dec 
2017 (for Marketscan)/March 2019 (for Optum) and 01 January 2012-
December 2017 for Medicare 
-72908924 
1,955,960 
-
188954110 
3,035,925 
-19512001 
3,954,174 
Excluded due to insufficient enrollment 
-260546 
1,695,414 
-374862 
2,661,063 
-1094721 
2,859,453 
Excluded due to prior use of referent 
-1135398 
560,016 
-1658570 
1,002,493 
-1745525 
1,113,928 
Excluded due to prior use of exposure 
-237943 
322,073 
-531814 
470,679 
-511933 
601,995 
Excluded because patient qualified in >1 exposure category 
-1,240 
320,833 
-3,027 
467,652 
-1,510 
600,485 
Excluded based on Age 
-14 
320,819 
0 
467,652 
0 
600,485 
Excluded based on Gender 
-32 
320,787 
0 
467,652 
0 
600,485 
Excluded based on Inclusion 1- DM Type 2 with ICD-10 
-31605 
289,182 
-73914 
393,738 
-11767 
588,718 
Excluded based on Inclusion 1- Continuous use of Metformin, 
pioglitazone, or a sulfonylurea, or stable dose of insulin for past 3 
months 
-31597 
257,585 
-50189 
343,549 
-61901 
526,817 
Excluded based on Inclusion 2- At least 2 outpatient visits in prior 
year 
-533 
257,052 
-1,385 
342,164 
-412 
526,405 
Excluded based on Inclusion 3- Age >=50 AND History of a major 
clinical manifestation of coronary artery disease/Ischemic 
cerebrovascular disease 
-101729 
155,323 
-167085 
175,079 
-88675 
437,730 
Excluded based on Exclusion 1- history of type 1 diabetes mellitus 
or a history of ketoacidosis 
-3282 
152,041 
-3487 
171,592 
-9452 
428,278 
Excluded based on Exclusion 2- ≥2 hospitalizations for severe 
Hypoglycemia in prior year 
-21 
152,020 
-39 
171,553 
-318 
427,960 
Excluded based on Exclusion 3- DPP-4 i, GLP-1, or a 
thiazolidinedione other than pioglitazone within past 3 months 
-1711 
150,309 
-1979 
169,574 
-4416 
423,544 
Excluded based on Exclusion 4- Cirrhosis of liver 
-506 
149,803 
-316 
169,258 
-1,388 
422,156 
Excluded based on Exclusion 7-Pregnancy 
-8 
149,795 
-7 
169,251 
-13 
422,143 
Excluded based on Exclusion 8- CCI 180days >=10 
-2092 
147,703 
-1029 
168,222 
-10402 
411,741 
Final cohort 
  
147,703 
  
168,222 
  
411,741 
* Medicare database includes only patients ³65 years of age with at least one diagnosis for diabetes, heart failure, or stroke. 
 
6. Variables  
 
6.1 Exposure-related variables:  

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
5 
 
Study drug:  
The study exposure of interest is initiation of sitagliptin. Initiation will be defined by no use of sitagliptin or a comparator in the prior 
6 months before treatment initiation (washout period).  
 
Comparator agents: 
• Initiators of sitagliptin will be compared to initiators of- 
o 2nd generation sulfonylureas 
 
Because sitagliptin and comparators are frequently used as second or third line treatments of T2DM, we expect it to be unlikely that 
sitagliptin and comparators are initiated in patients with substantially different baseline risk for proposed outcomes.  
 
6.2 Preliminary covariates: 
• Age 
• Sex 
• Combined Comorbidity Index (CCI), measured over the default baseline covariate assessment period, defined as 180 days 
prior to and including index date 
 
Covariates listed above represent only a small subset of covariates that will ultimately be controlled for in the design and analysis. 
We use the covariates above only for initial feasibility analyses to judge whether there is likely to be sufficient overlap between 
treatment groups to proceed with the study. Remaining covariates are defined only after the study has passed the initial feasibility 
analysis and the initial power assessment and are listed in Table 1 (Appendix B). These covariates are based on those used by 
Patorno et al. (2019). 
 
6.3 Outcome variables and study follow-up:  
 
6.3.1 Outcome variables 
 
Primary Effectiveness outcomes of interest (definitions provided in Appendix A):  
 

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
6 
• Primary outcome: 4-point major adverse cardiovascular events (MACE), i.e., non-fatal myocardial infarction, non-fatal stroke, 
or CV mortality; as well as each individual component: 
• Secondary outcomes: Individual MACE components: 
o Hospital admission for MI (for purposes of this individual component, fatal MI is included) 
o Hospital admission for stroke (for purposes of this individual component, fatal stroke is included) 
o Hospital admission for ACS/unstable angina 
o All-cause mortality/CV mortality: 
§ All-cause inpatient mortality identified using discharge status codes will be used as a proxy for “CV mortality” 
in commercial databases 
§ Information on CV mortality through data linkage with the National Death Index (NDI) will only become 
available at a later date for Medicare and will be used in secondary analyses. 
 
Control outcomes of interest (control outcomes only serve to assess aspects of study validity but are not further interpreted):  
1. Severe hypoglycemia (we expect to see protective effect; American Diabetes Association, 2018) 
Control outcome definitions 
 
 
 
 
 
 
 
 
 
6.3.2 Study follow-up 
Both as-treated (AT) and intention-to-treat (ITT) analyses will be conducted with treatment defined as the index drug on the day of 
cohort entry. Because adherence in the real world databases is expected to be much worse than in the trial, the AT analysis is the 
primary analysis, as it targets the relative hazard of outcomes on treatment.  
 
Outcome 
Hospital Discharge Code(s) 
Comments 
Severe hypoglycemia 
Severe hypoglycemia 
Any-position ED or primary inpatient ICD-9 diagnosis: 251.0, 251.1x, 251.2x, or 250.8x.  
Outcomes identified by 250.8x are not included if they co-occur with one of the 
following diagnoses: 259.8, 272.7, 681.xx, 682.xx, 686.9, 707.1x, 707.2x, 707.8, 707.9, 
709.3, 730.0x, 730.1x, 730.2x, 731.8 
Note- The  corresponding ICD-10 
codes will  be used  also 

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
7 
For the AT analyses, the follow-up will start the day after initiation of liraglutide and comparator and will continue until the earliest 
date of the following events: 
• The first occurrence of the outcome of interest, unless otherwise specified for selected outcomes,  
• The date of end of continuous registration in the database, 
• End of the study period, 
• Measured death event occurs, 
• Nursing home admission 
o Nursing home admissions are considered a censoring event because the data sources utilized typically provide little to 
no data on a patient, particularly on drug utilization, after admission. We will utilize this as an exclusion reason for 
cohorts for the same reason. 
• The date of drug discontinuation, defined as the date of the last continuous treatment episode of the index drug (sitagliptin 
and comparator) plus a defined grace period (i.e., 30 days after the end of the last prescription’s days’ supply in main 
analyses). 
•  The date of augmentation or switching from an exposure to a comparator or any other agent in the comparator class and 
vice versa (e.g. switching from glimepiride to glipizide would be a censoring event); 
o A dosage change on the index treatment does not fulfill this criterion 
o An added treatment that is not part of the exposure or comparator group does not fulfill this criterion (e.g. if a 
sitagliptin user adds insulin, he or she does not get censored at the time of insulin augmentation) 
 
For the ITT analyses, the censoring based on the augmentation/switching and treatment discontinuation will be replaced with a 
maximum allowed follow-up time of 365 days.  
 
7. Initial Feasibility Analysis  
 
Aetion report links: 
Optum: https://bwh-dope.aetion.com/#/projects/details/640/results/26047/result/0  
Marketscan: https://bwh-dope.aetion.com/#/projects/details/638/results/26040/result/0 
Medicare: https://bwh-dope.aetion.com/#/projects/details/639/results/26043/result/0 
 
Date conducted: Sep 30, 2018 
 

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
8 
Complete Aetion feasibility analysis using age, sex, and CCI as the only covariates and the primary endpoint (Section 6.3.1) as the 
outcome. No measures of association will be computed nor will incidence rates stratified by treatment group.  
• Report patient characteristics by treatment group 
• Report summary parameters of study population 
• Report median follow-up time by treatment group 
• Report reasons for censoring in the overall study population 
 
 
8. Initial Power Assessment 
 
Aetion report links: 
Optum: https://bwh-dope.aetion.com/#/projects/details/640/results/26049/result/0 
Marketscan: https://bwh-dope.aetion.com/#/projects/details/638/results/26050/result/0 
Medicare: https://bwh-dope.aetion.com/#/projects/details/639/results/26051/result/0 
 
Date conducted: Sep 30, 2018 
 
In order to complete the initial power analysis, the dummy outcome of a 90-day gap in database enrollment will be used. This 
outcome is used to ensure that no information on the comparative risks of the outcomes of interest are available at this stage. 
Complete a 1:1 PS-matched comparative analysis using this outcome. PS should include only 3 covariates: age, sex, and combined 
comorbidity index. Power calculations are based on the formulas from Chow et al. (2008). 
 
• Stop analyses until feasibility and power are reviewed by primary investigators and FDA. Reviewers evaluate the results of the 
analyses described above in Sections 7 and 8, including numbers of patients, patient characteristics, follow-up time, and reasons 
for censoring by treatment group, as well as overall rates of outcomes and study power. These parameters are re-evaluated in the 
subsequent sections, after incorporating feedback and refining the protocol. 
Reviewed by PI: 
Jessica M. Franklin 
Date reviewed: 
10/26/18 
Reviewed by FDA: 
Ken Quinto 
Date reviewed: 
12/11/18 
Reasons for stopping 
analysis (if required): 
 
 

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
9 
 
9. Balance Assessment after PS matching 
 
Aetion report links (Sitagliptin vs. 2nd generation SUs): 
Optum: https://bwh-dope.aetion.com/projects/details/640/results/44780/result/0 
Marketscan: https://bwh-dope.aetion.com/projects/details/638/results/44781/result/0 
Medicare: https://bwh-dope.aetion.com/projects/details/639/results/45413/result/0 
 
Date conducted: 11/18/2019 (Medicare 11/30/2019) 
 
After review of initial feasibility and power analyses, complete creation of the remaining covariates (see Table 1 below for list of 
covariates). Again, using the dummy outcome of a 90-day gap in database enrollment, complete a 1:1 PS-matched analysis. The PS 
should include the complete list of covariates (excluding laboratory values, which are missing in some patients). 
 
• Provide plot of PS distributions stratified by treatment group. 
 
Note- Please refer to Appendix B.  
 
• Report covariate balance after matching. 
 
Note- For Table 1, please refer to Appendix B.  
 
• Report reasons for censoring by treatment group. 
  
Overall 
Referent 
Exposure 
Dummy Outcome 
0 (0.00%) 
0 (0.00%) 
0 (0.00%) 
Death 
7,596 (2.17%) 
4,072 (2.33%) 
3,524 (2.02%) 
Start of an additional exposure 
22,929 (6.56%) 
6,881 (3.94%) 
16,048 (9.18%) 
End of index exposure 
210,496 (60.23%) 
104,902 (60.03%) 
105,594 (60.43%) 
Specified date reached 
36,338 (10.40%) 
19,668 (11.26%) 
16,670 (9.54%) 
End of patient enrollment 
33,356 (9.54%) 
17,150 (9.81%) 
16,206 (9.27%) 
Switch to other SUs (for censoring) + nursing home admission 
38,761 (11.09%) 
22,065 (12.63%) 
16,696 (9.55%) 

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
10 
 
• Report follow-up time by treatment group. 
 
Median Follow-Up Time (Days) [IQR]  
Patient Group 
Optum 
Marketscan 
Medicare 
Overall Patient Population 
118 [58-270] 
120 [58-300] 
118 [58-297] 
Referent 
118 [58-295] 
121 [58-316] 
121 [58-316] 
Exposure 
118 [58-246] 
118 [58-279] 
118 [58-279] 
 
• Report overall risk of the primary outcome. 
  
Optum 
Marketscan 
Medicare 
Risk per 1,000 patients 
29.17 
37.73 
62.67 
 
10. Final Power Assessment 
 
Date conducted:  
 
• Re-calculate power in the appropriate excel table, using the revised number of matched patients from the PS-match in Section 9. 
All other parameters in the table should be the same as in Section 8. If the study is to be implemented in more than one 
database, copy and paste excel sheet to report power for each database separately and for the pooled analysis that uses data 
from all databases together. Power calculations are based on the formulas from Chow et al. (2008). 
 
o Pooled 

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
11 
 
 
o Optum 
 
 
o Marketscan 
Non-inferiority Analysis
Number of patients matched
Reference
174,738
Exposed
174,738
Risk per 1,000 patients
43.19
Assumed HR from RCT
1
Alpha (2-sided)
0.05
Non-inferiority margin
1.3
Number of events expected
15093.86844
Power
1
Superiority Analysis
Number of patients matched
Reference
174,738
Exposed
174,738
Risk per 1,000 patients
43.19
Desired HR from RCT
0.85
Alpha (2-sided)
0.05
Number of events expected
15093.86844
Power
1
Non-inferiority Analysis
Number of patients matched
Reference
29,727
Exposed
29,727
Risk per 1,000 patients
29.17
Assumed HR from RCT
1
Alpha (2-sided)
0.05
Non-inferiority margin
1.3
Number of events expected
1734.27318
Power
0.999770031
Superiority Analysis
Number of patients matched
Reference
29,727
Exposed
29,727
Risk per 1,000 patients
29.17
Desired HR from RCT
0.85
Alpha (2-sided)
0.05
Number of events expected
1734.27318
Power
0.92278468

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
12 
 
 
o Medicare 
 
 
• Stop analyses until balance and final power assessment are reviewed by primary investigators, FDA, and assigned members of 
Non-inferiority Analysis
Number of patients matched
Reference
42,600
Exposed
42,600
Risk per 1,000 patients
37.73
Assumed HR from RCT
1
Alpha (2-sided)
0.05
Non-inferiority margin
1.3
Number of events expected
3214.596
Power
0.999999978
Superiority Analysis
Number of patients matched
Reference
42,600
Exposed
42,600
Risk per 1,000 patients
37.73
Desired HR from RCT
0.85
Alpha (2-sided)
0.05
Number of events expected
3214.596
Power
0.995942377
Non-inferiority Analysis
Number of patients matched
Reference
102,411
Exposed
102,411
Risk per 1,000 patients
62.67
Assumed HR from RCT
1
Alpha (2-sided)
0.05
Non-inferiority margin
1.3
Number of events expected
12836.19474
Power
1
Superiority Analysis
Number of patients matched
Reference
102,411
Exposed
102,411
Risk per 1,000 patients
62.67
Desired HR from RCT
0.85
Alpha (2-sided)
0.05
Number of events expected
12836.19474
Power
1

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
13 
advisory board. Reviewers evaluate the results of the analyses described above in Sections 9 and 10, including numbers of 
patients, balance in patient characteristics, follow-up time, and reasons for censoring by treatment group, as well as overall rates 
of outcomes and study power. 
Reviewed by PI: 
Jessica Franklin 
Date reviewed: 
12/9/19 
Reviewed by FDA: 
Ken Quinto 
Date reviewed: 
12/20/19 
Reasons for stopping 
analysis (if required): 
 
 
11. Study Confidence and Concerns 
 
Deadline for voting on study confidence and listing concerns: 12/20/19 
 
• If final feasibility and power analyses are reviewed and approved, proceed to the remaining protocol steps. 
• All study team and advisory board members that review this protocol should at this stage provide their level of confidence for the 
success of the RWD study in the Google Form. This form also provides space for reviewers to list any concerns that they feel may 
contribute to a failure to replicate the findings of the RCT, including differences in study populations, poor measurement of study 
variables, or residual confounding. All responses will be kept confidential and individual-level results will only be shared with the 
individual respondent. 
 
12. Register study protocol on clinicalTrials.gov 
 
Date conducted:    
 
• Register the study on clinicalTrials.gov and upload this document. 
 
13. Comparative Analyses 
 
Aetion report name: 
Date conducted:    
 
13.1 
For primary analysis:  

Effectiveness research with Real World Data to support FDA’s regulatory decision making: Protocol Template 
 
14 
 
• In the PS-matched cohort from Section 9, calculate the HR for each outcome for sitagliptin versus 2nd generation SU patients 
using a Cox proportional hazards model.  
 
13.2 
For secondary analyses: 
• In both pre-matched cohorts, perform asymmetrical trimming to remove patients with PS values below the 2.5th percentile of 
treated patients and above the 97.5th percentile of untreated patients. In the trimmed cohort, calculate the HR for canagliflozin 
versus referent patients using a Cox proportional hazards model, adjusting for deciles of the PS. 
 
 
14.  Requested Results  
 
14.1 
Results from primary and secondary analyses; 
 
Analysis 
No. exposed events 
No. referent events 
Exposed rate 
Referent rate 
HR (95% CI) 
Crude 
 
 
 
 
 
Primary analysis 
 
 
 
 
 
Analysis 2 
 
 
 
 
 
... 
 
 
 
 
 
HR, Hazard Ratio; CI, Confidence Interval. 
 
15. References 
 
American Diabetes Association. 8. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2018. 
Diabetes Care. 2018;41(Suppl 1):S73-S85. doi:10.2337/dc18-S008. 
 
Chow S, Shao J, Wang H. 2008.  Sample Size Calculations in Clinical Research. 2nd Ed. Chapman & Hall/CRC Biostatistics Series. page 
177 
 
Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM. Effect of sitagliptin on 
cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine. 2015; 373(3):232-42. 

Effectiveness research with Real World Data to support FDA’s regulatory decision making 
 
 
15 
 
Patorno E, Pawar A, Franklin JM, et al. Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care: A First 
Analysis from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study. Circulation. 2019; in press. 
(https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.118.039177)  
  
 

#  
TECOS trial definitions 
Implementation in routine care
Reference/Rationale
Color coding
Sitagliptin versus placebo
Sitagliptin vs. 2nd generation sulfonylureas
Criteria
Adequate mapping in claims
The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, 
nonfatal stroke, or hospitalization for unstable angina. HR  0.98; 95% CI, 0.88 to 1.09; P<0.001
Measured 1 days after drug initiation in diagnosis position specified below and inpatient care 
setting:
Inpatient mortality/MI/Stroke/Angina --
For ACS/unstable angina
Any diagnosis position in inpatient care setting
Discharge diagnosis ICD-9 411.xx
For MI
Any diagnosis position in inpatient care setting
ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care)
For stroke
Primary diagnosis position in inpatient care setting 
ICD-9 discharge diagnosis:
430.xx  Subarachnoid hemorrhage (SAH)
431.xx  Intracerebral hemorrhage (ICH)
433.x1  Occlusion and stenosis of precerebral arteries with cerebral infarction
434.xx (excluding 434.x0)  Occlusion and stenosis of cerebral arteries with cerebral infarction
436.x  Acute, but ill-defined cerebrovascular events
Mortality- See Mortality Sheet.
For MI: 
PPV 94% in Medicare claims data [Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio 
CC, Avorn J, Solomon DH. Accuracy of Medicare claims-based diagnosis of acute 
myocardial infarction: estimating positive predictive value on the basis of review 
of hospital records. American heart journal 2004;148:99-104.]
PPV 88.4% in commercially-insured population [Wahl PM, Rodgers K, 
Schneeweiss S, et al. Validation of claims-based diagnostic and procedure codes 
for cardiovascular and gastrointestinal serious adverse events in a commercially-
insured population. Pharmacoepidemiology and Drug Safety 2010;19:596-603.]
For stroke:
PPV of 85% or higher for ischemic stroke
PPV ranging from 80% to 98% for hemorrhagic stroke
[Andrade SE, Harrold LR, Tjia J, et al. A systematic review of validated methods 
for identifying cerebrovascular accident or transient ischemic attack using 
administrative data. Pharmacoepidemiology and Drug Safety 2012;21 Suppl 
1:100-28.]
[Tirschwell DL, Longstreth WT, Jr. Validating administrative data in stroke 
research. Stroke; a journal of cerebral circulation 2002;33:2465-70.]
[Roumie CL, Mitchel E, Gideon PS, Varas-Lorenzo C, Castellsague J, Griffin MR. 
Validation of ICD-9 codes with a high positive predictive value for incident 
strokes resulting in hospitalization using Medicaid health data. 
Pharmacoepidemiology and drug safety 2008;17:20-6.]
Intermediate mapping in claims
Poor mapping or cannot be measured in claims 
Patient has T2DM with HbA1c of ≥6.5% (48 mmol/mol) and ≤8.0% (64 mmol/mol). HbA1c must be documented 
within 3 months prior to study enrollment, while receiving either:
Measured 180 days prior to drug initiation any diagnosis position in inpatient or outpatient 
care settings:
Patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) 
in the 180 days prior to drug initiation in any diagnosis position and inpatient or outpatient 
care setting 
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
Can't be measured in claims but not important for the 
analysis
• Metformin, pioglitazone, or a sulfonylurea as monotherapy or any dual combination of metformin, pioglitazone, 
or a sulfonylurea continuously without alteration in dose for at least 3 months. Note: patients who have received 
insulin for only a short period (i.e. less than 14 days) during a hospitalization or for the management of acute illness 
will not be excluded for that reason.
Measured 91 days prior to drug initiation as any dispensing  of one of the following drugs:
Metformin, pioglitazone, or a sulfonylurea (monotherapy or any dual combination)   
• A stable dose of insulin (±20% of the scheduled total daily insulin dose) either alone or in combination with a 
stable  dose of metformin for at least 3 months. The use of supplemental/sliding scale insulin during the prior 3 
months is permissible, as long as the total daily insulin dose is within ±20% of the scheduled total daily insulin 
dose. Note: Patients who have required modification of their usual daily insulin dose for a short period (b14 days) 
during a hospitalization or  for the management of acute illness will not be excluded for that reason.
Measured 91 days prior to drug initiation as any dispensing  of insulin (Please see AHA therapies 
sheet for full definition).
2
Patient is able to see a usual care provider at least twice per year.
Measured 365 days prior to drug initiation as any 2 claims in outpatient care setting
3 Patient is ≥50 years of age with pre-existing vascular disease, defined as having any one of the following:
Patient is ≥50 years of age measured on day of drug initiation
Please see the following Google Drive for further details or any missing information: 
https://drive.google.com/open?id=1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV
ICD-10 codes are not listed in this document because of excel cell size limitations and excessive number of ICD-10 codes. Full ICD-10 
code lists will be available in the above Google Drive Folder (link above). ICD-9 to ICD-10 code conversions were completed using a SAS 
macro that implements forward/ backward mapping based on the CMS ICD-9 to ICD-10 mapping:
 https://www.nber.org/data/icd9-icd-10-cm-and-pcs-crosswalk-general-equivalence-mapping.html
1
PRIMARY OUTCOME
Trial details- 2b- Failed S with NI- No label change
EXPOSURE vs. COMPARISON
INCLUSION CRITERIA
Appendix A

3a
• History of a major clinical manifestation of coronary artery disease (i.e., MI, surgical or percutaneous [balloon 
and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥50% in 
a major  epicardial artery or branch vessel);
Measured 365 days prior to drug initiation in  any diagnosis/procedure position and care 
setting defined below:
Inpatient or outpatient Acute MI: 410.xx, Inpatient or outpatient Old MI: 412.xx
Also include 414.xx (Inpatient or outpatient)
PTCA:
Inpatient CPT-4: 92973, 92982, 92984, 92995, 92996, 92920 – 92921, 92924 – 92925, 
92937, 92938, 92941, 92943, 92944
OR –
Inpatient or outpatient ICD-9 procedure: 00.66, 36.01, 36.02, 36.03, 36.05, 36.09
Stenting:
Inpatient CPT-4:  92980, 92981, 92928 – 92929, 92933 - 92934
OR –
Inpatient or outpatient  ICD-9 procedure: 36.06, 36.07
CABG:
Inpatient CPT-4: 33510 – 33536, 33545, 33572. 
       OR – 
Inpatient or outpatient ICD-9 procedure: 36.1x, 36.2x
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
3b
• Ischemic cerebrovascular disease, including:
◦ History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
Measured 365 days prior to drug initiation in any diagnosis position and inpatient or 
outpatient care setting:
Ischemic stroke (w and w/o mention of cerebral infarction)- 433.xx, 434.xx, 436.xx
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
◦ History of carotid arterial disease as documented by ≥50% stenosis documented by carotid ultrasound, magnetic 
resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
Measured 365 days prior to drug initiation in any diagnosis position and inpatient or 
outpatient care setting:
Occlusion and stenosis of carotid artery without mention of cerebral infarction
433.10
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
• Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to 
vascular  disease, current symptoms of intermittent claudication confirmed by an ankle brachial pressure index or 
toe brachial  pressure index less than 0.9, or history of surgical or percutaneous revascularization procedure.
Measured 365 days prior to drug initiation in any diagnosis/procedure position and inpatient 
or outpatient care setting:
Peripheral arterial stenting or surgical revascularization 
ICD-9 39.25, 39.50, 39.99. 
Lower extremity amputation  
ICD-9 diagnosis: V49.7x 
ICD-9 procedure: 84.10-84.18
CPT: 27590, 27591, 27592, 27880, 27881, 27882, 27884, 27886, 27888, 27889, 28800, 
28805, 28810, 28820, 28825
Ankle brachial pressure index <0.9
ICD-9 440.21
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
4 Female patients agree to use an effective method of contraception or must not otherwise be at risk of becoming 
pregnant.
Since this is an inclusion criteria, it's difficult to implement the contraceptive use requirement 
here, but we have pregnancy as an exclusion criteria later, so this requirement is implemented 
then.
5 Patient understands the study procedures, alternative treatments available, and the risks involved with the study, 
and voluntarily agrees to participate by providing written informed consent.
N/A
6 Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment 
during the follow-up period.
N/A
1 Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
Measured 180 days prior to drug initiation in any diagnosis position and inpatient or 
outpatient care setting:
DM type 1- At least 1 inpatient or outpatient ICD-9 Dx code of 250.x1 or 250.x3 or ICD-10 Dx 
code of E10.x in the 6 months prior to drug initiation. 
Ketoacidosis
250.1x
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
EXCLUSION CRITERIA
Appendix A

2
Patient has a history of ≥2 episodes of severe hypoglycemia during the 12 months prior to enrollment. Severe 
hypoglycemia (hypoglycemia requiring assistance) refers to instances in which the patient was sufficiently 
disoriented or incapacitated as to require help from another individual or from medical personnel (whether or not 
this assistance was actually provided).
Measured 365 days prior to drug initiation in any diagnosis position and inpatient care setting:  
251.1x, 251.20, 962.30 
Also, 250.8x as long as none of the following codes are co-occurring diagnoses (i.e. same day):  
259.8, 272.7,681.xx, 682.xx, 686.9x , 707.xx , 709.3, 730.0-730.2, 731.8 
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
3
Patient has taken an approved or investigational DPP-4 inhibitor agent (eg, sitagliptin, alogliptin, saxagliptin, or 
vildagliptin), GLP-1 analogues (eg, exenatide, exenatide LAR, or liraglutide), or a thiazolidinedione other than 
pioglitazone  within the past 3 months.
Measured 91 days prior to drug initiation as a dispensing of one of the following drugs:  DDP-4, 
GLP-1, or a thiazolidinedione (other than pioglitazone). Please see full definition in the AHA 
therapies sheet.
4 Patient has cirrhosis of the liver, as assessed by medical history.
Measured 180 days prior to drug initiation in any diagnosis position and inpatient or 
outpatient care setting: 
Liver cirrhosis- 571.2, 571.5, 571.6
Karagozian R et al. "Obesity paradox in advanced liver disease: obesity is 
associated with lower mortality in hospitalized patients with cirrhosis." Liver int. 
2016 Oct; 1450-6. doi: 10.1111/liv.13137. Epub 2016 May 4.
5 Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or 
an intervention that would interfere with the conduct of the trial.
N/A
6 Patient has a planned or anticipated revascularization procedure.
N/A
7 Pregnancy or planned pregnancy during the trial period.
Measured 180 days prior to drug initiation in any diagnosis/procedure position and inpatient 
or outpatient care setting:
Refer to Pregnancy sheet.
Patorno, Elisabetta et al. "Cardiovascular outcomes associated with canagliflozin 
versus other non-gliflozin antidiabetic drugs: population based cohort study." 
BMJ 2018;360:k119 http://dx.doi.org/10.1136/bmj.k119
Patorno, Elisabetta et al. "Empagliflozin and the Risk of Heart Failure 
Hospitalization in Routine Clinical Care: A First Analysis from the Empagliflozin 
Comparative Effectiveness and Safety (EMPRISE) Study."  Circulation. 2019 Apr 8. 
doi: 10.1161/CIRCULATIONAHA.118.039177
8 Patient has medical history that indicates a life expectancy of <2 years or might limit the individual’s ability to take 
trial treatments for the duration of the study.
Measured 180 days prior to drug initiation:
Exclude patients with a combined comorbidity score >=10
Gagne, Josh J et. al. "A combined comorbidity score predicted mortality in 
elderly patients better than existing scores." J Clin Epidemiol. 2011 Jul;64(7):749-
59. doi: 10.1016/j.jclinepi.2010.10.004.
Sun, Jenny W et. al. "Validation of the Combined Comorbidity Index of Charlson 
and Elixhauser to Predict 30-Day Mortality Across ICD-9 and ICD-10." Med Care. 
2018 Sep;56(9):812. doi: 10.1097/MLR.0000000000000954.
9
Patient has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance which, 
in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the 
patient’s best interest, confound the results of the study (eg, if patient cannot comply with requirements of the 
study), or interfere with the patient’s participation for the full duration of the study.
N/A
10 Patient has an estimated GFR (calculated based on serum creatinine via the MDRD formula) of b30 mL/ min per 
1.73 m2.
N/A
11 Patient has a known allergy or intolerance to sitagliptin.
N/A
12 Patient has previously been enrolled in the trial.
N/A
Appendix A

Trial ID 
Trial Name (with web links)
TECOS
Trial Name (with pdf links)
NCT
NCT00790205
Trial category
Therapeutic Area
Endocrinology
RCT Category  
2b- Failed S with NI- No label change
Brand Name
Generic Name
Sitagliptin
Sponsor
Merck Sharp & Dohme Corp.
Year
2015
Measurable endpoint
Composite of cardiovascular death, nonfatal myocardial 
infarction, nonfatal stroke, or hospitalization for unstable 
angina
Exposure
Sitagliptin
Comparator
Placebo
Population
Trial finding
HR  0.98; 95% CI, 0.88 to 1.09; P<0.001
Notes
No. of Patients
Non-inferiority margin
HR = 1.30
Assay Sens. Endpoint
Assay Sens. Finding
Ajinkya comments
Power
power of approximately 81% to determine the 
superiority of sitagliptin over placebo (hazard ratio, 0.85)
Blinding
Statistical Method
Approval indication
Appendix A

Mortality- Dependent on data source. 
1. All-cause mortality / inpatient mortality
Identified using the vital status file-
Medicare
Identified using the discharge status codes-
Optum-
• 20 = EXPIRED
• 21 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 22 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 23 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 24 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 25 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 26 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 27 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 28 = EXPIRED TO BE DEFINED AT STATE LEVEL
• 29 = EXPIRED TO BE DEFINED AT STATE LEVEL       
• 40 = EXPIRED AT HOME (HOSPICE)
• 41 = EXPIRED IN A MEDICAL FACILITY (HOSPICE)
• 42 = EXPIRED - PLACE UNKNOWN (HOSPICE)
Truven-       
• 20 - Died
• 22 - Died
• 23 - Died
• 24 - Died
• 25 - Died
• 26 - Died
• 27 - Died
• 28 - Died
• 29 - Died
• 40 - Other died status or Expired at home (Hospice claims only) (depends on year)
• 41 - Other died status or Expired in medical facility (Hospice claims only) (depends on year)
Appendix A

• 42 - Other died status or Expired - place unknown (Hospice claims only) (depends on year)
• 21 - Died or Disch./Transf. to court/law enforcement (depends on year)
2. CV mortality
Information on CV mortality through data linkage with the National Death Index (NDI) will be 
available for Medicare and Optum Clinformatics at a later date. We will conduct secondary analyses 
using CV mortality at that time.
Appendix A

Antidiabetic class
Specific agent
Notes
Canagliflozin
Approved 3/29/2013
Dapagliflozin
Empagliflozin
Ertugliflozin
Approved Dec 21, 2017
Glimepiride
Glipizide
Glyburide 
Alogliptin
Linagliptin
Saxagliptin
Sitagliptin
Exenatide
Liraglutide
Albiglutide
Approved April 15, 2014 and 
discontinued July 26, 2017
Dulaglutide
Approved Sep 18, 2014
Lixisenatide
Approved July 28, 2016
Semaglutide
Approved Dec 5, 2017
Insulin Aspart
Insulin Aspart/Insulin Aspart Protamine
Insulin Degludec
Insulin Detemir
Insulin Glargine
Insulin Glulisine
Insulin human isophane (NPH)
Insulin human regular (search with NPH, 
don't want bf-pk)
Insulin human regular/ Insulin human 
isophane (NPH)
Insulin Lispro
Insulin Lispro/Insulin Lispro Protamine
Pioglitazone
SGLT2-inhibitors
2nd generation sulfonylureas
DPP-4 inhibitors
GLP-1 receptor agonist (GLP1-RA)
Insulin
Glitazones
Appendix A

Rosiglitazone
Nateglinide
Repaglinide
Acarbose
Miglitol
Pramlintide
Pramlintide
Acetohexamide
Chlorpropamide
Tolazamide 
Tolbutamide
Meglitinides
Alpha-glucosidase inhibitors
1st generation sulfonylureas
Glitazones
Appendix A

Pregnancy 
Dx codes 
650   NORMAL DELIVERY
660   OBSTRUCTED LABOR
661   ABNORMALITY OF FORCES OF LABOR
662   LONG LABOR
663   UMBILICAL CORD COMPLICATIONS DURING LABOR AND DELIVERY
664   TRAUMA TO PERINEUM AND VULVA DURING DELIVERY
665   OTHER OBSTETRICAL TRAUMA
667   RETAINED PLACENTA OR MEMBRANES WITHOUT HEMORRHAGE
668   COMPLICATIONS OF THE ADMINISTRATION OF ANESTHETIC OR OTHER SEDATION IN LABOR AND DELIVERY
669.94   UNSPECIFIED COMPLICATION OF LABOR AND DELIVERY POSTPARTUM CONDITION OR COMPLICATION
V24   POSTPARTUM CARE AND EXAMINATION
V24.0   POSTPARTUM CARE AND EXAMINATION IMMEDIATELY AFTER DELIVERY
V24.1   POSTPARTUM CARE AND EXAMINATION OF LACTATING MOTHER
V24.2   ROUTINE POSTPARTUM FOLLOW
V27   OUTCOME OF DELIVERY
V27.0   MOTHER WITH SINGLE LIVEBORN
V27.1   MOTHER WITH SINGLE STILLBORN
V27.2   MOTHER WITH TWINS BOTH LIVEBORN
V27.3   MOTHER WITH TWINS ONE LIVEBORN AND ONE STILLBORN
V27.4   MOTHER WITH TWINS BOTH STILLBORN
V27.5   MOTHER WITH OTHER MULTIPLE BIRTH ALL LIVEBORN
V27.6   MOTHER WITH OTHER MULTIPLE BIRTH SOME LIVEBORN
V27.7   MOTHER WITH OTHER MULTIPLE BIRTH ALL STILLBORN
V27.9   MOTHER WITH UNSPECIFIED OUTCOME OF DELIVERY
Procedure codes 
72.0   LOW FORCEPS OPERATION
72.1   LOW FORCEPS OPERATION WITH EPISIOTOMY
72.2   MID FORCEPS OPERATION
72.21   MID FORCEPS OPERATION WITH EPISIOTOMY
72.29   OTHER MID FORCEPS OPERATION
72.3   HIGH FORCEPS OPERATION
72.31   HIGH FORCEPS OPERATION WITH EPISIOTOMY
72.39   OTHER HIGH FORCEPS OPERATION
Appendix A

72.4   FORCEPS ROTATION OF FETAL HEAD
72.5   BREECH EXTRACTION
72.51   PARTIAL BREECH EXTRACTION WITH FORCEPS TO AFTERCOMING HEAD
72.52   OTHER PARTIAL BREECH EXTRACTION
72.53   TOTAL BREECH EXTRACTION WITH FORCEPS TO AFTERCOMING HEAD
72.54   OTHER TOTAL BREECH EXTRACTION
72.6   FORCEPS APPLICATION TO AFTERCOMING HEAD
72.7   VACUUM EXTRACTION
72.71   VACUUM EXTRACTION WITH EPISIOTOMY
72.79   OTHER VACUUM EXTRACTION
72.8   OTHER SPECIFIED INSTRUMENTAL DELIVERY
72.9   UNSPECIFIED INSTRUMENTAL DELIVERY
73.0   ARTIFICIAL RUPTURE OF MEMBRANES
73.01   INDUCTION OF LABOR BY ARTIFICIAL RUPTURE OF MEMBRANES
73.09   OTHER ARTIFICIAL RUPTURE OF MEMBRANES
73.1   OTHER SURGICAL INDUCTION OF LABOR
73.2   INTERNAL AND COMBINED VERSION AND EXTRACTION
73.21   INTERNAL AND COMBINED VERSION WITHOUT EXTRACTION
73.22   INTERNAL AND COMBINED VERSION WITH EXTRACTION
73.3   FAILED FORCEPS
73.4   MEDICAL INDUCTION OF LABOR
73.5   MANUALLY ASSISTED DELIVERY
73.51   MANUAL ROTATION OF FETAL HEAD
73.59   OTHER MANUALLY ASSISTED DELIVERY
73.6   EPISIOTOMY
73.8   OPERATIONS ON FETUS TO FACILITATE DELIVERY
73.9   OTHER OPERATIONS ASSISTING DELIVERY
73.91   EXTERNAL VERSION ASSISTING DELIVERY
73.92   REPLACEMENT OF PROLAPSED UMBILICAL CORD
73.93   INCISION OF CERVIX TO ASSIST DELIVERY
73.94   PUBIOTOMY TO ASSIST DELIVERY
73.99   OTHER OPERATIONS ASSISTING DELIVERY
74.0   CLASSICAL CESAREAN SECTION
74.1   LOW CERVICAL CESAREAN SECTION
74.2   EXTRAPERITONEAL CESAREAN SECTION
Appendix A

74.3   REMOVAL OF EXTRATUBAL ECTOPIC PREGNANCY
74.4   CESAREAN SECTION OF OTHER SPECIFIED TYPE
74.9   CESAREAN SECTION OF UNSPECIFIED TYPE
74.91   HYSTEROTOMY TO TERMINATE PREGNANCY
74.99   OTHER CESAREAN SECTION OF UNSPECIFIED TYPE
75.4   MANUAL REMOVAL OF RETAINED PLACENTA
75.5   REPAIR OF CURRENT OBSTETRIC LACERATION OF UTERUS
75.6   REPAIR OF OTHER CURRENT OBSTETRIC LACERATION
75.7   MANUAL EXPLORATION OF UTERINE CAVITY, POSTPARTUM
75.9   OTHER OBSTETRIC OPERATIONS
Appendix A

AFTER PS MATCHING
Optum
MarketScan
Medicare
BEFORE PS MATCHING
The c-statistics for the propensity score model, pre-matching was 0.657. The post-matching c-statistic 
was 0.52.
The c-statistics for the propensity score model, pre-matching was 0.662. The post-matching 
c-statistic was 0.518.
The c-statistics for the propensity score model, pre-matching was 0.651. The post-matching c-statistic 
was 0.511.
Appendix B

Unmatched
Variable
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- 
Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
St. Diff.
Number of patients
                                       117,685                                           29,759 
124,594
                                      
43,306
                                         
306,304
                                    
103,677
                    
                                       548,583                                        176,742 
Age
...mean (sd)
69.87 (9.37)
69.12 (9.34)
67.93 (10.74)
66.24 (10.14)
75.78 (7.53)
75.65 (7.46)
72.73 (8.76)
72.24 (8.52)
0.06
...median [IQR]
70.00 [63.00, 77.00]
69.00 [62.00, 76.00]
66.00 [59.00, 77.00]
64.00 [59.00, 74.00]
75.00 [70.00, 81.00]5.00 [70.00, 81.00]
71.88 (8.76)
71.29 (8.52)
0.07
Age categories
...18 - 54; n (%)
7,614 (6.5%)
2,061 (6.9%)
12,188 (9.8%)
4,808 (11.1%)
0 (0.0%)
0 (0.0%)
19,802 (3.6%)
6,869 (3.9%)
-0.02
...55 - 64; n (%)
26,192 (22.3%)
7,381 (24.8%)
45,377 (36.4%)
18,182 (42.0%)
5,258 (1.7%)
1,675 (1.6%)
76,827 (14.0%)
27,238 (15.4%)
-0.04
...65 - 74; n (%)
43,590 (37.0%)
11,349 (38.1%)
29,690 (23.8%)
10,347 (23.9%)
143,586 (46.9%)
49,319 (47.6%)
216,866 (39.5%)
71,015 (40.2%)
-0.01
...>= 75; n (%)
40,289 (34.2%)
8,968 (30.1%)
37,339 (30.0%)
9,969 (23.0%)
157,460 (51.4%)
52,683 (50.8%)
235,088 (42.9%)
71,620 (40.5%)
0.05
Gender- 
...Males; n (%)
70,996 (60.3%)
16,783 (56.4%)
78,953 (63.4%)
26,549 (61.3%)
159,873 (52.2%)
49,637 (47.9%)
309,822 (56.5%)
92,969 (52.6%)
0.08
...Females; n (%)
46,689 (39.7%)
12,976 (43.6%)
45,641 (36.6%)
16,757 (38.7%)
146,431 (47.8%)
54,040 (52.1%)
238,761 (43.5%)
83,773 (47.4%)
-0.08
Race without zero category
...White; n (%)
N/A
N/A
N/A
N/A
243,220 (79.4%)
78,796 (76.0%)
243,220 (79.4%)
78,796 (76.0%)
0.08
...Black; n (%)
N/A
N/A
N/A
N/A
35,871 (11.7%)
12,037 (11.6%)
35,871 (11.7%)
12,037 (11.6%)
0.00
...Asian; n (%)
N/A
N/A
N/A
N/A
7,863 (2.6%)
4,365 (4.2%)
7,863 (2.6%)
4,365 (4.2%)
-0.09
...Hispanic; n (%)
N/A
N/A
N/A
N/A
10,197 (3.3%)
4,546 (4.4%)
10,197 (3.3%)
4,546 (4.4%)
-0.06
...North American Native; n (%)
N/A
N/A
N/A
N/A
1,936 (0.6%)
527 (0.5%)
1,936 (0.6%)
527 (0.5%)
0.01
...Other/Unknown; n (%)
N/A
N/A
N/A
N/A
7,217 (2.4%)
3,406 (3.3%)
7,217 (2.4%)
3,406 (3.3%)
-0.05
Region-   (lumping missing&other category with West)
...Northeast; n (%)
11,989 (10.2%)
4,227 (14.2%)
19,997 (16.0%)
9,324 (21.5%)
53,453 (17.5%)
24,496 (23.6%)
85,439 (15.6%)
38,047 (21.5%)
-0.15
...South; n (%)
57,501 (48.9%)
15,058 (50.6%)
40,843 (32.8%)
11,503 (26.6%)
136,902 (44.7%)
42,919 (41.4%)
235,246 (42.9%)
69,480 (39.3%)
0.07
...Midwest; n (%)
24,332 (20.7%)
5,057 (17.0%)
48,364 (38.8%)
17,570 (40.6%)
72,970 (23.8%)
19,059 (18.4%)
145,666 (26.6%)
41,686 (23.6%)
0.07
...West; n (%)
23,863 (20.3%)
5,417 (18.2%)
14,184 (11.4%)
4,488 (10.4%)
42,979 (14.0%)
17,203 (16.6%)
81,026 (14.8%)
27,108 (15.3%)
-0.01
...Unknown+missing; n (%)
N/A
N/A
1,206 (1.0%)
421 (1.0%)
N/A
N/A
1,206 (1.0%)
421 (1.0%)
0.00
CV Covariates
Ischemic heart disease; n (%)
78,804 (67.0%)
19,763 (66.4%)
79,177 (63.5%)
27,756 (64.1%)
208,853 (68.2%)
70,050 (67.6%)
366,834 (66.9%)
117,569 (66.5%)
0.01
Acute MI; n (%)
7,116 (6.0%)
1,556 (5.2%)
7,950 (6.4%)
2,449 (5.7%)
14,690 (4.8%)
4,757 (4.6%)
29,756 (5.4%)
8,762 (5.0%)
0.02
ACS/unstable angina; n (%)
6,453 (5.5%)
1,610 (5.4%)
7,089 (5.7%)
2,520 (5.8%)
12,974 (4.2%)
4,714 (4.5%)
26,516 (4.8%)
8,844 (5.0%)
-0.01
Old MI; n (%)
11,986 (10.2%)
2,817 (9.5%)
6,665 (5.3%)
2,069 (4.8%)
31,200 (10.2%)
9,830 (9.5%)
49,851 (9.1%)
14,716 (8.3%)
0.03
Stable angina; n (%)
9,950 (8.5%)
2,606 (8.8%)
8,129 (6.5%)
3,044 (7.0%)
22,435 (7.3%)
8,273 (8.0%)
40,514 (7.4%)
13,923 (7.9%)
-0.02
Coronary atherosclerosis and other forms of chronic 
ischemic heart disease; n (%)
74,752 (63.5%)
18,866 (63.4%)
75,286 (60.4%)
26,621 (61.5%)
201,279 (65.7%)
67,394 (65.0%)
351,317 (64.0%)
112,881 (63.9%)
0.00
Other atherosclerosis with ICD10  ; n (%)
3,467 (2.9%)
858 (2.9%)
3,167 (2.5%)
1,108 (2.6%)
10,599 (3.5%)
3,723 (3.6%)
17,233 (3.1%)
5,689 (3.2%)
-0.01
Previous cardiac procedure (CABG or PTCA or Stent) v4; n 
(%)
4,865 (4.1%)
1,125 (3.8%)
6,743 (5.4%)
2,291 (5.3%)
7,210 (2.4%)
2,586 (2.5%)
18,818 (3.4%)
6,002 (3.4%)
0.00
History of CABG or PTCA; n (%)
18,909 (16.1%)
4,629 (15.6%)
9,546 (7.7%)
3,482 (8.0%)
60,080 (19.6%)
19,148 (18.5%)
88,535 (16.1%)
27,259 (15.4%)
0.02
Any stroke; n (%)
25,490 (21.7%)
6,467 (21.7%)
26,317 (21.1%)
8,740 (20.2%)
73,052 (23.8%)
25,655 (24.7%)
124,859 (22.8%)
40,862 (23.1%)
-0.01
Ischemic stroke (w and w/o mention of cerebral 
infarction); n (%)
25,318 (21.5%)
6,437 (21.6%)
26,168 (21.0%)
8,684 (20.1%)
72,515 (23.7%)
25,469 (24.6%)
124,001 (22.6%)
40,590 (23.0%)
-0.01
Hemorrhagic stroke; n (%)
785 (0.7%)
181 (0.6%)
821 (0.7%)
273 (0.6%)
2,062 (0.7%)
741 (0.7%)
3,668 (0.7%)
1195 (0.7%)
0.00
TIA; n (%)
5,153 (4.4%)
1,294 (4.3%)
5,539 (4.4%)
1,696 (3.9%)
14,598 (4.8%)
5,155 (5.0%)
25,290 (4.6%)
8,145 (4.6%)
0.00
Other cerebrovascular disease; n (%)
5,877 (5.0%)
1,522 (5.1%)
4,899 (3.9%)
1,570 (3.6%)
18,592 (6.1%)
6,646 (6.4%)
29,368 (5.4%)
9,738 (5.5%)
0.00
Late effects of cerebrovascular disease; n (%)
6,322 (5.4%)
1,505 (5.1%)
4,660 (3.7%)
1,422 (3.3%)
19,216 (6.3%)
6,725 (6.5%)
30,198 (5.5%)
9,652 (5.5%)
0.00
Cerebrovascular procedure; n (%)
548 (0.5%)
95 (0.3%)
658 (0.5%)
185 (0.4%)
1,139 (0.4%)
370 (0.4%)
2,345 (0.4%)
650 (0.4%)
0.00
Heart failure (CHF); n (%)
24,633 (20.9%)
5,822 (19.6%)
20,633 (16.6%)
6,241 (14.4%)
74,334 (24.3%)
24,555 (23.7%)
119,600 (21.8%)
36,618 (20.7%)
0.03
Peripheral Vascular Disease (PVD) or PVD Surgery ; n (%)
17,611 (15.0%)
4,589 (15.4%)
14,270 (11.5%)
4,895 (11.3%)
60,993 (19.9%)
22,399 (21.6%)
92,874 (16.9%)
31,883 (18.0%)
-0.03
Atrial fibrillation; n (%)
17,961 (15.3%)
4,302 (14.5%)
16,153 (13.0%)
5,109 (11.8%)
64,943 (21.2%)
21,134 (20.4%)
99,057 (18.1%)
30,545 (17.3%)
0.02
Other cardiac dysrhythmia; n (%)
20,210 (17.2%)
5,107 (17.2%)
17,075 (13.7%)
5,812 (13.4%)
67,788 (22.1%)
23,313 (22.5%)
105,073 (19.2%)
34,232 (19.4%)
-0.01
Cardiac conduction disorders; n (%)
6,876 (5.8%)
1,676 (5.6%)
5,401 (4.3%)
1,770 (4.1%)
24,291 (7.9%)
7,964 (7.7%)
36,568 (6.7%)
11,410 (6.5%)
0.01
Other CVD; n (%)
28,933 (24.6%)
7,152 (24.0%)
26,394 (21.2%)
9,187 (21.2%)
86,701 (28.3%)
29,729 (28.7%)
142,028 (25.9%)
46,068 (26.1%)
0.00
Diabetes-related complications
Diabetic retinopathy; n (%)
6,792 (5.8%)
1,907 (6.4%)
4,974 (4.0%)
1,711 (4.0%)
19,459 (6.4%)
7,094 (6.8%)
31,225 (5.7%)
10,712 (6.1%)
-0.02
Diabetes with other ophthalmic manifestations; n (%)
543 (0.5%)
145 (0.5%)
3,717 (3.0%)
1,300 (3.0%)
7,490 (2.4%)
2,860 (2.8%)
11,750 (2.1%)
4,305 (2.4%)
-0.02
Unmatched
Optum
MarketScan
Medicare
POOLED
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Retinal detachment, vitreous hemorrhage, vitrectomy; n 
(%)
502 (0.4%)
149 (0.5%)
425 (0.3%)
169 (0.4%)
1,324 (0.4%)
477 (0.5%)
2,251 (0.4%)
795 (0.4%)
0.00
Retinal laser coagulation therapy; n (%)
687 (0.6%)
173 (0.6%)
814 (0.7%)
289 (0.7%)
1,636 (0.5%)
625 (0.6%)
3,137 (0.6%)
1,087 (0.6%)
0.00
Occurrence of Diabetic Neuropathy  ; n (%)
21,372 (18.2%)
5,846 (19.6%)
13,374 (10.7%)
4,906 (11.3%)
61,487 (20.1%)
22,354 (21.6%)
96,233 (17.5%)
33,106 (18.7%)
-0.03
Occurrence of diabetic nephropathy  with ICD10 ; n (%)
17,094 (14.5%)
4,492 (15.1%)
6,872 (5.5%)
2,490 (5.7%)
34,763 (11.3%)
11,686 (11.3%)
58,729 (10.7%)
18,668 (10.6%)
0.00
Hypoglycemia ; n (%)
4,301 (3.7%)
1,080 (3.6%)
4,669 (3.7%)
1,322 (3.1%)
11,714 (3.8%)
4,268 (4.1%)
20,684 (3.8%)
6,670 (3.8%)
0.00
Hyperglycemia; n (%)
6,940 (5.9%)
1,796 (6.0%)
4,682 (3.8%)
1,805 (4.2%)
20,768 (6.8%)
7,619 (7.3%)
32,390 (5.9%)
11,220 (6.3%)
-0.02
Disorders of fluid electrolyte and acid-base balance; n (%)
16,879 (14.3%)
4,101 (13.8%)
12,788 (10.3%)
3,971 (9.2%)
51,918 (16.9%)
17,299 (16.7%)
81,585 (14.9%)
25,371 (14.4%)
0.01
Diabetic ketoacidosis; n (%)
8 (0.0%)
4 (0.0%)
4 (0.0%)
6 (0.0%)
59 (0.0%)
29 (0.0%)
071 (0.0%)
39 (0.0%)
#DIV/0!
Hyperosmolar hyperglycemic nonketotic syndrome 
(HONK); n (%)
735 (0.6%)
186 (0.6%)
558 (0.4%)
219 (0.5%)
1,883 (0.6%)
782 (0.8%)
3,176 (0.6%)
1,187 (0.7%)
-0.01
Diabetes with peripheral circulatory disorders with ICD-
10  ; n (%)
10,913 (9.3%)
2,930 (9.8%)
6,325 (5.1%)
2,235 (5.2%)
30,630 (10.0%)
11,331 (10.9%)
47,868 (8.7%)
16,496 (9.3%)
-0.02
Diabetic Foot; n (%)
4,737 (4.0%)
1,128 (3.8%)
4,679 (3.8%)
1,315 (3.0%)
14,480 (4.7%)
4,711 (4.5%)
23,896 (4.4%)
7,154 (4.0%)
0.02
Gangrene ; n (%)
897 (0.8%)
213 (0.7%)
1,024 (0.8%)
259 (0.6%)
2,075 (0.7%)
645 (0.6%)
3,996 (0.7%)
1117 (0.6%)
0.01
Lower extremity amputation; n (%)
2,269 (1.9%)
560 (1.9%)
1,606 (1.3%)
406 (0.9%)
5,709 (1.9%)
1,731 (1.7%)
9,584 (1.7%)
2,697 (1.5%)
0.02
Osteomyelitis; n (%)
1,650 (1.4%)
400 (1.3%)
1,708 (1.4%)
464 (1.1%)
3,949 (1.3%)
1,281 (1.2%)
7,307 (1.3%)
2,145 (1.2%)
0.01
Skin infections ; n (%)
9,367 (8.0%)
2,364 (7.9%)
9,934 (8.0%)
3,078 (7.1%)
29,857 (9.7%)
10,257 (9.9%)
49,158 (9.0%)
15,699 (8.9%)
0.00
Erectile dysfunction; n (%)
2,941 (2.5%)
803 (2.7%)
2,179 (1.7%)
898 (2.1%)
6,731 (2.2%)
2,409 (2.3%)
11,851 (2.2%)
4,110 (2.3%)
-0.01
Diabetes with unspecified complication; n (%)
6,237 (5.3%)
1,854 (6.2%)
4,515 (3.6%)
1,863 (4.3%)
16,358 (5.3%)
6,490 (6.3%)
27,110 (4.9%)
10,207 (5.8%)
-0.04
Diabetes mellitus without mention of complications; n 
(%)
108,490 (92.2%)
27,552 (92.6%)
118,114 (94.8%)
41,128 (95.0%)
291,495 (95.2%)
98,958 (95.4%)
518,099 (94.4%)
167,638 (94.8%)
-0.02
Hypertension: 1 inpatient or 2 outpatient claims within 
365 days; n (%)
104,710 (89.0%)
26,803 (90.1%)
89,084 (71.5%)
31,959 (73.8%)
289,155 (94.4%)
98,398 (94.9%)
482,949 (88.0%)
157,160 (88.9%)
-0.03
Hyperlipidemia ; n (%)
88,208 (75.0%)
23,829 (80.1%)
66,037 (53.0%)
26,210 (60.5%)
241,943 (79.0%)
85,290 (82.3%)
396,188 (72.2%)
135,329 (76.6%)
-0.10
Edema; n (%)
12,166 (10.3%)
3,160 (10.6%)
8,422 (6.8%)
2,900 (6.7%)
43,638 (14.2%)
15,275 (14.7%)
64,226 (11.7%)
21,335 (12.1%)
-0.01
Renal Dysfunction (non-diabetic) ; n (%)
34,556 (29.4%)
8,697 (29.2%)
24,149 (19.4%)
7,618 (17.6%)
101,983 (33.3%)
33,219 (32.0%)
160,688 (29.3%)
49,534 (28.0%)
0.03
Occurrence of acute renal disease ; n (%)
9,176 (7.8%)
2,303 (7.7%)
7,529 (6.0%)
2,364 (5.5%)
27,683 (9.0%)
9,014 (8.7%)
44,388 (8.1%)
13,681 (7.7%)
0.01
Occurrence of chronic renal insufficiency; n (%)
26,299 (22.3%)
6,629 (22.3%)
15,567 (12.5%)
4,810 (11.1%)
80,327 (26.2%)
25,599 (24.7%)
122,193 (22.3%)
37,038 (21.0%)
0.03
Chronic kidney disease ; n (%)
25,427 (21.6%)
6,414 (21.6%)
15,096 (12.1%)
4,651 (10.7%)
76,724 (25.0%)
24,322 (23.5%)
117,247 (21.4%)
35,387 (20.0%)
0.03
CKD Stage 3-4; n (%)
16,485 (14.0%)
4,165 (14.0%)
9,049 (7.3%)
2,907 (6.7%)
50,577 (16.5%)
15,911 (15.3%)
76,111 (13.9%)
22,983 (13.0%)
0.03
Occurrence of hypertensive nephropathy; n (%)
13,898 (11.8%)
3,469 (11.7%)
7,405 (5.9%)
2,248 (5.2%)
44,203 (14.4%)
13,558 (13.1%)
65,506 (11.9%)
19,275 (10.9%)
0.03
Occurrence of miscellaneous renal insufficiency ; n (%)
11,417 (9.7%)
2,848 (9.6%)
8,521 (6.8%)
2,733 (6.3%)
36,288 (11.8%)
12,083 (11.7%)
56,226 (10.2%)
17,664 (10.0%)
0.01
Glaucoma or cataracts ; n (%)
22,045 (18.7%)
6,100 (20.5%)
19,768 (15.9%)
7,152 (16.5%)
75,520 (24.7%)
28,078 (27.1%)
117,333 (21.4%)
41,330 (23.4%)
-0.05
Cellulitis or abscess of toe; n (%)
2,530 (2.1%)
580 (1.9%)
1,977 (1.6%)
612 (1.4%)
6,701 (2.2%)
2,284 (2.2%)
11,208 (2.0%)
3,476 (2.0%)
0.00
Foot ulcer; n (%)
4,764 (4.0%)
1,126 (3.8%)
4,802 (3.9%)
1,346 (3.1%)
14,632 (4.8%)
4,749 (4.6%)
24,198 (4.4%)
7,221 (4.1%)
0.01
Bladder stones; n (%)
222 (0.2%)
47 (0.2%)
201 (0.2%)
57 (0.1%)
754 (0.2%)
262 (0.3%)
1,177 (0.2%)
366 (0.2%)
0.00
Kidney stones; n (%)
3,129 (2.7%)
875 (2.9%)
3,063 (2.5%)
1,111 (2.6%)
10,287 (3.4%)
3,806 (3.7%)
16,479 (3.0%)
5,792 (3.3%)
-0.02
Urinary tract infections (UTIs); n (%)
15,015 (12.8%)
3,954 (13.3%)
11,397 (9.1%)
3,910 (9.0%)
58,284 (19.0%)
22,343 (21.6%)
84,696 (15.4%)
30,207 (17.1%)
-0.05
Dipstick urinalysis; n (%)
41,828 (35.5%)
12,029 (40.4%)
36,355 (29.2%)
14,111 (32.6%)
136,259 (44.5%)
50,061 (48.3%)
214,442 (39.1%)
76,201 (43.1%)
-0.08
Non-dipstick urinalysis; n (%)
36,680 (31.2%)
10,741 (36.1%)
24,847 (19.9%)
10,552 (24.4%)
99,581 (32.5%)
36,845 (35.5%)
161,108 (29.4%)
58,138 (32.9%)
-0.08
Urine function test; n (%)
3,685 (3.1%)
966 (3.2%)
4,130 (3.3%)
1,563 (3.6%)
13,705 (4.5%)
5,353 (5.2%)
21,520 (3.9%)
7,882 (4.5%)
-0.03
Cytology; n (%)
2,085 (1.8%)
508 (1.7%)
2,891 (2.3%)
1,038 (2.4%)
6,823 (2.2%)
2,478 (2.4%)
11,799 (2.2%)
4,024 (2.3%)
-0.01
Cystos; n (%)
2,560 (2.2%)
656 (2.2%)
3,232 (2.6%)
1,103 (2.5%)
8,994 (2.9%)
3,007 (2.9%)
14,786 (2.7%)
4,766 (2.7%)
0.00
Other Covariates
Liver disease; n (%)
5,430 (4.6%)
1,451 (4.9%)
4,661 (3.7%)
1,750 (4.0%)
14,982 (4.9%)
5,840 (5.6%)
25,073 (4.6%)
9,041 (5.1%)
-0.02
Osteoarthritis; n (%)
21,010 (17.9%)
5,685 (19.1%)
16,332 (13.1%)
5,835 (13.5%)
81,257 (26.5%)
30,002 (28.9%)
118,599 (21.6%)
41,522 (23.5%)
-0.05
Other arthritis, arthropathies and musculoskeletal pain; n 
(%)
49,144 (41.8%)
13,202 (44.4%)
45,060 (36.2%)
16,081 (37.1%)
161,043 (52.6%)
58,296 (56.2%)
255,247 (46.5%)
87,579 (49.6%)
-0.06
Dorsopathies; n (%)
27,972 (23.8%)
7,679 (25.8%)
24,944 (20.0%)
9,217 (21.3%)
93,330 (30.5%)
33,983 (32.8%)
146,246 (26.7%)
50,879 (28.8%)
-0.05
Fractures; n (%)
5,255 (4.5%)
1,326 (4.5%)
5,354 (4.3%)
1,717 (4.0%)
18,468 (6.0%)
6,509 (6.3%)
29,077 (5.3%)
9,552 (5.4%)
0.00
Falls ; n (%)
6,284 (5.3%)
1,678 (5.6%)
1,959 (1.6%)
682 (1.6%)
23,069 (7.5%)
8,086 (7.8%)
31,312 (5.7%)
10,446 (5.9%)
-0.01
Osteoporosis; n (%)
6,103 (5.2%)
1,964 (6.6%)
4,918 (3.9%)
1,875 (4.3%)
24,889 (8.1%)
11,921 (11.5%)
35,910 (6.5%)
15,760 (8.9%)
-0.09
Hyperthyroidism; n (%)
847 (0.7%)
274 (0.9%)
612 (0.5%)
277 (0.6%)
3,328 (1.1%)
1,334 (1.3%)
4,787 (0.9%)
1,885 (1.1%)
-0.02
Hypothyroidism ; n (%)
17,253 (14.7%)
5,020 (16.9%)
11,089 (8.9%)
4,678 (10.8%)
50,836 (16.6%)
19,054 (18.4%)
79,178 (14.4%)
28,752 (16.3%)
-0.05
Other disorders of thyroid gland ; n (%)
3,725 (3.2%)
1,301 (4.4%)
3,046 (2.4%)
1,586 (3.7%)
12,920 (4.2%)
5,825 (5.6%)
19,691 (3.6%)
8,712 (4.9%)
-0.06
Depression; n (%)
12,117 (10.3%)
3,389 (11.4%)
9,066 (7.3%)
3,262 (7.5%)
44,576 (14.6%)
16,859 (16.3%)
65,759 (12.0%)
23,510 (13.3%)
-0.04
Anxiety; n (%)
9,087 (7.7%)
2,673 (9.0%)
5,448 (4.4%)
2,120 (4.9%)
34,453 (11.2%)
12,747 (12.3%)
48,988 (8.9%)
17,540 (9.9%)
-0.03
Sleep_Disorder; n (%)
11,137 (9.5%)
3,176 (10.7%)
12,982 (10.4%)
5,001 (11.5%)
33,719 (11.0%)
11,667 (11.3%)
57,838 (10.5%)
19,844 (11.2%)
-0.02
Dementia; n (%)
8,913 (7.6%)
2,271 (7.6%)
6,575 (5.3%)
1,940 (4.5%)
39,772 (13.0%)
14,957 (14.4%)
55,260 (10.1%)
19,168 (10.8%)
-0.02
Delirium; n (%)
3,536 (3.0%)
915 (3.1%)
3,307 (2.7%)
1,004 (2.3%)
13,751 (4.5%)
5,106 (4.9%)
20,594 (3.8%)
7,025 (4.0%)
-0.01
Psychosis; n (%)
2,382 (2.0%)
617 (2.1%)
2,097 (1.7%)
598 (1.4%)
11,025 (3.6%)
3,967 (3.8%)
15,504 (2.8%)
5,182 (2.9%)
-0.01
Obesity; n (%)
18,267 (15.5%)
5,260 (17.7%)
11,002 (8.8%)
4,542 (10.5%)
45,865 (15.0%)
16,121 (15.5%)
75,134 (13.7%)
25,923 (14.7%)
-0.03
Overweight; n (%)
4,108 (3.5%)
1,280 (4.3%)
1,273 (1.0%)
626 (1.4%)
10,394 (3.4%)
3,782 (3.6%)
15,775 (2.9%)
5,688 (3.2%)
-0.02
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Smoking; n (%)
18,795 (16.0%)
4,685 (15.7%)
9,206 (7.4%)
3,169 (7.3%)
62,562 (20.4%)
19,676 (19.0%)
90,563 (16.5%)
27,530 (15.6%)
0.02
Alcohol abuse or dependence; n (%)
1,421 (1.2%)
287 (1.0%)
966 (0.8%)
270 (0.6%)
2,989 (1.0%)
901 (0.9%)
5,376 (1.0%)
1,458 (0.8%)
0.02
Drug abuse or dependence; n (%)
1,825 (1.6%)
474 (1.6%)
875 (0.7%)
264 (0.6%)
4,320 (1.4%)
1,453 (1.4%)
7,020 (1.3%)
2,191 (1.2%)
0.01
COPD; n (%)
19,735 (16.8%)
4,681 (15.7%)
15,832 (12.7%)
4,907 (11.3%)
61,237 (20.0%)
20,088 (19.4%)
96,804 (17.6%)
29,676 (16.8%)
0.02
Asthma; n (%)
7,433 (6.3%)
2,141 (7.2%)
6,080 (4.9%)
2,268 (5.2%)
23,366 (7.6%)
8,761 (8.5%)
36,879 (6.7%)
13,170 (7.5%)
-0.03
Obstructive sleep apnea; n (%)
10,664 (9.1%)
3,106 (10.4%)
10,321 (8.3%)
4,281 (9.9%)
26,855 (8.8%)
9,150 (8.8%)
47,840 (8.7%)
16,537 (9.4%)
-0.02
Pneumonia; n (%)
7,668 (6.5%)
1,657 (5.6%)
7,710 (6.2%)
2,240 (5.2%)
23,525 (7.7%)
7,763 (7.5%)
38,903 (7.1%)
11,660 (6.6%)
0.02
Imaging; n (%)
634 (0.5%)
128 (0.4%)
394 (0.3%)
119 (0.3%)
1,614 (0.5%)
554 (0.5%)
2,642 (0.5%)
801 (0.5%)
0.00
Diabetes Medications
DM Medications - AGIs; n (%)
372 (0.3%)
96 (0.3%)
376 (0.3%)
139 (0.3%)
1,037 (0.3%)
431 (0.4%)
1,785 (0.3%)
666 (0.4%)
-0.02
DM Medications - Glitazones; n (%)
8,229 (7.0%)
2,709 (9.1%)
10,908 (8.8%)
4,523 (10.4%)
12,093 (3.9%)
6,087 (5.9%)
31,230 (5.7%)
13,319 (7.5%)
-0.07
DM Medications - GLP-1 RA; n (%)
509 (0.4%)
191 (0.6%)
563 (0.5%)
188 (0.4%)
850 (0.3%)
342 (0.3%)
1,922 (0.4%)
#VALUE!
#VALUE!
DM Medications - Insulin; n (%)
15,960 (13.6%)
5,836 (19.6%)
15,477 (12.4%)
6,702 (15.5%)
49,256 (16.1%)
22,937 (22.1%)
80,693 (14.7%)
35,475 (20.1%)
-0.14
DM Medications - Meglitinides; n (%)
942 (0.8%)
677 (2.3%)
1,640 (1.3%)
1,574 (3.6%)
3,540 (1.2%)
3,201 (3.1%)
6,122 (1.1%)
5,452 (3.1%)
-0.14
DM Medications - Metformin; n (%)
56,560 (48.1%)
17,047 (57.3%)
58,461 (46.9%)
25,481 (58.8%)
135,361 (44.2%)
57,121 (55.1%)
250,382 (45.6%)
99,649 (56.4%)
-0.22
Concomitant initiation or current use of SGLT2i; n (%)
994 (0.8%)
436 (1.5%)
690 (0.6%)
575 (1.3%)
1,805 (0.6%)
1,291 (1.2%)
3,489 (0.6%)
2,302 (1.3%)
-0.07
Concomitant initiation or current use of AGIs; n (%)
253 (0.2%)
64 (0.2%)
280 (0.2%)
92 (0.2%)
704 (0.2%)
304 (0.3%)
1,237 (0.2%)
460 (0.3%)
-0.02
Concomitant initiation or current use of Glitazones; n (%)
5,587 (4.7%)
1,440 (4.8%)
7,210 (5.8%)
2,282 (5.3%)
7,638 (2.5%)
3,431 (3.3%)
20,435 (3.7%)
7,153 (4.0%)
-0.02
Concomitant initiation or current use of GLP-1 RA; n (%)
227 (0.2%)
68 (0.2%)
312 (0.3%)
57 (0.1%)
327 (0.1%)
113 (0.1%)
#VALUE!
#VALUE!
#VALUE!
Concomitant initiation or current use of Insulin; n (%)
10,116 (8.6%)
3,986 (13.4%)
9,739 (7.8%)
4,333 (10.0%)
31,424 (10.3%)
15,966 (15.4%)
51,279 (9.3%)
24,285 (13.7%)
-0.14
Concomitant initiation or current use of Meglitinides; n 
(%)
535 (0.5%)
485 (1.6%)
950 (0.8%)
1,104 (2.5%)
2,171 (0.7%)
2,367 (2.3%)
3,656 (0.7%)
3,956 (2.2%)
-0.13
Concomitant initiation or current use of Metformin; n (%)
42,837 (36.4%)
13,655 (45.9%)
44,541 (35.7%)
20,708 (47.8%)
98,310 (32.1%)
44,919 (43.3%)
185,688 (33.8%)
79,282 (44.9%)
-0.23
Past use of SGLT2i; n (%)
445 (0.4%)
209 (0.7%)
315 (0.3%)
214 (0.5%)
1,055 (0.3%)
568 (0.5%)
1,815 (0.3%)
991 (0.6%)
-0.04
Past use of AGIs ; n (%)
119 (0.1%)
32 (0.1%)
96 (0.1%)
47 (0.1%)
333 (0.1%)
127 (0.1%)
548 (0.1%)
206 (0.1%)
0.00
Past use of Glitazones ; n (%)
2,642 (2.2%)
1,269 (4.3%)
3,699 (3.0%)
2,241 (5.2%)
4,455 (1.5%)
2,656 (2.6%)
10,796 (2.0%)
6,166 (3.5%)
-0.09
Past use of GLP-1 RA ; n (%)
292 (0.2%)
124 (0.4%)
255 (0.2%)
134 (0.3%)
523 (0.2%)
229 (0.2%)
1,070 (0.2%)
487 (0.3%)
-0.02
Past use of Insulin ; n (%)
5,844 (5.0%)
1,850 (6.2%)
5,738 (4.6%)
2,370 (5.5%)
17,835 (5.8%)
6,974 (6.7%)
29,417 (5.4%)
11,194 (6.3%)
-0.04
Past use of Meglitinides ; n (%)
407 (0.3%)
192 (0.6%)
690 (0.6%)
470 (1.1%)
1,369 (0.4%)
834 (0.8%)
2,466 (0.4%)
1,496 (0.8%)
-0.05
Past use of metformin (final) ; n (%)
13,723 (11.7%)
3,392 (11.4%)
13,920 (11.2%)
4,773 (11.0%)
37,051 (12.1%)
12,202 (11.8%)
64,694 (11.8%)
20,367 (11.5%)
0.01
Other Medications
Use of ACE inhibitors; n (%)
54,239 (46.1%)
12,202 (41.0%)
56,542 (45.4%)
18,022 (41.6%)
131,273 (42.9%)
40,555 (39.1%)
242,054 (44.1%)
70,779 (40.0%)
0.08
Use of ARBs; n (%)
25,030 (21.3%)
8,315 (27.9%)
28,565 (22.9%)
12,351 (28.5%)
76,768 (25.1%)
32,742 (31.6%)
130,363 (23.8%)
53,408 (30.2%)
-0.14
Use of Loop Diuretics - ; n (%)
28,952 (24.6%)
6,708 (22.5%)
30,314 (24.3%)
9,013 (20.8%)
93,126 (30.4%)
29,520 (28.5%)
152,392 (27.8%)
45,241 (25.6%)
0.05
Use of other diuretics- ; n (%)
5,674 (4.8%)
1,464 (4.9%)
6,178 (5.0%)
2,066 (4.8%)
17,047 (5.6%)
5,658 (5.5%)
28,899 (5.3%)
9,188 (5.2%)
0.00
Use of nitrates-; n (%)
17,689 (15.0%)
4,233 (14.2%)
21,232 (17.0%)
6,834 (15.8%)
52,053 (17.0%)
17,114 (16.5%)
90,974 (16.6%)
28,181 (15.9%)
0.02
Use of other hypertension drugs; n (%)
12,758 (10.8%)
2,776 (9.3%)
12,657 (10.2%)
3,485 (8.0%)
37,331 (12.2%)
11,366 (11.0%)
62,746 (11.4%)
17,627 (10.0%)
0.05
Use of digoxin- ; n (%)
5,809 (4.9%)
1,265 (4.3%)
7,057 (5.7%)
2,115 (4.9%)
17,623 (5.8%)
5,746 (5.5%)
30,489 (5.6%)
9,126 (5.2%)
0.02
Use of Anti-arrhythmics; n (%)
4,023 (3.4%)
1,037 (3.5%)
5,048 (4.1%)
1,661 (3.8%)
13,423 (4.4%)
4,451 (4.3%)
22,494 (4.1%)
7,149 (4.0%)
0.01
Use of COPD/asthma meds- ; n (%)
18,132 (15.4%)
5,349 (18.0%)
20,060 (16.1%)
7,587 (17.5%)
57,441 (18.8%)
22,852 (22.0%)
95,633 (17.4%)
35,788 (20.2%)
-0.07
Use of statins; n (%)
78,990 (67.1%)
21,287 (71.5%)
84,053 (67.5%)
31,003 (71.6%)
212,184 (69.3%)
75,861 (73.2%)
375,227 (68.4%)
128,151 (72.5%)
-0.09
Use of other lipid-lowering drugs; n (%)
14,917 (12.7%)
4,648 (15.6%)
20,396 (16.4%)
8,393 (19.4%)
36,070 (11.8%)
14,623 (14.1%)
71,383 (13.0%)
27,664 (15.7%)
-0.08
Use of antiplatelet agents; n (%)
32,387 (27.5%)
8,801 (29.6%)
40,482 (32.5%)
14,677 (33.9%)
84,313 (27.5%)
30,711 (29.6%)
157,182 (28.7%)
54,189 (30.7%)
-0.04
Use of oral anticoagulants (Dabigatran, Rivaroxaban, 
Apixaban, Warfarin); n (%)
13,819 (11.7%)
3,377 (11.3%)
15,147 (12.2%)
4,720 (10.9%)
48,289 (15.8%)
15,695 (15.1%)
77,255 (14.1%)
23,792 (13.5%)
0.02
Use of heparin and other low-molecular weight heparins; 
n (%)
1,120 (1.0%)
249 (0.8%)
84 (0.1%)
31 (0.1%)
2,943 (1.0%)
937 (0.9%)
4,147 (0.8%)
1,217 (0.7%)
0.01
Use of NSAIDs; n (%)
14,354 (12.2%)
4,038 (13.6%)
15,019 (12.1%)
5,782 (13.4%)
42,896 (14.0%)
17,195 (16.6%)
72,269 (13.2%)
27,015 (15.3%)
-0.06
Use of oral corticosteroids; n (%)
20,557 (17.5%)
5,245 (17.6%)
21,988 (17.6%)
7,546 (17.4%)
66,685 (21.8%)
22,585 (21.8%)
109,230 (19.9%)
35,376 (20.0%)
0.00
Use of bisphosphonate (); n (%)
2,897 (2.5%)
926 (3.1%)
3,145 (2.5%)
1,139 (2.6%)
9,018 (2.9%)
4,530 (4.4%)
15,060 (2.7%)
6,595 (3.7%)
-0.06
Use of opioids- ; n (%)
35,963 (30.6%)
9,123 (30.7%)
40,525 (32.5%)
13,385 (30.9%)
100,549 (32.8%)
33,144 (32.0%)
177,037 (32.3%)
55,652 (31.5%)
0.02
Use of antidepressants; n (%)
27,916 (23.7%)
7,888 (26.5%)
28,755 (23.1%)
10,402 (24.0%)
86,397 (28.2%)
32,027 (30.9%)
143,068 (26.1%)
50,317 (28.5%)
-0.05
Use of antipsychotics; n (%)
3,309 (2.8%)
989 (3.3%)
3,200 (2.6%)
1,004 (2.3%)
13,359 (4.4%)
5,613 (5.4%)
19,868 (3.6%)
7,606 (4.3%)
-0.04
Use of anticonvulsants; n (%)
19,086 (16.2%)
5,320 (17.9%)
17,058 (13.7%)
6,022 (13.9%)
62,576 (20.4%)
22,838 (22.0%)
98,720 (18.0%)
34,180 (19.3%)
-0.03
Use of lithium- ; n (%)
152 (0.1%)
46 (0.2%)
176 (0.1%)
63 (0.1%)
380 (0.1%)
124 (0.1%)
708 (0.1%)
233 (0.1%)
0.00
Use of Benzos- ; n (%)
11,453 (9.7%)
3,378 (11.4%)
17,055 (13.7%)
5,882 (13.6%)
37,412 (12.2%)
13,247 (12.8%)
65,920 (12.0%)
22,507 (12.7%)
-0.02
Use of anxiolytics/hypnotics- ; n (%)
7,983 (6.8%)
2,254 (7.6%)
9,769 (7.8%)
3,688 (8.5%)
22,911 (7.5%)
9,271 (8.9%)
40,663 (7.4%)
15,213 (8.6%)
-0.04
Use of dementia meds- ; n (%)
4,036 (3.4%)
1,145 (3.8%)
4,105 (3.3%)
1,213 (2.8%)
20,223 (6.6%)
8,743 (8.4%)
28,364 (5.2%)
11,101 (6.3%)
-0.05
Use of antiparkinsonian meds- ; n (%)
3,220 (2.7%)
916 (3.1%)
3,571 (2.9%)
1,193 (2.8%)
12,914 (4.2%)
4,733 (4.6%)
19,705 (3.6%)
6,842 (3.9%)
-0.02
Any use of pramlintide; n (%)
17 (0.0%)
9 (0.0%)
49 (0.0%)
37 (0.1%)
24 (0.0%)
29 (0.0%)
090 (0.0%)
075 (0.0%)
#DIV/0!
Any use of 1st generation sulfonylureas; n (%)
80 (0.1%)
11 (0.0%)
190 (0.2%)
15 (0.0%)
210 (0.1%)
27 (0.0%)
480 (0.1%)
053 (0.0%)
0.00
Entresto (sacubitril/valsartan); n (%)
189 (0.2%)
65 (0.2%)
44 (0.0%)
20 (0.0%)
248 (0.1%)
120 (0.1%)
481 (0.1%)
205 (0.1%)
0.00
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Initiation as monotherapy v4 ; n (%)
30,107 (25.6%)
7,242 (24.3%)
29,945 (24.0%)
10,416 (24.1%)
63,712 (20.8%)
20,833 (20.1%)
123,764 (22.6%)
38,491 (21.8%)
0.02
Labs
                                       242,279                                           73,065 
Lab values- HbA1c (%) ; n (%)
29,636 (25.2%)
8,836 (29.7%)
4,979 (4.0%)
1,899 (4.4%)
N/A
N/A
34,615 (14.3%)
10,735 (14.7%)
-0.01
Lab values- HbA1c (%) (within 3 months) ; n (%)
22,154 (18.8%)
6,713 (22.6%)
3,792 (3.0%)
1,466 (3.4%)
N/A
N/A
25,946 (10.7%)
8,179 (11.2%)
-0.02
Lab values- HbA1c (%) (within 6 months) ; n (%)
29,636 (25.2%)
8,836 (29.7%)
4,979 (4.0%)
1,899 (4.4%)
N/A
N/A
34,615 (14.3%)
10,735 (14.7%)
-0.01
Lab values- BNP; n (%)
1,183 (1.0%)
355 (1.2%)
168 (0.1%)
74 (0.2%)
N/A
N/A
1,351 (0.6%)
429 (0.6%)
0.00
Lab values- BNP (within 3 months); n (%)
761 (0.6%)
220 (0.7%)
112 (0.1%)
54 (0.1%)
N/A
N/A
873 (0.4%)
274 (0.4%)
0.00
Lab values- BNP (within 6 months); n (%)
1,183 (1.0%)
355 (1.2%)
168 (0.1%)
74 (0.2%)
N/A
N/A
1,351 (0.6%)
429 (0.6%)
0.00
Lab values- BUN (mg/dl); n (%)
32,750 (27.8%)
9,782 (32.9%)
4,699 (3.8%)
2,083 (4.8%)
N/A
N/A
37,449 (15.5%)
11,865 (16.2%)
-0.02
Lab values- BUN (mg/dl) (within 3 months); n (%)
24,568 (20.9%)
7,492 (25.2%)
3,526 (2.8%)
1,589 (3.7%)
N/A
N/A
28,094 (11.6%)
9,081 (12.4%)
-0.02
Lab values- BUN (mg/dl) (within 6 months); n (%)
32,750 (27.8%)
9,782 (32.9%)
4,699 (3.8%)
2,083 (4.8%)
N/A
N/A
37,449 (15.5%)
11,865 (16.2%)
-0.02
Lab values- Creatinine (mg/dl) ; n (%)
33,612 (28.6%)
10,026 (33.7%)
4,992 (4.0%)
2,214 (5.1%)
N/A
N/A
38,604 (15.9%)
12,240 (16.8%)
-0.02
Lab values- Creatinine (mg/dl) (within 3 months) ; n (%)
25,223 (21.4%)
7,691 (25.8%)
3,751 (3.0%)
1,680 (3.9%)
N/A
N/A
28,974 (12.0%)
9,371 (12.8%)
-0.02
Lab values- Creatinine (mg/dl) (within 6 months) ; n (%)
33,612 (28.6%)
10,026 (33.7%)
4,992 (4.0%)
2,214 (5.1%)
N/A
N/A
38,604 (15.9%)
12,240 (16.8%)
-0.02
Lab values- HDL level (mg/dl); n (%)
25,367 (21.6%)
7,868 (26.4%)
4,371 (3.5%)
1,733 (4.0%)
N/A
N/A
29,738 (12.3%)
9,601 (13.1%)
-0.02
Lab values- HDL level (mg/dl) (within 3 months); n (%)
17,842 (15.2%)
5,652 (19.0%)
3,126 (2.5%)
1,273 (2.9%)
N/A
N/A
20,968 (8.7%)
6,925 (9.5%)
-0.03
Lab values- HDL level (mg/dl) (within 6 months); n (%)
25,367 (21.6%)
7,868 (26.4%)
4,371 (3.5%)
1,733 (4.0%)
N/A
N/A
29,738 (12.3%)
9,601 (13.1%)
-0.02
Lab values- LDL level (mg/dl) ; n (%)
26,132 (22.2%)
8,058 (27.1%)
4,734 (3.8%)
1,843 (4.3%)
N/A
N/A
30,866 (12.7%)
9,901 (13.6%)
-0.03
Lab values- LDL level (mg/dl) (within 3 months) ; n (%)
18,361 (15.6%)
5,776 (19.4%)
3,399 (2.7%)
1,353 (3.1%)
N/A
N/A
21,760 (9.0%)
7,129 (9.8%)
-0.03
Lab values- LDL level (mg/dl) (within 6 months) ; n (%)
26,132 (22.2%)
8,058 (27.1%)
4,734 (3.8%)
1,843 (4.3%)
N/A
N/A
30,866 (12.7%)
9,901 (13.6%)
-0.03
Lab values- NT-proBNP; n (%)
147 (0.1%)
44 (0.1%)
13 (0.0%)
4 (0.0%)
N/A
N/A
160 (0.1%)
48 (0.1%)
0.00
Lab values- NT-proBNP (within 3 months); n (%)
87 (0.1%)
20 (0.1%)
7 (0.0%)
2 (0.0%)
N/A
N/A
94 (0.0%)
22 (0.0%)
-
Lab values- NT-proBNP (within 6 months); n (%)
147 (0.1%)
44 (0.1%)
13 (0.0%)
4 (0.0%)
N/A
N/A
160 (0.1%)
48 (0.1%)
-
Lab values- Total cholesterol (mg/dl) ; n (%)
25,813 (21.9%)
7,987 (26.8%)
4,557 (3.7%)
1,811 (4.2%)
N/A
N/A
30,370 (12.5%)
9,798 (13.4%)
-0.03
Lab values- Total cholesterol (mg/dl) (within 3 months) ; n 
(%)
18,137 (15.4%)
5,731 (19.3%)
3,255 (2.6%)
1,323 (3.1%)
N/A
N/A
21,392 (8.8%)
7,054 (9.7%)
-0.03
Lab values- Total cholesterol (mg/dl) (within 6 months) ; n 
(%)
25,813 (21.9%)
7,987 (26.8%)
4,557 (3.7%)
1,811 (4.2%)
N/A
N/A
30,370 (12.5%)
9,798 (13.4%)
-0.03
Lab values- Triglyceride level (mg/dl); n (%)
25,491 (21.7%)
7,878 (26.5%)
4,465 (3.6%)
1,779 (4.1%)
N/A
N/A
29,956 (12.4%)
9,657 (13.2%)
-0.02
Lab values- Triglyceride level (mg/dl) (within 3 months); n 
(%)
17,919 (15.2%)
5,649 (19.0%)
3,196 (2.6%)
1,307 (3.0%)
N/A
N/A
21,115 (8.7%)
6,956 (9.5%)
-0.03
Lab values- Triglyceride level (mg/dl) (within 6 months); n 
(%)
25,491 (21.7%)
7,878 (26.5%)
4,465 (3.6%)
1,779 (4.1%)
N/A
N/A
29,956 (12.4%)
9,657 (13.2%)
-0.02
Lab result number- HbA1c (%) mean (only 2 to 20 
included) v4
29,363
                                         
8,750
                                            
4,334
                                            
1,833
                                            
N/A
N/A                                           33,697                                           10,583 
...mean (sd)
7.89 (1.77)
7.78 (1.69)
8.01 (1.85)
7.92 (1.76)
N/A
N/A
7.91 (1.78)
7.80 (1.70)
0.06
...median [IQR]
7.45 [6.70, 8.65]
7.40 [6.60, 8.50]
7.50 [6.70, 8.80]
7.50 [6.70, 8.70]
N/A
N/A
7.46 (1.78)
7.42 (1.70)
0.02
...Missing; n (%)
88,322 (75.0%)
21,009 (70.6%)
120,260 (96.5%)
41,473 (95.8%)
N/A
N/A
208,582 (86.1%)
62,482 (85.5%)
0.02
Lab result number- BNP mean 
1,183
                                            
355
                                                
168
                                                
74
                                                   
N/A
N/A                                              1,351                                                  429 
...mean (sd)
302.70 (552.45)
212.12 (352.66)
339.91 (671.94)
210.76 (314.60)
N/A
N/A
307.33 (568.82)
211.89 (346.86)
0.20
...median [IQR]
127.33 [46.80, 331.80]
106.50 [36.60, 238.00]
93.50 [37.50, 330.50]
100.50 [30.75, 261.62]
N/A
N/A
#VALUE!
105.47 (346.86)
#VALUE!
...Missing; n (%)
116,502 (99.0%)
29,404 (98.8%)
124,426 (99.9%)
43,232 (99.8%)
N/A
N/A
240,928 (99.4%)
72,636 (99.4%)
0.00
Lab result number- BUN (mg/dl) mean 
                                          32,750                                              9,782                                              4,699                                              2,083 
N/A
N/A                                           37,449                                           11,865 
...mean (sd)
20.84 (10.09)
20.26 (9.38)
705.76 (11,062.74)
217.15 (4,979.06)
N/A
N/A
106.78 (3918.48)
54.83 (2085.99)
0.02
...median [IQR]
18.33 [14.50, 24.33]
18.00 [14.00, 23.75]
18.00 [14.00, 23.00]
17.00 [14.00, 22.00]
N/A
N/A
#VALUE!
#VALUE!
#VALUE!
...Missing; n (%)
84,935 (72.2%)
19,977 (67.1%)
119,895 (96.2%)
41,223 (95.2%)
N/A
N/A
204,830 (84.5%)
61,200 (83.8%)
0.02
Lab result number- Creatinine (mg/dl) mean (only 0.1 to 
15 included) 
                                          33,274                                              9,917                                              4,811                                              2,079 
N/A
N/A                                           38,085                                           11,996 
...mean (sd)
1.16 (0.58)
1.13 (0.55)
1.11 (0.58)
1.05 (0.51)
N/A
N/A
1.15 (0.58)
1.12 (0.54)
0.05
...median [IQR]
1.04 [0.85, 1.31]
1.02 [0.84, 1.28]
1.00 [0.83, 1.22]
0.98 [0.81, 1.15]
N/A
N/A
1.03 (0.58)
1.01 (0.54)
0.04
...Missing; n (%)
84,411 (71.7%)
19,842 (66.7%)
119,783 (96.1%)
41,227 (95.2%)
N/A
N/A
204,194 (84.3%)
61,069 (83.6%)
0.02
Lab result number- HDL level (mg/dl) mean (only =<5000 
included) 
                                          25,367                                              7,868                                              4,357                                              1,732 
N/A
N/A                                           29,724                                              9,600 
...mean (sd)
44.55 (13.79)
45.39 (14.02)
44.51 (66.02)
43.66 (14.21)
N/A
N/A
44.54 (28.30)
45.08 (14.06)
-0.02
...median [IQR]
43.00 [35.50, 52.00]
44.00 [36.00, 53.00]
42.00 [35.00, 50.00]
42.00 [35.00, 51.00]
N/A
N/A
42.85 (28.30)
43.64 (14.06)
-0.04
...Missing; n (%)
92,318 (78.4%)
21,891 (73.6%)
120,237 (96.5%)
41,574 (96.0%)
N/A
N/A
212,555 (87.7%)
63,465 (86.9%)
0.02
Lab result number- LDL level (mg/dl) mean (only =<5000 
included) 
                                          25,614                                              7,895                                              4,389                                              1,745 
N/A
N/A                                           30,003                                              9,640 
...mean (sd)
85.78 (41.18)
83.18 (39.96)
88.03 (42.48)
86.46 (42.72)
N/A
N/A
86.11 (41.37)
83.77 (40.48)
0.06
...median [IQR]
82.00 [61.00, 109.00]
79.40 [59.00, 104.00]
85.00 [62.00, 111.00]
83.00 [62.00, 110.50]
N/A
N/A
82.44 (41.37)
80.05 (40.48)
0.06
...Missing; n (%)
92,071 (78.2%)
21,864 (73.5%)
120,205 (96.5%)
41,561 (96.0%)
N/A
N/A
212,276 (87.6%)
63,425 (86.8%)
0.02
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Lab result number- Total cholesterol (mg/dl) mean (only 
=<5000 included) 
                                          25,796                                              7,976                                              4,539                                              1,807 
N/A
N/A                                           30,335                                              9,783 
...mean (sd)
170.43 (50.39)
167.26 (48.36)
173.43 (50.55)
171.71 (52.14)
N/A
N/A
170.88 (50.41)
168.08 (49.08)
0.06
...median [IQR]
164.00 [138.00, 197.00]
161.00 [136.50, 191.50]
167.00 [141.00, 200.00]
166.00 [140.00, 198.00]
N/A
N/A
164.45 (50.41)
161.92 (49.08)
0.05
...Missing; n (%)
91,889 (78.1%)
21,783 (73.2%)
120,055 (96.4%)
41,499 (95.8%)
N/A
N/A
211,944 (87.5%)
63,282 (86.6%)
0.03
Lab result number- Triglyceride level (mg/dl) mean (only 
=<5000 included) 
                                          25,488                                              7,878                                              4,450                                              1,778 
N/A
N/A                                           29,938                                              9,656 
...mean (sd)
185.44 (156.55)
178.86 (148.70)
192.77 (168.94)
192.68 (182.22)
N/A
N/A
186.53 (158.46)
181.40 (155.42)
0.03
...median [IQR]
150.00 [107.00, 217.00]
146.00 [104.00, 210.00]
152.25 [109.00, 220.62]
150.00 [106.00, 221.00]
N/A
N/A
150.33 (158.46)
146.74 (155.42)
0.02
...Missing; n (%)
92,197 (78.3%)
21,881 (73.5%)
120,144 (96.4%)
41,528 (95.9%)
N/A
N/A
212,341 (87.6%)
63,409 (86.8%)
0.02
Lab result number- Hemoglobin mean (only >0 included)
                                          23,872                                              7,214                                              3,292                                              1,439 
N/A
N/A                                           27,164                                              8,653 
...mean (sd)
13.24 (1.82)
13.26 (1.76)
5,116.60 (195,020.21)
313.03 (6,066.36)
N/A
N/A
631.72 (67884.51)
63.11 (2473.43)
0.01
...median [IQR]
13.30 [12.05, 14.50]
13.30 [12.10, 14.50]
13.50 [12.20, 14.65]
13.50 [12.25, 14.70]
N/A
N/A
#VALUE!
#VALUE!
#VALUE!
...Missing; n (%)
93,813 (79.7%)
22,545 (75.8%)
121,302 (97.4%)
41,867 (96.7%)
N/A
N/A
215,115 (88.8%)
64,412 (88.2%)
0.02
Lab result number- Serum sodium mean (only > 90 and < 
190 included)
                                          32,487                                              9,706                                              4,212                                              1,898 
N/A
N/A                                           36,699                                           11,604 
...mean (sd)
139.35 (2.92)
139.52 (2.83)
138.95 (2.86)
139.10 (2.73)
N/A
N/A
139.30 (2.91)
139.45 (2.81)
-0.05
...median [IQR]
139.50 [138.00, 141.00]
140.00 [138.00, 141.33]
139.00 [137.25, 141.00]
139.00 [137.65, 141.00]
N/A
N/A
139.44 (2.91)
139.84 (2.81)
-0.14
...Missing; n (%)
85,198 (72.4%)
20,053 (67.4%)
120,382 (96.6%)
41,408 (95.6%)
N/A
N/A
205,580 (84.9%)
61,461 (84.1%)
0.02
Lab result number- Albumin mean (only >0 and <=10 
included)
                                          29,792                                              9,021                                              3,808                                              1,707 
N/A
N/A                                           33,600                                           10,728 
...mean (sd)
4.16 (0.35)
4.17 (0.35)
4.15 (0.50)
4.14 (0.59)
N/A
N/A
4.16 (0.37)
4.17 (0.40)
-0.03
...median [IQR]
4.20 [4.00, 4.40]
4.20 [4.00, 4.40]
4.20 [4.00, 4.40]
4.20 [4.00, 4.45]
N/A
N/A
4.20 (0.37)
4.20 (0.40)
0.00
...Missing; n (%)
87,893 (74.7%)
20,738 (69.7%)
120,786 (96.9%)
41,599 (96.1%)
N/A
N/A
208,679 (86.1%)
62,337 (85.3%)
0.02
Lab result number- Glucose (fasting or random) mean 
(only 10-1000 included)
                                          32,468                                              9,708                                              4,185                                              1,876 
N/A
N/A                                           36,653                                           11,584 
...mean (sd)
166.92 (73.20)
161.27 (67.25)
170.78 (75.20)
164.77 (71.73)
N/A
N/A
167.36 (73.43)
161.84 (68.00)
0.08
...median [IQR]
148.00 [119.00, 193.00]
144.00 [117.00, 185.00]
151.00 [121.00, 198.75]
145.00 [119.08, 189.00]
N/A
N/A
148.34 (73.43)
144.16 (68.00)
0.06
...Missing; n (%)
85,217 (72.4%)
20,051 (67.4%)
120,409 (96.6%)
41,430 (95.7%)
N/A
N/A
205,626 (84.9%)
61,481 (84.1%)
0.02
Lab result number- Potassium mean (only 1-7 included)
                                          33,114                                              9,891                                              4,624                                              2,044 
N/A
N/A                                           37,738                                           11,935 
...mean (sd)
4.45 (0.46)
4.43 (0.45)
4.38 (0.45)
4.38 (0.44)
N/A
N/A
4.44 (0.46)
4.42 (0.45)
0.04
...median [IQR]
4.40 [4.15, 4.70]
4.40 [4.12, 4.70]
4.40 [4.10, 4.70]
4.40 [4.10, 4.65]
N/A
N/A
4.40 (0.46)
4.40 (0.45)
0.00
...Missing; n (%)
84,571 (71.9%)
19,868 (66.8%)
119,970 (96.3%)
41,262 (95.3%)
N/A
N/A
204,541 (84.4%)
61,130 (83.7%)
0.02
Comorbidity Scores
CCI (180 days)- ICD9 and ICD10 
...mean (sd)
3.56 (2.35)
3.54 (2.35)
2.65 (2.17)
2.56 (2.12)
4.15 (2.42)
4.19 (2.41)
3.68 (2.35)
3.68 (2.33)
0.00
...median [IQR]
3.00 [2.00, 5.00]
3.00 [2.00, 5.00]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
4.00 [2.00, 6.00]
4.00 [2.00, 6.00]
3.33 (2.35)
3.34 (2.33)
0.00
Frailty Score: Qualitative Version 365 days as Categories, 
v1
...0; n (%)
21,406 (18.2%)
5,871 (19.7%)
6,853 (5.5%)
3,610 (8.3%)
41,807 (13.6%)
15,665 (15.1%)
70,066 (12.8%)
25,146 (14.2%)
-0.04
...1 to 2; n (%)
39,327 (33.4%)
10,519 (35.3%)
51,129 (41.0%)
18,494 (42.7%)
73,716 (24.1%)
24,561 (23.7%)
164,172 (29.9%)
53,574 (30.3%)
-0.01
...3 or more; n (%)
56,952 (48.4%)
13,369 (44.9%)
66,612 (53.5%)
21,202 (49.0%)
190,781 (62.3%)
63,451 (61.2%)
314,345 (57.3%)
98,022 (55.5%)
0.04
Frailty Score: Empirical Version 365 days as Categories, 
...< 0.12908; n (%)
5,864 (5.0%)
1,676 (5.6%)
6,888 (5.5%)
2,978 (6.9%)
5,981 (2.0%)
2,264 (2.2%)
18,733 (3.4%)
6,918 (3.9%)
-0.03
...0.12908 - 0.1631167; n (%)
24,734 (21.0%)
6,531 (21.9%)
27,427 (22.0%)
10,535 (24.3%)
31,035 (10.1%)
10,737 (10.4%)
83,196 (15.2%)
27,803 (15.7%)
-0.01
...>= 0.1631167; n (%)
87,087 (74.0%)
21,552 (72.4%)
90,279 (72.5%)
29,793 (68.8%)
269,288 (87.9%)
90,676 (87.5%)
446,654 (81.4%)
142,021 (80.4%)
0.03
Non-Frailty; n (%)
62,261 (52.9%)
16,998 (57.1%)
58,216 (46.7%)
21,937 (50.7%)
11,446 (3.7%)
3,726 (3.6%)
131,923 (24.0%)
42,661 (24.1%)
0.00
Frailty Score (mean): Qualitative Version 365 days, v1
...mean (sd)
2.97 (2.65)
2.75 (2.55)
3.19 (2.29)
2.94 (2.24)
3.78 (2.89)
3.74 (2.95)
3.47 (2.71)
3.38 (2.73)
0.03
...median [IQR]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
3.00 [2.00, 4.00]
2.00 [1.00, 4.00]
3.00 [1.00, 6.00]
3.00 [1.00, 6.00]
2.79 (2.71)
2.59 (2.73)
0.07
Frailty Score (mean): Empirical Version 365 days, 
...mean (sd)
0.18 (0.07)
0.17 (0.07)
0.20 (0.06)
0.19 (0.06)
0.24 (0.08)
0.25 (0.08)
0.22 (0.07)
0.22 (0.07)
0.00
...median [IQR]
0.17 [0.13, 0.22]
0.16 [0.12, 0.21]
0.18 [0.15, 0.22]
0.18 [0.15, 0.21]
0.23 [0.19, 0.29]
0.23 [0.19, 0.29]
0.21 (0.07)
0.21 (0.07)
0.00
Healthcare Utilization
Any hospitalization; n (%)
31,029 (26.4%)
6,773 (22.8%)
38,526 (30.9%)
11,231 (25.9%)
85,357 (27.9%)
27,777 (26.8%)
154,912 (28.2%)
45,781 (25.9%)
0.05
Any hospitalization within prior 30 days; n (%)
14,219 (12.1%)
2,902 (9.8%)
16,906 (13.6%)
4,526 (10.5%)
33,515 (10.9%)
10,979 (10.6%)
64,640 (11.8%)
18,407 (10.4%)
0.04
Any hospitalization during prior 31-180 days; n (%)
19,490 (16.6%)
4,538 (15.2%)
24,550 (19.7%)
7,488 (17.3%)
60,385 (19.7%)
19,677 (19.0%)
104,425 (19.0%)
31,703 (17.9%)
0.03
Endocrinologist Visit; n (%)
7,995 (6.8%)
3,571 (12.0%)
8,438 (6.8%)
5,272 (12.2%)
25,598 (8.4%)
13,439 (13.0%)
42,031 (7.7%)
22,282 (12.6%)
-0.16
Endocrinologist Visit (30 days prior); n (%)
4,658 (4.0%)
2,186 (7.3%)
5,059 (4.1%)
3,405 (7.9%)
13,779 (4.5%)
7,806 (7.5%)
23,496 (4.3%)
13,397 (7.6%)
-0.14
Endocrinologist Visit (31 to 180 days prior); n (%)
5,356 (4.6%)
2,429 (8.2%)
5,416 (4.3%)
3,438 (7.9%)
18,906 (6.2%)
9,468 (9.1%)
29,678 (5.4%)
15,335 (8.7%)
-0.13
Internal medicine/family medicine visits; n (%)
102,084 (86.7%)
25,865 (86.9%)
102,764 (82.5%)
36,903 (85.2%)
266,343 (87.0%)
90,264 (87.1%)
471,191 (85.9%)
153,032 (86.6%)
-0.02
Internal medicine/family medicine visits (30 days prior) ; 
n (%)
76,112 (64.7%)
19,520 (65.6%)
74,503 (59.8%)
26,903 (62.1%)
188,745 (61.6%)
65,647 (63.3%)
339,360 (61.9%)
112,070 (63.4%)
-0.03
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Internal medicine/family medicine visits (31 to 180 days 
prior) ; n (%)
89,538 (76.1%)
23,378 (78.6%)
89,891 (72.1%)
32,962 (76.1%)
237,761 (77.6%)
81,893 (79.0%)
417,190 (76.0%)
138,233 (78.2%)
-0.05
Cardiologist visit; n (%)
64,077 (54.4%)
16,806 (56.5%)
57,020 (45.8%)
21,383 (49.4%)
183,503 (59.9%)
63,025 (60.8%)
304,600 (55.5%)
101,214 (57.3%)
-0.04
Number of Cardiologist visits (30 days prior); n (%)
27,683 (23.5%)
6,944 (23.3%)
22,417 (18.0%)
8,351 (19.3%)
72,663 (23.7%)
25,568 (24.7%)
122,763 (22.4%)
40,863 (23.1%)
-0.02
Number of Cardiologist visits (31 to 180 days prior); n (%)
52,002 (44.2%)
14,115 (47.4%)
48,005 (38.5%)
18,177 (42.0%)
157,097 (51.3%)
54,253 (52.3%)
257,104 (46.9%)
86,545 (49.0%)
-0.04
Electrocardiogram ; n (%)
60,155 (51.1%)
15,717 (52.8%)
62,346 (50.0%)
22,093 (51.0%)
168,509 (55.0%)
59,129 (57.0%)
291,010 (53.0%)
96,939 (54.8%)
-0.04
Use of glucose test strips; n (%)
5,000 (4.2%)
1,539 (5.2%)
4,866 (3.9%)
2,007 (4.6%)
12,883 (4.2%)
4,655 (4.5%)
22,749 (4.1%)
8,201 (4.6%)
-0.02
Dialysis; n (%)
775 (0.7%)
122 (0.4%)
849 (0.7%)
225 (0.5%)
4,837 (1.6%)
1,196 (1.2%)
6,461 (1.2%)
1,543 (0.9%)
0.03
Naive new user v8 ; n (%)
49,305 (41.9%)
10,730 (36.1%)
51,732 (41.5%)
15,574 (36.0%)
110,966 (36.2%)
33,036 (31.9%)
212,003 (38.6%)
59,340 (33.6%)
0.10
N antidiabetic drugs at index date  
...mean (sd)
1.52 (0.62)
1.68 (0.66)
1.51 (0.63)
1.67 (0.66)
1.47 (0.60)
1.66 (0.66)
1.49 (0.61)
1.67 (0.66)
-0.28
...median [IQR]
1.00 [1.00, 2.00]
2.00 [1.00, 2.00]
1.00 [1.00, 2.00]
2.00 [1.00, 2.00]
1.00 [1.00, 2.00]
2.00 [1.00, 2.00]
1.00 (0.61)
2.00 (0.66)
-1.57
number of different/distinct medication prescriptions
...mean (sd)
10.39 (5.16)
11.20 (5.60)
10.53 (5.16)
10.84 (5.32)
10.98 (5.02)
11.85 (5.55)
10.75 (5.08)
11.49 (5.50)
-0.14
...median [IQR]
10.00 [7.00, 13.00]
10.00 [7.00, 14.00]
10.00 [7.00, 13.00]
10.00 [7.00, 14.00]
10.00 [7.00, 14.00]11.00 [8.00, 15.00]
10.00 (5.08)
10.59 (5.50)
-0.11
Number of Hospitalizations
...mean (sd)
0.35 (0.68)
0.30 (0.65)
0.39 (0.68)
0.32 (0.63)
0.40 (0.77)
0.39 (0.77)
0.39 (0.73)
0.36 (0.72)
0.04
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (0.73)
0.00 (0.72)
0.00
Number of hospital days
...mean (sd)
2.18 (6.04)
1.95 (6.01)
2.59 (7.05)
2.15 (6.52)
2.67 (6.96)
2.72 (7.33)
2.55 (6.79)
2.45 (6.93)
0.01
...median [IQR]
0.00 [0.00, 2.00]
0.00 [0.00, 0.00]
0.00 [0.00, 3.00]
0.00 [0.00, 2.00]
0.00 [0.00, 3.00]
0.00 [0.00, 3.00]
0.00 (6.79)
0.00 (6.93)
0.00
Number of Emergency Department (ED) visits 
...mean (sd)
0.76 (1.72)
0.74 (1.78)
0.59 (2.49)
0.49 (2.23)
1.03 (2.00)
0.98 (2.10)
0.87 (2.07)
0.82 (2.08)
0.02
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 2.00]
0.00 [0.00, 2.00]
0.00 (2.07)
0.00 (2.08)
0.00
Number of Office visits
...mean (sd)
5.74 (4.68)
6.30 (4.81)
6.02 (5.08)
6.41 (4.84)
6.56 (5.19)
7.04 (5.47)
6.26 (5.06)
6.76 (5.21)
-0.10
...median [IQR]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
5.00 [3.00, 9.00] 6.00 [3.00, 10.00]
5.00 (5.06)
5.59 (5.21)
-0.11
Number of Endocrinologist visits
...mean (sd)
0.31 (1.81)
0.59 (2.52)
0.31 (1.79)
0.62 (2.88)
0.46 (2.57)
0.77 (3.65)
0.39 (2.26)
0.70 (3.30)
-0.11
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (2.26)
0.00 (3.30)
0.00
Number of internal medicine/family medicine visits
...mean (sd)
11.67 (16.93)
11.94 (16.11)
8.17 (12.67)
8.75 (12.69)
10.19 (12.62)
10.90 (13.48)
10.05 (13.67)
10.55 (13.77)
-0.04
...median [IQR]
7.00 [2.00, 15.00]
7.00 [3.00, 15.00]
5.00 [1.00, 10.00]
5.00 [2.00, 11.00]
6.00 [2.00, 14.00] 7.00 [3.00, 15.00]
5.99 (13.67)
6.51 (13.77)
-0.04
Number of Cardiologist visits
...mean (sd)
3.58 (6.52)
3.72 (6.54)
2.48 (4.91)
2.73 (5.15)
3.71 (6.44)
3.95 (6.94)
3.40 (6.14)
3.61 (6.48)
-0.03
...median [IQR]
1.00 [0.00, 4.00]
1.00 [0.00, 5.00]
0.00 [0.00, 3.00]
0.00 [0.00, 3.00]
1.00 [0.00, 5.00]
1.00 [0.00, 5.00]
0.77 (6.14)
0.75 (6.48)
0.00
Number electrocardiograms received 
...mean (sd)
1.28 (2.15)
1.32 (2.27)
1.08 (1.70)
1.08 (1.70)
1.38 (2.03)
1.43 (2.07)
1.29 (1.99)
1.33 (2.02)
-0.02
...median [IQR]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
1.00 [0.00, 1.00]
1.00 [0.00, 1.00]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
1.00 (1.99)
1.00 (2.02)
0.00
Number of HbA1c tests ordered
...mean (sd)
1.04 (0.93)
1.21 (0.97)
0.69 (0.87)
0.83 (0.92)
1.23 (0.93)
1.36 (1.00)
1.07 (0.92)
1.20 (0.98)
-0.14
...median [IQR]
1.00 [0.00, 2.00]
1.00 [1.00, 2.00]
0.00 [0.00, 1.00]
1.00 [0.00, 1.00]
1.00 [1.00, 2.00]
1.00 [1.00, 2.00]
0.77 (0.92)
1.00 (0.98)
-0.24
Number of glucose tests ordered
...mean (sd)
0.61 (3.51)
0.82 (5.19)
0.44 (1.85)
0.49 (1.71)
0.49 (1.24)
0.56 (1.29)
0.50 (2.07)
0.59 (2.50)
-0.04
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (2.07)
0.00 (2.50)
0.00
Number of lipid tests ordered
...mean (sd)
0.87 (0.99)
1.04 (1.08)
0.64 (1.15)
0.78 (1.21)
0.92 (0.89)
1.06 (0.95)
0.85 (0.98)
0.99 (1.04)
-0.14
...median [IQR]
1.00 [0.00, 1.00]
1.00 [0.00, 2.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
1.00 [0.00, 1.00]
1.00 [0.00, 2.00]
0.77 (0.98)
0.75 (1.04)
0.02
Number of creatinine tests ordered
...mean (sd)
0.10 (0.50)
0.10 (0.46)
0.12 (0.57)
0.09 (0.44)
0.15 (0.62)
0.13 (0.54)
0.13 (0.58)
0.12 (0.50)
0.02
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (0.58)
0.00 (0.50)
0.00
Number of BUN tests ordered
...mean (sd)
0.07 (0.56)
0.07 (0.50)
0.09 (0.57)
0.07 (0.44)
0.11 (0.57)
0.09 (0.49)
0.10 (0.57)
0.08 (0.48)
0.04
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (0.57)
0.00 (0.48)
0.00
Number of tests for microalbuminuria
...mean (sd)
0.55 (1.04)
0.66 (1.15)
0.31 (0.79)
0.40 (0.92)
0.38 (0.72)
0.43 (0.77)
0.40 (0.81)
0.46 (0.88)
-0.07
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (0.81)
0.00 (0.88)
0.00
Total N distinct ICD9/ICD10 diagnoses at the 3rd digit 
level 
...mean (sd)
6.83 (9.63)
7.34 (10.38)
3.54 (7.30)
3.64 (7.42)
9.10 (11.55)
9.58 (11.86)
7.35 (10.32)
7.75 (10.68)
-0.04
...median [IQR]
4.00 [0.00, 10.00]
4.00 [0.00, 11.00]
0.00 [0.00, 4.00]
0.00 [0.00, 4.00]
5.00 [0.00, 14.00] 5.00 [0.00, 15.00]
3.65 (10.32)
3.61 (10.68)
0.00
Use of thiazide; n (%)
14,035 (11.9%)
3,360 (11.3%)
14,093 (11.3%)
4,532 (10.5%)
38,970 (12.7%)
12,451 (12.0%)
67,098 (12.2%)
20,343 (11.5%)
0.02
Use of beta blockers; n (%)
67,251 (57.1%)
16,807 (56.5%)
73,540 (59.0%)
25,059 (57.9%)
189,722 (61.9%)
63,832 (61.6%)
330,513 (60.2%)
105,698 (59.8%)
0.01
Use of calcium channel blockers; n (%)
36,173 (30.7%)
9,328 (31.3%)
37,784 (30.3%)
12,933 (29.9%)
108,802 (35.5%)
37,734 (36.4%)
182,759 (33.3%)
59,995 (33.9%)
-0.01
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Variable
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
Reference- 2nd 
Generation SUs
Exposure- Sitagliptin
St. Diff.
Number of patients
29727
29727
42600
42600
102411
102411                                        174,738                                        174,738 
Age
...mean (sd)
69.12 (9.30)
69.12 (9.34)
66.33 (10.33)
66.30 (10.16)
75.64 (7.48)
75.65 (7.46)
72.26 (8.57)
72.26 (8.52)
0.00
...median [IQR]
69.00 [62.00, 76.00]
69.00 [62.00, 76.00]
64.00 [58.00, 74.00]
64.00 [59.00, 74.00]
75.00 [69.00, 81.00]
75.00 [70.00, 81.00]
71.30 (8.57)
71.30 (8.52)
0.00
Age categories
...18 - 54; n (%)
2,134 (7.2%)
2,058 (6.9%)
4,943 (11.6%)
4,689 (11.0%)
0 (0.0%)
0 (0.0%)
7,077 (4.1%)
6,747 (3.9%)
0.01
...55 - 64; n (%)
7,091 (23.9%)
7,372 (24.8%)
17,575 (41.3%)
17,810 (41.8%)
1,639 (1.6%)
1,663 (1.6%)
26,305 (15.1%)
26,845 (15.4%)
-0.01
...65 - 74; n (%)
11,421 (38.4%)
11,335 (38.1%)
9,824 (23.1%)
10,211 (24.0%)
48,995 (47.8%)
48,760 (47.6%)
70,240 (40.2%)
70,306 (40.2%)
0.00
...>= 75; n (%)
9,081 (30.5%)
8,962 (30.1%)
10,258 (24.1%)
9,890 (23.2%)
51,777 (50.6%)
51,988 (50.8%)
71,116 (40.7%)
70,840 (40.5%)
0.00
Gender- 
...Males; n (%)
16,707 (56.2%)
16,770 (56.4%)
26,043 (61.1%)
26,160 (61.4%)
48,955 (47.8%)
49,246 (48.1%)
91,705 (52.5%)
92,176 (52.8%)
-0.01
...Females; n (%)
13,020 (43.8%)
12,957 (43.6%)
16,557 (38.9%)
16,440 (38.6%)
53,456 (52.2%)
53,165 (51.9%)
83,033 (47.5%)
82,562 (47.2%)
0.01
Race without zero category
...White; n (%)
N/A
N/A
N/A
N/A
78,029 (76.2%)
78,110 (76.3%)
78,029 (76.2%)
78,110 (76.3%)
0.00
...Black; n (%)
N/A
N/A
N/A
N/A
11,990 (11.7%)
11,921 (11.6%)
11,990 (11.7%)
11,921 (11.6%)
0.00
...Asian; n (%)
N/A
N/A
N/A
N/A
4,049 (4.0%)
4,135 (4.0%)
4,049 (4.0%)
4,135 (4.0%)
0.00
...Hispanic; n (%)
N/A
N/A
N/A
N/A
4,455 (4.4%)
4,419 (4.3%)
4,455 (4.4%)
4,419 (4.3%)
0.00
...North American Native; n (%)
N/A
N/A
N/A
N/A
507 (0.5%)
527 (0.5%)
507 (0.5%)
527 (0.5%)
0.00
...Other/Unknown; n (%)
N/A
N/A
N/A
N/A
3,381 (3.3%)
3,299 (3.2%)
3,381 (3.3%)
3,299 (3.2%)
0.01
Region-   (lumping missing&other category with 
West)
...Northeast; n (%)
4,282 (14.4%)
4,214 (14.2%)
9,061 (21.3%)
9,017 (21.2%)
23,934 (23.4%)
23,883 (23.3%)
37,277 (21.3%)
37,114 (21.2%)
0.00
...South; n (%)
14,991 (50.4%)
15,045 (50.6%)
11,460 (26.9%)
11,433 (26.8%)
42,802 (41.8%)
42,665 (41.7%)
69,253 (39.6%)
69,143 (39.6%)
0.00
...Midwest; n (%)
4,983 (16.8%)
5,055 (17.0%)
17,261 (40.5%)
17,306 (40.6%)
19,090 (18.6%)
19,020 (18.6%)
41,334 (23.7%)
41,381 (23.7%)
0.00
...West; n (%)
5,471 (18.4%)
5,413 (18.2%)
4,420 (10.4%)
4,425 (10.4%)
16,585 (16.2%)
16,843 (16.4%)
26,476 (15.2%)
26,681 (15.3%)
0.00
...Unknown+missing; n (%)
N/A
N/A
398 (0.9%)
419 (1.0%)
N/A
N/A
398 (0.9%)
419 (1.0%)
-0.01
CV Covariates
Ischemic heart disease; n (%)
19,747 (66.4%)
19,742 (66.4%)
27,261 (64.0%)
27,300 (64.1%)
69,177 (67.5%)
69,239 (67.6%)
116,185 (66.5%)
116,281 (66.5%)
0.00
Acute MI; n (%)
1,484 (5.0%)
1,555 (5.2%)
2,434 (5.7%)
2,420 (5.7%)
4,732 (4.6%)
4,708 (4.6%)
8,650 (5.0%)
8,683 (5.0%)
0.00
ACS/unstable angina; n (%)
1,542 (5.2%)
1,607 (5.4%)
2,448 (5.7%)
2,483 (5.8%)
4,573 (4.5%)
4,651 (4.5%)
8,563 (4.9%)
8,741 (5.0%)
0.00
Old MI; n (%)
2,812 (9.5%)
2,811 (9.5%)
2,027 (4.8%)
2,046 (4.8%)
9,882 (9.6%)
9,759 (9.5%)
14,721 (8.4%)
14,616 (8.4%)
0.00
Stable angina; n (%)
2,591 (8.7%)
2,601 (8.7%)
3,005 (7.1%)
2,982 (7.0%)
8,120 (7.9%)
8,137 (7.9%)
13,716 (7.8%)
13,720 (7.9%)
0.00
Coronary atherosclerosis and other forms of chronic 
ischemic heart disease; n (%)
18,771 (63.1%)
18,846 (63.4%)
26,077 (61.2%)
26,181 (61.5%)
66,512 (64.9%)
66,608 (65.0%)
111,360 (63.7%)
111,635 (63.9%)
0.00
Other atherosclerosis with ICD10  ; n (%)
790 (2.7%)
858 (2.9%)
1,074 (2.5%)
1,092 (2.6%)
3,628 (3.5%)
3,676 (3.6%)
5,492 (3.1%)
5,626 (3.2%)
-0.01
Previous cardiac procedure (CABG or PTCA or Stent) 
v4; n (%)
1,030 (3.5%)
1,123 (3.8%)
2,130 (5.0%)
2,269 (5.3%)
2,370 (2.3%)
2,554 (2.5%)
5,530 (3.2%)
5,946 (3.4%)
-0.01
History of CABG or PTCA; n (%)
4,453 (15.0%)
4,624 (15.6%)
3,519 (8.3%)
3,414 (8.0%)
19,111 (18.7%)
18,973 (18.5%)
27,083 (15.5%)
27,011 (15.5%)
0.00
Any stroke; n (%)
6,435 (21.6%)
6,459 (21.7%)
8,532 (20.0%)
8,599 (20.2%)
25,540 (24.9%)
25,325 (24.7%)
40,507 (23.2%)
40,383 (23.1%)
0.00
Ischemic stroke (w and w/o mention of cerebral 
infarction); n (%)
6,395 (21.5%)
6,429 (21.6%)
8,476 (19.9%)
8,544 (20.1%)
25,344 (24.7%)
25,140 (24.5%)
40,215 (23.0%)
40,113 (23.0%)
0.00
Hemorrhagic stroke; n (%)
153 (0.5%)
181 (0.6%)
267 (0.6%)
269 (0.6%)
731 (0.7%)
734 (0.7%)
1,151 (0.7%)
1,184 (0.7%)
0.00
TIA; n (%)
1,271 (4.3%)
1,290 (4.3%)
1,638 (3.8%)
1,664 (3.9%)
5,051 (4.9%)
5,085 (5.0%)
7,960 (4.6%)
8,039 (4.6%)
0.00
Other cerebrovascular disease; n (%)
1,504 (5.1%)
1,522 (5.1%)
1,619 (3.8%)
1,534 (3.6%)
6,569 (6.4%)
6,547 (6.4%)
9,692 (5.5%)
9,603 (5.5%)
0.00
Late effects of cerebrovascular disease; n (%)
1,537 (5.2%)
1,504 (5.1%)
1,428 (3.4%)
1,404 (3.3%)
6,846 (6.7%)
6,639 (6.5%)
9,811 (5.6%)
9,547 (5.5%)
0.00
Cerebrovascular procedure; n (%)
121 (0.4%)
95 (0.3%)
185 (0.4%)
183 (0.4%)
347 (0.3%)
366 (0.4%)
653 (0.4%)
644 (0.4%)
0.00
Heart failure (CHF); n (%)
5,804 (19.5%)
5,818 (19.6%)
6,286 (14.8%)
6,163 (14.5%)
24,326 (23.8%)
24,239 (23.7%)
36,416 (20.8%)
36,220 (20.7%)
0.00
Peripheral Vascular Disease (PVD) or PVD Surgery ; n 
(%)
4,609 (15.5%)
4,584 (15.4%)
4,885 (11.5%)
4,787 (11.2%)
22,088 (21.6%)
22,005 (21.5%)
31,582 (18.1%)
31,376 (18.0%)
0.00
Atrial fibrillation; n (%)
4,253 (14.3%)
4,299 (14.5%)
5,058 (11.9%)
5,049 (11.9%)
21,032 (20.5%)
20,931 (20.4%)
30,343 (17.4%)
30,279 (17.3%)
0.00
Other cardiac dysrhythmia; n (%)
5,074 (17.1%)
5,103 (17.2%)
5,630 (13.2%)
5,736 (13.5%)
23,178 (22.6%)
23,020 (22.5%)
33,882 (19.4%)
33,859 (19.4%)
0.00
Cardiac conduction disorders; n (%)
1,629 (5.5%)
1,675 (5.6%)
1,733 (4.1%)
1,742 (4.1%)
8,051 (7.9%)
7,876 (7.7%)
11,413 (6.5%)
11,293 (6.5%)
0.00
Other CVD; n (%)
7,186 (24.2%)
7,142 (24.0%)
9,007 (21.1%)
9,016 (21.2%)
29,402 (28.7%)
29,351 (28.7%)
45,595 (26.1%)
45,509 (26.0%)
0.00
Diabetes-related complications
Diabetic retinopathy; n (%)
1,918 (6.5%)
1,899 (6.4%)
1,668 (3.9%)
1,667 (3.9%)
6,863 (6.7%)
6,927 (6.8%)
10,449 (6.0%)
10,493 (6.0%)
0.00
Diabetes with other ophthalmic manifestations; n 
(%)
167 (0.6%)
145 (0.5%)
1,278 (3.0%)
1,276 (3.0%)
2,810 (2.7%)
2,793 (2.7%)
4,255 (2.4%)
4,214 (2.4%)
0.00
Optum
 PS-matched
MarketScan
Medicare
POOLED
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Retinal detachment, vitreous hemorrhage, 
vitrectomy; n (%)
135 (0.5%)
149 (0.5%)
133 (0.3%)
166 (0.4%)
425 (0.4%)
464 (0.5%)
693 (0.4%)
779 (0.4%)
0.00
Retinal laser coagulation therapy; n (%)
182 (0.6%)
173 (0.6%)
260 (0.6%)
284 (0.7%)
580 (0.6%)
607 (0.6%)
1,022 (0.6%)
1,064 (0.6%)
0.00
Occurrence of Diabetic Neuropathy  ; n (%)
5,913 (19.9%)
5,840 (19.6%)
4,816 (11.3%)
4,778 (11.2%)
22,008 (21.5%)
21,921 (21.4%)
32,737 (18.7%)
32,539 (18.6%)
0.00
Occurrence of diabetic nephropathy  with ICD10 ; n 
(%)
4,521 (15.2%)
4,484 (15.1%)
2,463 (5.8%)
2,421 (5.7%)
11,652 (11.4%)
11,510 (11.2%)
18,636 (10.7%)
18,415 (10.5%)
0.01
Hypoglycemia ; n (%)
1,110 (3.7%)
1,077 (3.6%)
1,283 (3.0%)
1,306 (3.1%)
4,201 (4.1%)
4,170 (4.1%)
6,594 (3.8%)
6,553 (3.8%)
0.00
Hyperglycemia; n (%)
1,789 (6.0%)
1,795 (6.0%)
1,763 (4.1%)
1,772 (4.2%)
7,494 (7.3%)
7,515 (7.3%)
11,046 (6.3%)
11,082 (6.3%)
0.00
Disorders of fluid electrolyte and acid-base balance; n 
(%)
3,986 (13.4%)
4,093 (13.8%)
3,893 (9.1%)
3,929 (9.2%)
17,450 (17.0%)
17,131 (16.7%)
25,329 (14.5%)
25,153 (14.4%)
0.00
Diabetic ketoacidosis; n (%)
3 (0.0%)
4 (0.0%)
2 (0.0%)
6 (0.0%)
31 (0.0%)
29 (0.0%)
036 (0.0%)
039 (0.0%)
#DIV/0!
Hyperosmolar hyperglycemic nonketotic syndrome 
(HONK); n (%)
180 (0.6%)
186 (0.6%)
201 (0.5%)
207 (0.5%)
751 (0.7%)
762 (0.7%)
1,132 (0.6%)
1,155 (0.7%)
-0.01
Diabetes with peripheral circulatory disorders with 
ICD-10  ; n (%)
2,922 (9.8%)
2,927 (9.8%)
2,271 (5.3%)
2,171 (5.1%)
11,073 (10.8%)
11,106 (10.8%)
16,266 (9.3%)
16,204 (9.3%)
0.00
Diabetic Foot; n (%)
1,120 (3.8%)
1,127 (3.8%)
1,347 (3.2%)
1,292 (3.0%)
4,785 (4.7%)
4,658 (4.5%)
7,252 (4.2%)
7,077 (4.1%)
0.01
Gangrene ; n (%)
222 (0.7%)
213 (0.7%)
260 (0.6%)
254 (0.6%)
663 (0.6%)
639 (0.6%)
1,145 (0.7%)
1,106 (0.6%)
0.01
Lower extremity amputation; n (%)
571 (1.9%)
560 (1.9%)
437 (1.0%)
403 (0.9%)
1,712 (1.7%)
1,718 (1.7%)
2,720 (1.6%)
2,681 (1.5%)
0.01
Osteomyelitis; n (%)
403 (1.4%)
399 (1.3%)
519 (1.2%)
457 (1.1%)
1,273 (1.2%)
1,267 (1.2%)
2,195 (1.3%)
2,123 (1.2%)
0.01
Skin infections ; n (%)
2,301 (7.7%)
2,363 (7.9%)
3,071 (7.2%)
3,038 (7.1%)
10,296 (10.1%)
10,122 (9.9%)
15,668 (9.0%)
15,523 (8.9%)
0.00
Erectile dysfunction; n (%)
775 (2.6%)
802 (2.7%)
888 (2.1%)
881 (2.1%)
2,403 (2.3%)
2,380 (2.3%)
4,066 (2.3%)
4,063 (2.3%)
0.00
Diabetes with unspecified complication; n (%)
1,863 (6.3%)
1,849 (6.2%)
1,859 (4.4%)
1,814 (4.3%)
6,426 (6.3%)
6,351 (6.2%)
10,148 (5.8%)
10,014 (5.7%)
0.00
Diabetes mellitus without mention of complications; 
n (%)
27,552 (92.7%)
27,521 (92.6%)
40,513 (95.1%)
40,470 (95.0%)
97,729 (95.4%)
97,734 (95.4%)
165,794 (94.9%)
165,725 (94.8%)
0.00
Hypertension: 1 inpatient or 2 outpatient claims 
within 365 days; n (%)
26,771 (90.1%)
26,773 (90.1%)
31,437 (73.8%)
31,407 (73.7%)
97,195 (94.9%)
97,173 (94.9%)
155,403 (88.9%)
155,353 (88.9%)
0.00
Hyperlipidemia ; n (%)
23,855 (80.2%)
23,797 (80.1%)
25,697 (60.3%)
25,671 (60.3%)
84,137 (82.2%)
84,130 (82.1%)
133,689 (76.5%)
133,598 (76.5%)
0.00
Edema; n (%)
3,092 (10.4%)
3,153 (10.6%)
2,925 (6.9%)
2,853 (6.7%)
15,151 (14.8%)
15,070 (14.7%)
21,168 (12.1%)
21,076 (12.1%)
0.00
Renal Dysfunction (non-diabetic) ; n (%)
8,526 (28.7%)
8,686 (29.2%)
7,501 (17.6%)
7,507 (17.6%)
33,142 (32.4%)
32,819 (32.0%)
49,169 (28.1%)
49,012 (28.0%)
0.00
Occurrence of acute renal disease ; n (%)
2,238 (7.5%)
2,298 (7.7%)
2,338 (5.5%)
2,329 (5.5%)
9,092 (8.9%)
8,926 (8.7%)
13,668 (7.8%)
13,553 (7.8%)
0.00
Occurrence of chronic renal insufficiency; n (%)
6,518 (21.9%)
6,621 (22.3%)
4,835 (11.3%)
4,740 (11.1%)
25,668 (25.1%)
25,291 (24.7%)
37,021 (21.2%)
36,652 (21.0%)
0.00
Chronic kidney disease ; n (%)
6,285 (21.1%)
6,406 (21.5%)
4,651 (10.9%)
4,584 (10.8%)
24,388 (23.8%)
24,047 (23.5%)
35,324 (20.2%)
35,037 (20.1%)
0.00
CKD Stage 3-4; n (%)
4,145 (13.9%)
4,161 (14.0%)
2,852 (6.7%)
2,859 (6.7%)
15,873 (15.5%)
15,739 (15.4%)
22,870 (13.1%)
22,759 (13.0%)
0.00
Occurrence of hypertensive nephropathy; n (%)
3,411 (11.5%)
3,468 (11.7%)
2,193 (5.1%)
2,217 (5.2%)
13,686 (13.4%)
13,414 (13.1%)
19,290 (11.0%)
19,099 (10.9%)
0.00
Occurrence of miscellaneous renal insufficiency ; n 
(%)
2,817 (9.5%)
2,845 (9.6%)
2,640 (6.2%)
2,693 (6.3%)
11,951 (11.7%)
11,930 (11.6%)
17,408 (10.0%)
17,468 (10.0%)
0.00
Glaucoma or cataracts ; n (%)
5,943 (20.0%)
6,088 (20.5%)
7,023 (16.5%)
7,005 (16.4%)
26,942 (26.3%)
27,628 (27.0%)
39,908 (22.8%)
40,721 (23.3%)
-0.01
Cellulitis or abscess of toe; n (%)
631 (2.1%)
580 (2.0%)
586 (1.4%)
604 (1.4%)
2,291 (2.2%)
2,264 (2.2%)
3,508 (2.0%)
3,448 (2.0%)
0.00
Foot ulcer; n (%)
1,138 (3.8%)
1,125 (3.8%)
1,380 (3.2%)
1,322 (3.1%)
4,839 (4.7%)
4,694 (4.6%)
7,357 (4.2%)
7,141 (4.1%)
0.01
Bladder stones; n (%)
50 (0.2%)
47 (0.2%)
57 (0.1%)
57 (0.1%)
280 (0.3%)
257 (0.3%)
387 (0.2%)
361 (0.2%)
0.00
Kidney stones; n (%)
859 (2.9%)
875 (2.9%)
1,050 (2.5%)
1,089 (2.6%)
3,806 (3.7%)
3,735 (3.6%)
5,715 (3.3%)
5,699 (3.3%)
0.00
Urinary tract infections (UTIs); n (%)
3,935 (13.2%)
3,948 (13.3%)
3,824 (9.0%)
3,849 (9.0%)
22,033 (21.5%)
21,918 (21.4%)
29,792 (17.0%)
29,715 (17.0%)
0.00
Dipstick urinalysis; n (%)
11,544 (38.8%)
12,011 (40.4%)
13,540 (31.8%)
13,806 (32.4%)
48,563 (47.4%)
49,255 (48.1%)
73,647 (42.1%)
75,072 (43.0%)
-0.02
Non-dipstick urinalysis; n (%)
10,656 (35.8%)
10,724 (36.1%)
10,365 (24.3%)
10,251 (24.1%)
36,142 (35.3%)
36,237 (35.4%)
57,163 (32.7%)
57,212 (32.7%)
0.00
Urine function test; n (%)
1,027 (3.5%)
963 (3.2%)
1,439 (3.4%)
1,533 (3.6%)
4,908 (4.8%)
5,253 (5.1%)
7,374 (4.2%)
7,749 (4.4%)
-0.01
Cytology; n (%)
512 (1.7%)
506 (1.7%)
942 (2.2%)
1,019 (2.4%)
2,366 (2.3%)
2,440 (2.4%)
3,820 (2.2%)
3,965 (2.3%)
-0.01
Cystos; n (%)
649 (2.2%)
654 (2.2%)
1,037 (2.4%)
1,086 (2.5%)
3,050 (3.0%)
2,976 (2.9%)
4,736 (2.7%)
4,716 (2.7%)
0.00
Other Covariates
Liver disease; n (%)
1,450 (4.9%)
1,449 (4.9%)
1,712 (4.0%)
1,706 (4.0%)
5,633 (5.5%)
5,716 (5.6%)
8,795 (5.0%)
8,871 (5.1%)
0.00
Osteoarthritis; n (%)
5,746 (19.3%)
5,678 (19.1%)
5,761 (13.5%)
5,728 (13.4%)
29,354 (28.7%)
29,454 (28.8%)
40,861 (23.4%)
40,860 (23.4%)
0.00
Other arthritis, arthropathies and musculoskeletal 
pain; n (%)
13,225 (44.5%)
13,184 (44.4%)
15,938 (37.4%)
15,775 (37.0%)
57,375 (56.0%)
57,366 (56.0%)
86,538 (49.5%)
86,325 (49.4%)
0.00
Dorsopathies; n (%)
7,645 (25.7%)
7,663 (25.8%)
8,975 (21.1%)
9,034 (21.2%)
33,337 (32.6%)
33,387 (32.6%)
49,957 (28.6%)
50,084 (28.7%)
0.00
Fractures; n (%)
1,335 (4.5%)
1,325 (4.5%)
1,729 (4.1%)
1,680 (3.9%)
6,526 (6.4%)
6,427 (6.3%)
9,590 (5.5%)
9,432 (5.4%)
0.00
Falls ; n (%)
1,648 (5.5%)
1,676 (5.6%)
671 (1.6%)
669 (1.6%)
7,999 (7.8%)
7,998 (7.8%)
10,318 (5.9%)
10,343 (5.9%)
0.00
Osteoporosis; n (%)
2,026 (6.8%)
1,959 (6.6%)
1,826 (4.3%)
1,829 (4.3%)
11,401 (11.1%)
11,491 (11.2%)
15,253 (8.7%)
15,279 (8.7%)
0.00
Hyperthyroidism; n (%)
258 (0.9%)
273 (0.9%)
254 (0.6%)
269 (0.6%)
1,392 (1.4%)
1,291 (1.3%)
1,904 (1.1%)
1,833 (1.0%)
0.01
Hypothyroidism ; n (%)
5,006 (16.8%)
5,007 (16.8%)
4,596 (10.8%)
4,556 (10.7%)
18,859 (18.4%)
18,715 (18.3%)
28,461 (16.3%)
28,278 (16.2%)
0.00
Other disorders of thyroid gland ; n (%)
1,304 (4.4%)
1,297 (4.4%)
1,405 (3.3%)
1,511 (3.5%)
5,386 (5.3%)
5,644 (5.5%)
8,095 (4.6%)
8,452 (4.8%)
-0.01
Depression; n (%)
3,342 (11.2%)
3,384 (11.4%)
3,165 (7.4%)
3,203 (7.5%)
16,712 (16.3%)
16,568 (16.2%)
23,219 (13.3%)
23,155 (13.3%)
0.00
Anxiety; n (%)
2,701 (9.1%)
2,670 (9.0%)
2,053 (4.8%)
2,071 (4.9%)
12,712 (12.4%)
12,566 (12.3%)
17,466 (10.0%)
17,307 (9.9%)
0.00
Sleep_Disorder; n (%)
3,198 (10.8%)
3,169 (10.7%)
4,986 (11.7%)
4,912 (11.5%)
11,466 (11.2%)
11,493 (11.2%)
19,650 (11.2%)
19,574 (11.2%)
0.00
Dementia; n (%)
2,224 (7.5%)
2,267 (7.6%)
1,970 (4.6%)
1,919 (4.5%)
14,941 (14.6%)
14,723 (14.4%)
19,135 (11.0%)
18,909 (10.8%)
0.01
Delirium; n (%)
884 (3.0%)
914 (3.1%)
984 (2.3%)
996 (2.3%)
5,202 (5.1%)
5,036 (4.9%)
7,070 (4.0%)
6,946 (4.0%)
0.00
Psychosis; n (%)
582 (2.0%)
615 (2.1%)
598 (1.4%)
593 (1.4%)
4,032 (3.9%)
3,917 (3.8%)
5,212 (3.0%)
5,125 (2.9%)
0.01
Obesity; n (%)
5,273 (17.7%)
5,251 (17.7%)
4,452 (10.5%)
4,430 (10.4%)
16,002 (15.6%)
15,920 (15.5%)
25,727 (14.7%)
25,601 (14.7%)
0.00
Overweight; n (%)
1,301 (4.4%)
1,275 (4.3%)
597 (1.4%)
604 (1.4%)
3,724 (3.6%)
3,738 (3.6%)
5,622 (3.2%)
5,617 (3.2%)
0.00
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Smoking; n (%)
4,679 (15.7%)
4,679 (15.7%)
3,092 (7.3%)
3,132 (7.4%)
19,687 (19.2%)
19,521 (19.1%)
27,458 (15.7%)
27,332 (15.6%)
0.00
Alcohol abuse or dependence; n (%)
287 (1.0%)
287 (1.0%)
264 (0.6%)
266 (0.6%)
887 (0.9%)
899 (0.9%)
1,438 (0.8%)
1,452 (0.8%)
0.00
Drug abuse or dependence; n (%)
453 (1.5%)
473 (1.6%)
281 (0.7%)
259 (0.6%)
1,406 (1.4%)
1,440 (1.4%)
2,140 (1.2%)
2,172 (1.2%)
0.00
COPD; n (%)
4,606 (15.5%)
4,680 (15.7%)
4,833 (11.3%)
4,849 (11.4%)
19,771 (19.3%)
19,860 (19.4%)
29,210 (16.7%)
29,389 (16.8%)
0.00
Asthma; n (%)
2,066 (6.9%)
2,129 (7.2%)
2,217 (5.2%)
2,218 (5.2%)
8,593 (8.4%)
8,606 (8.4%)
12,876 (7.4%)
12,953 (7.4%)
0.00
Obstructive sleep apnea; n (%)
3,164 (10.6%)
3,100 (10.4%)
4,205 (9.9%)
4,193 (9.8%)
9,119 (8.9%)
9,049 (8.8%)
16,488 (9.4%)
16,342 (9.4%)
0.00
Pneumonia; n (%)
1,627 (5.5%)
1,654 (5.6%)
2,255 (5.3%)
2,217 (5.2%)
7,732 (7.5%)
7,674 (7.5%)
11,614 (6.6%)
11,545 (6.6%)
0.00
Imaging; n (%)
146 (0.5%)
128 (0.4%)
101 (0.2%)
114 (0.3%)
500 (0.5%)
545 (0.5%)
747 (0.4%)
787 (0.5%)
-0.01
Diabetes Medications
DM Medications - AGIs; n (%)
96 (0.3%)
96 (0.3%)
136 (0.3%)
133 (0.3%)
411 (0.4%)
414 (0.4%)
643 (0.4%)
643 (0.4%)
0.00
DM Medications - Glitazones; n (%)
2,692 (9.1%)
2,696 (9.1%)
4,523 (10.6%)
4,386 (10.3%)
5,892 (5.8%)
5,851 (5.7%)
13,107 (7.5%)
12,933 (7.4%)
0.00
DM Medications - GLP-1 RA; n (%)
198 (0.7%)
190 (0.6%)
182 (0.4%)
187 (0.4%)
354 (0.3%)
332 (0.3%)
#VALUE!
#VALUE!
#VALUE!
DM Medications - Insulin; n (%)
5,880 (19.8%)
5,819 (19.6%)
6,527 (15.3%)
6,474 (15.2%)
22,926 (22.4%)
22,323 (21.8%)
35,333 (20.2%)
34,616 (19.8%)
0.01
DM Medications - Meglitinides; n (%)
577 (1.9%)
659 (2.2%)
1,311 (3.1%)
1,333 (3.1%)
2,582 (2.5%)
2,736 (2.7%)
4,470 (2.6%)
4,728 (2.7%)
-0.01
DM Medications - Metformin; n (%)
17,034 (57.3%)
17,021 (57.3%)
24,802 (58.2%)
24,873 (58.4%)
56,177 (54.9%)
56,075 (54.8%)
98,013 (56.1%)
97,969 (56.1%)
0.00
Concomitant initiation or current use of SGLT2i; n 
(%)
429 (1.4%)
433 (1.5%)
501 (1.2%)
524 (1.2%)
1,159 (1.1%)
1,179 (1.2%)
2,089 (1.2%)
2,136 (1.2%)
0.00
Concomitant initiation or current use of AGIs; n (%)
61 (0.2%)
64 (0.2%)
95 (0.2%)
89 (0.2%)
289 (0.3%)
289 (0.3%)
445 (0.3%)
442 (0.3%)
0.00
Concomitant initiation or current use of Glitazones; 
n (%)
1,457 (4.9%)
1,440 (4.8%)
2,368 (5.6%)
2,260 (5.3%)
3,357 (3.3%)
3,309 (3.2%)
7,182 (4.1%)
7,009 (4.0%)
0.01
Concomitant initiation or current use of GLP-1 RA; n 
(%)
70 (0.2%)
67 (0.2%)
55 (0.1%)
57 (0.1%)
119 (0.1%)
111 (0.1%)
244 (0.1%)
235 (0.1%)
0.00
Concomitant initiation or current use of Insulin; n 
(%)
3,960 (13.3%)
3,969 (13.4%)
4,274 (10.0%)
4,170 (9.8%)
15,825 (15.5%)
15,444 (15.1%)
24,059 (13.8%)
23,583 (13.5%)
0.01
Concomitant initiation or current use of 
Meglitinides; n (%)
316 (1.1%)
475 (1.6%)
746 (1.8%)
939 (2.2%)
1,784 (1.7%)
1,940 (1.9%)
2,846 (1.6%)
3,354 (1.9%)
-0.02
Concomitant initiation or current use of Metformin; 
n (%)
13,532 (45.5%)
13,632 (45.9%)
20,013 (47.0%)
20,149 (47.3%)
43,913 (42.9%)
43,951 (42.9%)
77,458 (44.3%)
77,732 (44.5%)
0.00
Past use of SGLT2i; n (%)
215 (0.7%)
209 (0.7%)
212 (0.5%)
203 (0.5%)
582 (0.6%)
557 (0.5%)
1,009 (0.6%)
969 (0.6%)
0.00
Past use of AGIs ; n (%)
35 (0.1%)
32 (0.1%)
41 (0.1%)
44 (0.1%)
122 (0.1%)
125 (0.1%)
198 (0.1%)
201 (0.1%)
0.00
Past use of Glitazones ; n (%)
1,235 (4.2%)
1,256 (4.2%)
2,156 (5.1%)
2,126 (5.0%)
2,535 (2.5%)
2,542 (2.5%)
5,926 (3.4%)
5,924 (3.4%)
0.00
Past use of GLP-1 RA ; n (%)
131 (0.4%)
124 (0.4%)
129 (0.3%)
133 (0.3%)
235 (0.2%)
221 (0.2%)
495 (0.3%)
478 (0.3%)
0.00
Past use of Insulin ; n (%)
1,920 (6.5%)
1,850 (6.2%)
2,253 (5.3%)
2,305 (5.4%)
7,103 (6.9%)
6,882 (6.7%)
11,276 (6.5%)
11,037 (6.3%)
0.01
Past use of Meglitinides ; n (%)
261 (0.9%)
184 (0.6%)
565 (1.3%)
394 (0.9%)
798 (0.8%)
796 (0.8%)
1,624 (0.9%)
1,374 (0.8%)
0.01
Past use of metformin (final) ; n (%)
3,502 (11.8%)
3,389 (11.4%)
4,789 (11.2%)
4,724 (11.1%)
12,264 (12.0%)
12,124 (11.8%)
20,555 (11.8%)
20,237 (11.6%)
0.01
Other Medications
Use of ACE inhibitors; n (%)
12,130 (40.8%)
12,196 (41.0%)
17,833 (41.9%)
17,824 (41.8%)
40,301 (39.4%)
40,254 (39.3%)
70,264 (40.2%)
70,274 (40.2%)
0.00
Use of ARBs; n (%)
8,377 (28.2%)
8,297 (27.9%)
12,003 (28.2%)
12,003 (28.2%)
31,904 (31.2%)
31,978 (31.2%)
52,284 (29.9%)
52,278 (29.9%)
0.00
Use of Loop Diuretics - ; n (%)
6,654 (22.4%)
6,700 (22.5%)
8,970 (21.1%)
8,915 (20.9%)
29,451 (28.8%)
29,240 (28.6%)
45,075 (25.8%)
44,855 (25.7%)
0.00
Use of other diuretics- ; n (%)
1,482 (5.0%)
1,460 (4.9%)
2,026 (4.8%)
2,032 (4.8%)
5,716 (5.6%)
5,595 (5.5%)
9,224 (5.3%)
9,087 (5.2%)
0.00
Use of nitrates-; n (%)
4,156 (14.0%)
4,225 (14.2%)
6,759 (15.9%)
6,740 (15.8%)
16,769 (16.4%)
16,892 (16.5%)
27,684 (15.8%)
27,857 (15.9%)
0.00
Use of other hypertension drugs; n (%)
2,725 (9.2%)
2,775 (9.3%)
3,435 (8.1%)
3,452 (8.1%)
11,247 (11.0%)
11,238 (11.0%)
17,407 (10.0%)
17,465 (10.0%)
0.00
Use of digoxin- ; n (%)
1,243 (4.2%)
1,265 (4.3%)
2,096 (4.9%)
2,094 (4.9%)
5,653 (5.5%)
5,682 (5.5%)
8,992 (5.1%)
9,041 (5.2%)
0.00
Use of Anti-arrhythmics; n (%)
1,009 (3.4%)
1,037 (3.5%)
1,646 (3.9%)
1,637 (3.8%)
4,512 (4.4%)
4,398 (4.3%)
7,167 (4.1%)
7,072 (4.0%)
0.01
Use of COPD/asthma meds- ; n (%)
5,314 (17.9%)
5,331 (17.9%)
7,511 (17.6%)
7,445 (17.5%)
22,193 (21.7%)
22,356 (21.8%)
35,018 (20.0%)
35,132 (20.1%)
0.00
Use of statins; n (%)
21,217 (71.4%)
21,259 (71.5%)
30,505 (71.6%)
30,420 (71.4%)
74,884 (73.1%)
74,789 (73.0%)
126,606 (72.5%)
126,468 (72.4%)
0.00
Use of other lipid-lowering drugs; n (%)
4,653 (15.7%)
4,636 (15.6%)
8,222 (19.3%)
8,219 (19.3%)
14,426 (14.1%)
14,315 (14.0%)
27,301 (15.6%)
27,170 (15.5%)
0.00
Use of antiplatelet agents; n (%)
8,723 (29.3%)
8,787 (29.6%)
14,464 (34.0%)
14,420 (33.8%)
29,939 (29.2%)
30,180 (29.5%)
53,126 (30.4%)
53,387 (30.6%)
0.00
Use of oral anticoagulants (Dabigatran, Rivaroxaban, 
Apixaban, Warfarin); n (%)
3,349 (11.3%)
3,375 (11.4%)
4,638 (10.9%)
4,669 (11.0%)
15,605 (15.2%)
15,554 (15.2%)
23,592 (13.5%)
23,598 (13.5%)
0.00
Use of heparin and other low-molecular weight 
heparins; n (%)
266 (0.9%)
249 (0.8%)
36 (0.1%)
31 (0.1%)
932 (0.9%)
931 (0.9%)
1,234 (0.7%)
1,211 (0.7%)
0.00
Use of NSAIDs; n (%)
4,026 (13.5%)
4,031 (13.6%)
5,599 (13.1%)
5,656 (13.3%)
16,708 (16.3%)
16,790 (16.4%)
26,333 (15.1%)
26,477 (15.2%)
0.00
Use of oral corticosteroids; n (%)
5,138 (17.3%)
5,237 (17.6%)
7,511 (17.6%)
7,423 (17.4%)
22,295 (21.8%)
22,282 (21.8%)
34,944 (20.0%)
34,942 (20.0%)
0.00
Use of bisphosphonate (); n (%)
939 (3.2%)
924 (3.1%)
1,106 (2.6%)
1,119 (2.6%)
4,332 (4.2%)
4,362 (4.3%)
6,377 (3.6%)
6,405 (3.7%)
-0.01
Use of opioids- ; n (%)
9,061 (30.5%)
9,112 (30.7%)
13,177 (30.9%)
13,185 (31.0%)
32,771 (32.0%)
32,800 (32.0%)
55,009 (31.5%)
55,097 (31.5%)
0.00
Use of antidepressants; n (%)
7,899 (26.6%)
7,878 (26.5%)
10,404 (24.4%)
10,233 (24.0%)
31,518 (30.8%)
31,530 (30.8%)
49,821 (28.5%)
49,641 (28.4%)
0.00
Use of antipsychotics; n (%)
982 (3.3%)
988 (3.3%)
1,038 (2.4%)
994 (2.3%)
5,625 (5.5%)
5,472 (5.3%)
7,645 (4.4%)
7,454 (4.3%)
0.00
Use of anticonvulsants; n (%)
5,309 (17.9%)
5,312 (17.9%)
6,020 (14.1%)
5,899 (13.8%)
22,554 (22.0%)
22,494 (22.0%)
33,883 (19.4%)
33,705 (19.3%)
0.00
Use of lithium- ; n (%)
49 (0.2%)
46 (0.2%)
64 (0.2%)
62 (0.1%)
169 (0.2%)
124 (0.1%)
282 (0.2%)
232 (0.1%)
0.03
Use of Benzos- ; n (%)
3,328 (11.2%)
3,370 (11.3%)
5,785 (13.6%)
5,788 (13.6%)
13,195 (12.9%)
13,059 (12.8%)
22,308 (12.8%)
22,217 (12.7%)
0.00
Use of anxiolytics/hypnotics- ; n (%)
2,212 (7.4%)
2,250 (7.6%)
3,697 (8.7%)
3,609 (8.5%)
8,941 (8.7%)
9,025 (8.8%)
14,850 (8.5%)
14,884 (8.5%)
0.00
Use of dementia meds- ; n (%)
1,145 (3.9%)
1,142 (3.8%)
1,201 (2.8%)
1,199 (2.8%)
8,554 (8.4%)
8,470 (8.3%)
10,900 (6.2%)
10,811 (6.2%)
0.00
Use of antiparkinsonian meds- ; n (%)
875 (2.9%)
915 (3.1%)
1,237 (2.9%)
1,176 (2.8%)
4,679 (4.6%)
4,656 (4.5%)
6,791 (3.9%)
6,747 (3.9%)
0.00
Any use of pramlintide; n (%)
8 (0.0%)
9 (0.0%)
28 (0.1%)
37 (0.1%)
12 (0.0%)
27 (0.0%)
048 (0.0%)
073 (0.0%)
#DIV/0!
Any use of 1st generation sulfonylureas; n (%)
15 (0.1%)
11 (0.0%)
41 (0.1%)
15 (0.0%)
51 (0.0%)
27 (0.0%)
107 (0.1%)
053 (0.0%)
0.00
Entresto (sacubitril/valsartan); n (%)
56 (0.2%)
65 (0.2%)
23 (0.1%)
19 (0.0%)
93 (0.1%)
120 (0.1%)
172 (0.1%)
204 (0.1%)
0.00
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Initiation as monotherapy v4 ; n (%)
7,093 (23.9%)
7,240 (24.4%)
9,995 (23.5%)
10,304 (24.2%)
20,129 (19.7%)
20,714 (20.2%)
37,217 (21.3%)
38,258 (21.9%)
-0.01
Labs
                                          72,327                                           72,327 
Lab values- HbA1c (%) ; n (%)
8,669 (29.2%)
8,827 (29.7%)
2,042 (4.8%)
1,847 (4.3%)
N/A
N/A
10,711 (14.8%)
10,674 (14.8%)
0.00
Lab values- HbA1c (%) (within 3 months) ; n (%)
6,595 (22.2%)
6,705 (22.6%)
1,575 (3.7%)
1,424 (3.3%)
N/A
N/A
8,170 (11.3%)
8,129 (11.2%)
0.00
Lab values- HbA1c (%) (within 6 months) ; n (%)
8,669 (29.2%)
8,827 (29.7%)
2,042 (4.8%)
1,847 (4.3%)
N/A
N/A
10,711 (14.8%)
10,674 (14.8%)
0.00
Lab values- BNP; n (%)
329 (1.1%)
354 (1.2%)
66 (0.2%)
73 (0.2%)
N/A
N/A
395 (0.5%)
427 (0.6%)
-0.01
Lab values- BNP (within 3 months); n (%)
201 (0.7%)
219 (0.7%)
42 (0.1%)
54 (0.1%)
N/A
N/A
243 (0.3%)
273 (0.4%)
-0.02
Lab values- BNP (within 6 months); n (%)
329 (1.1%)
354 (1.2%)
66 (0.2%)
73 (0.2%)
N/A
N/A
395 (0.5%)
427 (0.6%)
-0.01
Lab values- BUN (mg/dl); n (%)
9,465 (31.8%)
9,769 (32.9%)
1,999 (4.7%)
2,034 (4.8%)
N/A
N/A
11,464 (15.9%)
11,803 (16.3%)
-0.01
Lab values- BUN (mg/dl) (within 3 months); n (%)
7,205 (24.2%)
7,482 (25.2%)
1,527 (3.6%)
1,550 (3.6%)
N/A
N/A
8,732 (12.1%)
9,032 (12.5%)
-0.01
Lab values- BUN (mg/dl) (within 6 months); n (%)
9,465 (31.8%)
9,769 (32.9%)
1,999 (4.7%)
2,034 (4.8%)
N/A
N/A
11,464 (15.9%)
11,803 (16.3%)
-0.01
Lab values- Creatinine (mg/dl) ; n (%)
9,694 (32.6%)
10,013 (33.7%)
2,137 (5.0%)
2,158 (5.1%)
N/A
N/A
11,831 (16.4%)
12,171 (16.8%)
-0.01
Lab values- Creatinine (mg/dl) (within 3 months) ; n 
(%)
7,384 (24.8%)
7,681 (25.8%)
1,642 (3.9%)
1,636 (3.8%)
N/A
N/A
9,026 (12.5%)
9,317 (12.9%)
-0.01
Lab values- Creatinine (mg/dl) (within 6 months) ; n 
(%)
9,694 (32.6%)
10,013 (33.7%)
2,137 (5.0%)
2,158 (5.1%)
N/A
N/A
11,831 (16.4%)
12,171 (16.8%)
-0.01
Lab values- HDL level (mg/dl); n (%)
7,615 (25.6%)
7,857 (26.4%)
1,837 (4.3%)
1,684 (4.0%)
N/A
N/A
9,452 (13.1%)
9,541 (13.2%)
0.00
Lab values- HDL level (mg/dl) (within 3 months); n (%)
5,408 (18.2%)
5,644 (19.0%)
1,322 (3.1%)
1,239 (2.9%)
N/A
N/A
6,730 (9.3%)
6,883 (9.5%)
-0.01
Lab values- HDL level (mg/dl) (within 6 months); n (%)
7,615 (25.6%)
7,857 (26.4%)
1,837 (4.3%)
1,684 (4.0%)
N/A
N/A
9,452 (13.1%)
9,541 (13.2%)
0.00
Lab values- LDL level (mg/dl) ; n (%)
7,779 (26.2%)
8,047 (27.1%)
1,951 (4.6%)
1,792 (4.2%)
N/A
N/A
9,730 (13.5%)
9,839 (13.6%)
0.00
Lab values- LDL level (mg/dl) (within 3 months) ; n (%)
5,526 (18.6%)
5,768 (19.4%)
1,406 (3.3%)
1,317 (3.1%)
N/A
N/A
6,932 (9.6%)
7,085 (9.8%)
-0.01
Lab values- LDL level (mg/dl) (within 6 months) ; n (%)
7,779 (26.2%)
8,047 (27.1%)
1,951 (4.6%)
1,792 (4.2%)
N/A
N/A
9,730 (13.5%)
9,839 (13.6%)
0.00
Lab values- NT-proBNP; n (%)
46 (0.2%)
43 (0.1%)
3 (0.0%)
3 (0.0%)
N/A
N/A
49 (0.1%)
0 (0.1%)
-
Lab values- NT-proBNP (within 3 months); n (%)
28 (0.1%)
19 (0.1%)
2 (0.0%)
2 (0.0%)
N/A
N/A
30 (0.0%)
0 (0.0%)
-
Lab values- NT-proBNP (within 6 months); n (%)
46 (0.2%)
43 (0.1%)
3 (0.0%)
3 (0.0%)
N/A
N/A
49 (0.1%)
46 (0.1%)
-
Lab values- Total cholesterol (mg/dl) ; n (%)
7,723 (26.0%)
7,976 (26.8%)
1,908 (4.5%)
1,761 (4.1%)
N/A
N/A
9,631 (13.3%)
9,737 (13.5%)
-0.01
Lab values- Total cholesterol (mg/dl) (within 3 
months) ; n (%)
5,490 (18.5%)
5,723 (19.3%)
1,373 (3.2%)
1,289 (3.0%)
N/A
N/A
6,863 (9.5%)
7,012 (9.7%)
-0.01
Lab values- Total cholesterol (mg/dl) (within 6 
months) ; n (%)
7,723 (26.0%)
7,976 (26.8%)
1,908 (4.5%)
1,761 (4.1%)
N/A
N/A
9,631 (13.3%)
9,737 (13.5%)
-0.01
Lab values- Triglyceride level (mg/dl); n (%)
7,638 (25.7%)
7,867 (26.5%)
1,873 (4.4%)
1,730 (4.1%)
N/A
N/A
9,511 (13.1%)
9,597 (13.3%)
-0.01
Lab values- Triglyceride level (mg/dl) (within 3 
months); n (%)
5,426 (18.3%)
5,641 (19.0%)
1,351 (3.2%)
1,273 (3.0%)
N/A
N/A
6,777 (9.4%)
6,914 (9.6%)
-0.01
Lab values- Triglyceride level (mg/dl) (within 6 
months); n (%)
7,638 (25.7%)
7,867 (26.5%)
1,873 (4.4%)
1,730 (4.1%)
N/A
N/A
9,511 (13.1%)
9,597 (13.3%)
-0.01
Lab result number- HbA1c (%) mean (only 2 to 20 
included) v4
8,595
                                            
8,741
                                            
1,872
                                            
1,782
                                            
N/A
N/A                                           10,467                                           10,523 
...mean (sd)
7.99 (1.78)
7.78 (1.69)
8.13 (1.88)
7.90 (1.75)
N/A
N/A
8.02 (1.80)
7.80 (1.70)
0.13
...median [IQR]
7.60 [6.80, 8.80]
7.40 [6.60, 8.50]
7.70 [6.80, 9.00]
7.45 [6.70, 8.65]
N/A
N/A
7.62 (1.80)
7.41 (1.70)
0.12
...Missing; n (%)
21,132 (71.1%)
20,986 (70.6%)
40,728 (95.6%)
40,818 (95.8%)
N/A
N/A
61,860 (85.5%)
61,804 (85.5%)
0.00
Lab result number- BNP mean 
329
                                                
354
                                                
66
                                                   
73
                                                   
N/A
N/A                                                  395                                                  427 
...mean (sd)
221.45 (330.00)
212.58 (353.05)
324.29 (602.41)
213.53 (315.86)
N/A
N/A
238.63 (388.97)
212.74 (347.44)
0.07
...median [IQR]
97.00 [38.70, 238.45]
106.60 [36.45, 239.20]
89.50 [29.62, 339.62]
101.00 [32.00, 264.25]
N/A
N/A
#VALUE!
105.64 (347.44)
#VALUE!
...Missing; n (%)
29,398 (98.9%)
29,373 (98.8%)
42,534 (99.8%)
42,527 (99.8%)
N/A
N/A
71,932 (99.5%)
71,900 (99.4%)
0.01
Lab result number- BUN (mg/dl) mean 
                                             9,465                                              9,769                                              1,999                                              2,034 
N/A
N/A                                           11,464                                           11,803 
...mean (sd)
20.54 (9.90)
20.26 (9.38)
844.91 (11,853.76)
221.96 (5,038.61)
N/A
N/A
164.29 (4949.29)
55.02 (2091.42)
0.03
...median [IQR]
18.00 [14.00, 24.00]
18.00 [14.00, 23.77]
17.00 [14.00, 22.00]
17.00 [14.00, 22.00]
N/A
N/A
#VALUE!
#VALUE!
#VALUE!
...Missing; n (%)
20,262 (68.2%)
19,958 (67.1%)
40,601 (95.3%)
40,566 (95.2%)
N/A
N/A
60,863 (84.1%)
60,524 (83.7%)
0.01
Lab result number- Creatinine (mg/dl) mean (only 0.1 
to 15 included) 
                                             9,619                                              9,904                                              2,042                                              2,033 
N/A
N/A                                           11,661                                           11,937 
...mean (sd)
1.13 (0.55)
1.13 (0.55)
1.07 (0.59)
1.05 (0.51)
N/A
N/A
1.12 (0.56)
1.12 (0.54)
0.00
...median [IQR]
1.01 [0.83, 1.29]
1.02 [0.84, 1.28]
0.98 [0.80, 1.16]
0.98 [0.81, 1.15]
N/A
N/A
1.00 (0.56)
1.01 (0.54)
-0.02
...Missing; n (%)
20,108 (67.6%)
19,823 (66.7%)
40,558 (95.2%)
40,567 (95.2%)
N/A
N/A
60,666 (83.9%)
60,390 (83.5%)
0.01
Lab result number- HDL level (mg/dl) mean (only 
=<5000 included) 
                                             7,615                                              7,857                                              1,830                                              1,683 
N/A
N/A                                              9,445                                              9,540 
...mean (sd)
44.85 (13.87)
45.38 (14.01)
43.92 (15.63)
43.57 (14.19)
N/A
N/A
44.67 (14.23)
45.06 (14.04)
-0.03
...median [IQR]
43.00 [36.00, 52.00]
44.00 [36.00, 53.00]
42.00 [35.00, 51.00]
42.00 [35.00, 51.00]
N/A
N/A
42.81 (14.23)
43.65 (14.04)
-0.06
...Missing; n (%)
22,112 (74.4%)
21,870 (73.6%)
40,770 (95.7%)
40,917 (96.0%)
N/A
N/A
62,882 (86.9%)
62,787 (86.8%)
0.00
Lab result number- LDL level (mg/dl) mean (only 
=<5000 included) 
                                             7,617                                              7,885                                              1,824                                              1,694 
N/A
N/A                                              9,441                                              9,579 
...mean (sd)
85.26 (40.77)
83.19 (39.97)
87.55 (41.77)
86.51 (42.89)
N/A
N/A
85.70 (40.97)
83.78 (40.50)
0.05
...median [IQR]
82.00 [61.00, 109.00]
79.40 [59.00, 104.00]
85.00 [62.50, 112.00]
83.00 [62.00, 111.00]
N/A
N/A
82.58 (40.97)
80.04 (40.50)
0.06
...Missing; n (%)
22,110 (74.4%)
21,842 (73.5%)
40,776 (95.7%)
40,906 (96.0%)
N/A
N/A
62,886 (86.9%)
62,748 (86.8%)
0.00
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Lab result number- Total cholesterol (mg/dl) mean 
(only =<5000 included) 
                                             7,718                                              7,965                                              1,900                                              1,757 
N/A
N/A                                              9,618                                              9,722 
...mean (sd)
170.55 (48.85)
167.26 (48.37)
172.88 (50.42)
171.42 (51.31)
N/A
N/A
171.01 (49.17)
168.01 (48.92)
0.06
...median [IQR]
164.00 [138.00, 197.00]
161.00 [136.50, 191.50]
167.00 [142.00, 199.00]
166.00 [140.00, 198.00]
N/A
N/A
164.59 (49.17)
161.90 (48.92)
0.05
...Missing; n (%)
22,009 (74.0%)
21,762 (73.2%)
40,700 (95.5%)
40,843 (95.9%)
N/A
N/A
62,709 (86.7%)
62,605 (86.6%)
0.00
Lab result number- Triglyceride level (mg/dl) mean 
(only =<5000 included) 
                                             7,638                                              7,867                                              1,866                                              1,729 
N/A
N/A                                              9,504                                              9,596 
...mean (sd)
187.28 (156.16)
178.93 (148.77)
189.86 (160.62)
191.36 (174.88)
N/A
N/A
187.79 (157.05)
181.17 (153.81)
0.04
...median [IQR]
152.00 [109.00, 215.00]
146.00 [104.00, 210.00]
152.00 [106.38, 218.50]
149.33 [106.25, 219.00]
N/A
N/A
152.00 (157.05)
146.60 (153.81)
0.03
...Missing; n (%)
22,089 (74.3%)
21,860 (73.5%)
40,734 (95.6%)
40,871 (95.9%)
N/A
N/A
62,823 (86.9%)
62,731 (86.7%)
0.01
Lab result number- Hemoglobin mean (only >0 
included)
                                             7,029                                              7,205                                              1,467                                              1,399 
N/A
N/A                                              8,496                                              8,604 
...mean (sd)
13.26 (1.79)
13.26 (1.76)
612.63 (9,372.79)
321.61 (6,152.32)
N/A
N/A
116.75 (3894.08)
63.40 (2480.38)
0.02
...median [IQR]
13.30 [12.10, 14.50]
13.30 [12.10, 14.50]
13.50 [12.30, 14.70]
13.50 [12.30, 14.70]
N/A
N/A
#VALUE!
#VALUE!
#VALUE!
...Missing; n (%)
22,698 (76.4%)
22,522 (75.8%)
41,133 (96.6%)
41,201 (96.7%)
N/A
N/A
63,831 (88.3%)
63,723 (88.1%)
0.01
Lab result number- Serum sodium mean (only > 90 
and < 190 included)
                                             9,400                                              9,693                                              1,874                                              1,847 
N/A
N/A                                           11,274                                           11,540 
...mean (sd)
139.35 (2.89)
139.52 (2.83)
138.98 (2.87)
139.11 (2.74)
N/A
N/A
139.29 (2.89)
139.45 (2.82)
-0.06
...median [IQR]
139.50 [138.00, 141.00]
140.00 [138.00, 141.33]
139.00 [137.50, 141.00]
139.00 [137.50, 141.00]
N/A
N/A
139.42 (2.89)
139.84 (2.82)
-0.15
...Missing; n (%)
20,327 (68.4%)
20,034 (67.4%)
40,726 (95.6%)
40,753 (95.7%)
N/A
N/A
61,053 (84.4%)
60,787 (84.0%)
0.01
Lab result number- Albumin mean (only >0 and <=10 
included)
                                             8,711                                              9,009                                              1,706                                              1,663 
N/A
N/A                                           10,417                                           10,672 
...mean (sd)
4.17 (0.35)
4.17 (0.35)
4.15 (0.52)
4.14 (0.59)
N/A
N/A
4.17 (0.38)
4.17 (0.40)
0.00
...median [IQR]
4.20 [4.00, 4.40]
4.20 [4.00, 4.40]
4.20 [4.00, 4.40]
4.20 [4.00, 4.43]
N/A
N/A
4.20 (0.38)
4.20 (0.40)
0.00
...Missing; n (%)
21,016 (70.7%)
20,718 (69.7%)
40,894 (96.0%)
40,937 (96.1%)
N/A
N/A
61,910 (85.6%)
61,655 (85.2%)
0.01
Lab result number- Glucose (fasting or random) mean 
(only 10-1000 included)
                                             9,394                                              9,695                                              1,867                                              1,826 
N/A
N/A                                           11,261                                           11,521 
...mean (sd)
168.15 (72.56)
161.26 (67.24)
173.78 (76.66)
164.94 (72.28)
N/A
N/A
169.08 (73.26)
161.84 (68.07)
0.10
...median [IQR]
150.00 [121.00, 195.50]
144.00 [117.00, 185.00]
153.67 [124.00, 202.50]
145.00 [119.00, 189.00]
N/A
N/A
150.61 (73.26)
144.16 (68.07)
0.09
...Missing; n (%)
20,333 (68.4%)
20,032 (67.4%)
40,733 (95.6%)
40,774 (95.7%)
N/A
N/A
61,066 (84.4%)
60,806 (84.1%)
0.01
Lab result number- Potassium mean (only 1-7 
included)
                                             9,573                                              9,878                                              1,980                                              1,995 
N/A
N/A                                           11,553                                           11,873 
...mean (sd)
4.45 (0.45)
4.43 (0.45)
4.37 (0.44)
4.38 (0.44)
N/A
N/A
4.44 (0.45)
4.42 (0.45)
0.04
...median [IQR]
4.40 [4.15, 4.70]
4.40 [4.12, 4.70]
4.35 [4.05, 4.70]
4.40 [4.10, 4.65]
N/A
N/A
4.39 (0.45)
4.40 (0.45)
-0.02
...Missing; n (%)
20,154 (67.8%)
19,849 (66.8%)
40,620 (95.4%)
40,605 (95.3%)
N/A
N/A
60,774 (84.0%)
60,454 (83.6%)
0.01
Comorbidity Scores
CCI (180 days)- ICD9 and ICD10 
...mean (sd)
3.53 (2.31)
3.54 (2.35)
2.57 (2.10)
2.56 (2.12)
4.21 (2.40)
4.19 (2.41)
3.69 (2.31)
3.68 (2.33)
0.00
...median [IQR]
3.00 [2.00, 5.00]
3.00 [2.00, 5.00]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
4.00 [2.00, 6.00]
4.00 [2.00, 6.00]
3.34 (2.31)
3.34 (2.33)
0.00
Frailty Score: Qualitative Version 365 days as 
Categories, v1
...0; n (%)
6,384 (21.5%)
5,865 (19.7%)
3,424 (8.0%)
3,464 (8.1%)
15,773 (15.4%)
15,429 (15.1%)
25,581 (14.6%)
24,758 (14.2%)
0.01
...1 to 2; n (%)
10,115 (34.0%)
10,511 (35.4%)
18,141 (42.6%)
18,211 (42.7%)
24,197 (23.6%)
24,350 (23.8%)
52,453 (30.0%)
53,072 (30.4%)
-0.01
...3 or more; n (%)
13,228 (44.5%)
13,351 (44.9%)
21,035 (49.4%)
20,925 (49.1%)
62,441 (61.0%)
62,632 (61.2%)
96,704 (55.3%)
96,908 (55.5%)
0.00
Frailty Score: Empirical Version 365 days as 
Categories, 
...< 0.12908; n (%)
1,610 (5.4%)
1,675 (5.6%)
2,733 (6.4%)
2,919 (6.9%)
1,887 (1.8%)
2,260 (2.2%)
6,230 (3.6%)
6,854 (3.9%)
-0.02
...0.12908 - 0.1631167; n (%)
6,451 (21.7%)
6,526 (22.0%)
10,144 (23.8%)
10,347 (24.3%)
10,000 (9.8%)
10,659 (10.4%)
26,595 (15.2%)
27,532 (15.8%)
-0.02
...>= 0.1631167; n (%)
21,666 (72.9%)
21,526 (72.4%)
29,723 (69.8%)
29,334 (68.9%)
90,524 (88.4%)
89,492 (87.4%)
141,913 (81.2%)
140,352 (80.3%)
0.02
Non-Frailty; n (%)
16,772 (56.4%)
16,976 (57.1%)
21,481 (50.4%)
21,489 (50.4%)
3,954 (3.9%)
3,683 (3.6%)
42,207 (24.2%)
42,148 (24.1%)
0.00
Frailty Score (mean): Qualitative Version 365 days, v1
...mean (sd)
2.71 (2.55)
2.75 (2.55)
2.95 (2.22)
2.95 (2.24)
3.72 (2.94)
3.73 (2.95)
3.36 (2.72)
3.37 (2.73)
0.00
...median [IQR]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
2.00 [1.00, 4.00]
3.00 [1.00, 6.00]
3.00 [1.00, 6.00]
2.59 (2.72)
2.59 (2.73)
0.00
Frailty Score (mean): Empirical Version 365 days, 
...mean (sd)
0.17 (0.07)
0.17 (0.07)
0.19 (0.06)
0.19 (0.06)
0.25 (0.08)
0.25 (0.08)
0.22 (0.07)
0.22 (0.07)
0.00
...median [IQR]
0.16 [0.12, 0.21]
0.16 [0.12, 0.21]
0.18 [0.15, 0.22]
0.18 [0.15, 0.21]
0.23 [0.19, 0.29]
0.23 [0.19, 0.29]
0.21 (0.07)
0.21 (0.07)
0.00
Healthcare Utilization
Any hospitalization; n (%)
6,882 (23.2%)
6,765 (22.8%)
11,065 (26.0%)
11,100 (26.1%)
27,916 (27.3%)
27,495 (26.8%)
45,863 (26.2%)
45,360 (26.0%)
0.00
Any hospitalization within prior 30 days; n (%)
2,859 (9.6%)
2,900 (9.8%)
4,437 (10.4%)
4,490 (10.5%)
10,985 (10.7%)
10,851 (10.6%)
18,281 (10.5%)
18,241 (10.4%)
0.00
Any hospitalization during prior 31-180 days; n (%)
4,537 (15.3%)
4,531 (15.2%)
7,362 (17.3%)
7,387 (17.3%)
19,769 (19.3%)
19,486 (19.0%)
31,668 (18.1%)
31,404 (18.0%)
0.00
Endocrinologist Visit; n (%)
3,404 (11.5%)
3,551 (11.9%)
4,825 (11.3%)
4,946 (11.6%)
12,520 (12.2%)
12,940 (12.6%)
20,749 (11.9%)
21,437 (12.3%)
-0.01
Endocrinologist Visit (30 days prior); n (%)
2,140 (7.2%)
2,169 (7.3%)
3,180 (7.5%)
3,140 (7.4%)
7,592 (7.4%)
7,411 (7.2%)
12,912 (7.4%)
12,720 (7.3%)
0.00
Endocrinologist Visit (31 to 180 days prior); n (%)
2,399 (8.1%)
2,412 (8.1%)
3,183 (7.5%)
3,195 (7.5%)
9,156 (8.9%)
9,098 (8.9%)
14,738 (8.4%)
14,705 (8.4%)
0.00
Internal medicine/family medicine visits; n (%)
26,096 (87.8%)
25,836 (86.9%)
36,484 (85.6%)
36,277 (85.2%)
89,704 (87.6%)
89,135 (87.0%)
152,284 (87.1%)
151,248 (86.6%)
0.01
Internal medicine/family medicine visits (30 days 
prior) ; n (%)
19,588 (65.9%)
19,501 (65.6%)
26,797 (62.9%)
26,480 (62.2%)
64,921 (63.4%)
64,807 (63.3%)
111,306 (63.7%)
110,788 (63.4%)
0.01
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas

Internal medicine/family medicine visits (31 to 180 
days prior) ; n (%)
23,320 (78.4%)
23,349 (78.5%)
32,491 (76.3%)
32,370 (76.0%)
81,075 (79.2%)
80,830 (78.9%)
136,886 (78.3%)
136,549 (78.1%)
0.00
Cardiologist visit; n (%)
16,806 (56.5%)
16,784 (56.5%)
21,071 (49.5%)
20,964 (49.2%)
62,396 (60.9%)
62,201 (60.7%)
100,273 (57.4%)
99,949 (57.2%)
0.00
Number of Cardiologist visits (30 days prior); n (%)
6,841 (23.0%)
6,934 (23.3%)
8,260 (19.4%)
8,178 (19.2%)
25,354 (24.8%)
25,197 (24.6%)
40,455 (23.2%)
40,309 (23.1%)
0.00
Number of Cardiologist visits (31 to 180 days prior); 
n (%)
14,105 (47.4%)
14,093 (47.4%)
17,962 (42.2%)
17,810 (41.8%)
53,633 (52.4%)
53,527 (52.3%)
85,700 (49.0%)
85,430 (48.9%)
0.00
Electrocardiogram ; n (%)
15,569 (52.4%)
15,698 (52.8%)
21,582 (50.7%)
21,691 (50.9%)
58,001 (56.6%)
58,332 (57.0%)
95,152 (54.5%)
95,721 (54.8%)
-0.01
Use of glucose test strips; n (%)
1,526 (5.1%)
1,536 (5.2%)
1,947 (4.6%)
1,947 (4.6%)
4,540 (4.4%)
4,587 (4.5%)
8,013 (4.6%)
8,070 (4.6%)
0.00
Dialysis; n (%)
143 (0.5%)
122 (0.4%)
209 (0.5%)
225 (0.5%)
1,302 (1.3%)
1,191 (1.2%)
1,654 (0.9%)
1,538 (0.9%)
0.00
Naive new user v8 ; n (%)
10,615 (35.7%)
10,728 (36.1%)
15,150 (35.6%)
15,436 (36.2%)
32,363 (31.6%)
32,876 (32.1%)
58,128 (33.3%)
59,040 (33.8%)
-0.01
N antidiabetic drugs at index date  
...mean (sd)
1.67 (0.68)
1.68 (0.66)
1.66 (0.67)
1.66 (0.65)
1.65 (0.67)
1.65 (0.65)
1.66 (0.67)
1.66 (0.65)
0.00
...median [IQR]
2.00 [1.00, 2.00]
2.00 [1.00, 2.00]
2.00 [1.00, 2.00]
2.00 [1.00, 2.00]
2.00 [1.00, 2.00]
2.00 [1.00, 2.00]
2.00 (0.67)
2.00 (0.65)
0.00
number of different/distinct medication 
prescriptions
...mean (sd)
11.17 (5.48)
11.19 (5.59)
10.87 (5.26)
10.82 (5.31)
11.81 (5.35)
11.79 (5.49)
11.47 (5.35)
11.45 (5.46)
0.00
...median [IQR]
10.00 [7.00, 14.00]
10.00 [7.00, 14.00]
10.00 [7.00, 14.00]
10.00 [7.00, 14.00]
11.00 [8.00, 15.00]
11.00 [8.00, 15.00]
10.59 (5.35)
10.59 (5.46)
0.00
Number of Hospitalizations
...mean (sd)
0.30 (0.62)
0.30 (0.65)
0.32 (0.62)
0.32 (0.63)
0.40 (0.77)
0.39 (0.77)
0.36 (0.71)
0.36 (0.72)
0.00
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (0.71)
0.00 (0.72)
0.00
Number of hospital days
...mean (sd)
1.90 (5.67)
1.95 (6.01)
2.18 (6.63)
2.16 (6.53)
2.78 (7.68)
2.72 (7.30)
2.48 (7.12)
2.45 (6.91)
0.00
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 2.00]
0.00 [0.00, 2.00]
0.00 [0.00, 3.00]
0.00 [0.00, 3.00]
0.00 (7.12)
0.00 (6.91)
0.00
Number of Emergency Department (ED) visits 
...mean (sd)
0.73 (1.64)
0.74 (1.78)
0.49 (2.08)
0.49 (2.24)
0.99 (1.84)
0.98 (2.11)
0.82 (1.87)
0.82 (2.09)
0.00
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 2.00]
0.00 [0.00, 2.00]
0.00 (1.87)
0.00 (2.09)
0.00
Number of Office visits
...mean (sd)
6.28 (4.95)
6.29 (4.80)
6.42 (5.51)
6.38 (4.80)
6.99 (5.50)
6.99 (5.42)
6.73 (5.41)
6.72 (5.17)
0.00
...median [IQR]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
5.00 [3.00, 8.00]
6.00 [3.00, 10.00]
6.00 [3.00, 10.00]
5.59 (5.41)
5.59 (5.17)
0.00
Number of Endocrinologist visits
...mean (sd)
0.56 (2.48)
0.58 (2.51)
0.54 (2.42)
0.58 (2.79)
0.71 (3.34)
0.74 (3.52)
0.64 (3.00)
0.67 (3.20)
-0.01
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (3.00)
0.00 (3.20)
0.00
Number of internal medicine/family medicine visits
...mean (sd)
12.02 (17.25)
11.94 (16.11)
8.50 (12.80)
8.74 (12.71)
10.70 (13.45)
10.86 (13.42)
10.39 (14.02)
10.53 (13.75)
-0.01
...median [IQR]
7.00 [3.00, 15.00]
7.00 [3.00, 15.00]
5.00 [2.00, 11.00]
5.00 [2.00, 11.00]
7.00 [3.00, 14.00]
7.00 [3.00, 15.00]
6.51 (14.02)
6.51 (13.75)
0.00
Number of Cardiologist visits
...mean (sd)
3.60 (6.45)
3.71 (6.54)
2.70 (5.12)
2.72 (5.14)
3.91 (6.81)
3.95 (6.94)
3.56 (6.38)
3.61 (6.48)
-0.01
...median [IQR]
1.00 [0.00, 5.00]
1.00 [0.00, 5.00]
0.00 [0.00, 3.00]
0.00 [0.00, 3.00]
1.00 [0.00, 5.00]
1.00 [0.00, 5.00]
0.76 (6.38)
0.76 (6.48)
0.00
Number electrocardiograms received 
...mean (sd)
1.29 (2.17)
1.32 (2.27)
1.08 (1.67)
1.08 (1.71)
1.44 (2.09)
1.43 (2.07)
1.33 (2.01)
1.33 (2.03)
0.00
...median [IQR]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
1.00 [0.00, 1.00]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
1.00 (2.01)
1.00 (2.03)
0.00
Number of HbA1c tests ordered
...mean (sd)
1.21 (0.99)
1.21 (0.96)
0.83 (0.94)
0.82 (0.92)
1.36 (1.00)
1.35 (0.99)
1.21 (0.98)
1.20 (0.97)
0.01
...median [IQR]
1.00 [0.00, 2.00]
1.00 [1.00, 2.00]
1.00 [0.00, 1.00]
1.00 [0.00, 1.00]
1.00 [1.00, 2.00]
1.00 [1.00, 2.00]
1.00 (0.98)
1.00 (0.97)
0.00
Number of glucose tests ordered
...mean (sd)
0.79 (5.17)
0.82 (5.19)
0.50 (1.97)
0.49 (1.71)
0.55 (1.41)
0.55 (1.28)
0.58 (2.58)
0.58 (2.50)
0.00
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (2.58)
0.00 (2.50)
0.00
Number of lipid tests ordered
...mean (sd)
1.04 (1.10)
1.04 (1.07)
0.79 (1.32)
0.78 (1.20)
1.05 (0.96)
1.05 (0.94)
0.98 (1.08)
0.98 (1.03)
0.00
...median [IQR]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
1.00 [0.00, 2.00]
1.00 [0.00, 2.00]
0.76 (1.08)
0.76 (1.03)
0.00
Number of creatinine tests ordered
...mean (sd)
0.10 (0.53)
0.10 (0.46)
0.10 (0.48)
0.09 (0.44)
0.14 (0.59)
0.13 (0.54)
0.12 (0.55)
0.12 (0.50)
0.00
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (0.55)
0.00 (0.50)
0.00
Number of BUN tests ordered
...mean (sd)
0.07 (0.57)
0.07 (0.50)
0.07 (0.48)
0.07 (0.44)
0.10 (0.53)
0.09 (0.49)
0.09 (0.53)
0.08 (0.48)
0.02
...median [IQR]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 (0.53)
0.00 (0.48)
0.00
Number of tests for microalbuminuria
...mean (sd)
0.67 (1.16)
0.66 (1.15)
0.40 (0.90)
0.40 (0.91)
0.43 (0.78)
0.43 (0.76)
0.46 (0.88)
0.46 (0.87)
0.00
...median [IQR]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 [0.00, 0.00]
0.00 [0.00, 0.00]
0.00 [0.00, 1.00]
0.00 [0.00, 1.00]
0.00 (0.88)
0.00 (0.87)
0.00
Total N distinct ICD9/ICD10 diagnoses at the 3rd 
digit level 
...mean (sd)
7.34 (10.04)
7.34 (10.38)
3.62 (7.39)
3.63 (7.40)
9.68 (11.90)
9.57 (11.86)
7.80 (10.65)
7.74 (10.68)
0.01
...median [IQR]
4.00 [0.00, 11.00]
4.00 [0.00, 11.00]
0.00 [0.00, 4.00]
0.00 [0.00, 4.00]
6.00 [0.00, 15.00]
5.00 [0.00, 15.00]
4.20 (10.65)
3.61 (10.68)
0.06
Use of thiazide; n (%)
3,428 (11.5%)
3,358 (11.3%)
4,478 (10.5%)
4,470 (10.5%)
12,338 (12.0%)
12,334 (12.0%)
20,244 (11.6%)
20,162 (11.5%)
0.00
Use of beta blockers; n (%)
16,752 (56.4%)
16,787 (56.5%)
24,718 (58.0%)
24,658 (57.9%)
63,213 (61.7%)
63,051 (61.6%)
104,683 (59.9%)
104,496 (59.8%)
0.00
Use of calcium channel blockers; n (%)
9,269 (31.2%)
9,316 (31.3%)
12,735 (29.9%)
12,730 (29.9%)
37,118 (36.2%)
37,223 (36.3%)
59,122 (33.8%)
59,269 (33.9%)
0.00
Table 1: Sitagliptin vs 2nd Generation Sulfonylureas