Clinical trial NCT02029846
Conditions: Type 2 Diabetes Mellitus
Sponsor: Johns Hopkins University
Start date: 2013-04-01; Completion date: 2017-02-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.

Detailed description:

Arms: arm 1: A regimen with traditional drugs only arm 2: A regimen including incretin-based drugs
Interventions: intervention 1: Standard Treatment intervention 2: Incretin-Based Treatment
Intervention descriptions: intervention 1: traditional drugs only intervention 2: incretin-based drugs

Protocol documents:
Prot_SAP_000.pdf: 
Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 1 of 12 
 
 
 
Title: Glycemia in Diabetic Elders Trial 
 
NCT02029846 
 
Date: June 11, 2013 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 2 of 12 
 
Johns Hopkins Medicine - eForm A 
 
 
 
 Use the section headings to write the eForm A, inserting the appropriate material in each. If a 
section is not applicable, leave heading in and insert N/A. 
 When submitting eForm A (new or revised), enter the date submitted to the field at the top of 
eForm A. 
 
*************************************************************************************************** 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Type 2 diabetes is a common disease in elderly individuals. The population of Medicare enrollees 
with diabetes is projected to rise from 8.2 million in 2009 to 14.6 million in 2034 and associated 
spending is estimated to rise from $45 billion to $171 billion1. Any systematic treatment 
recommendations for these patients could have profound clinical and financial implications. 
However, the optimal choice of drugs for diabetic elders is uncertain: older drugs have been tested 
extensively, but the results of those trials have been mixed and limited to middle‐aged populations2; 
several newer drugs have better short‐term safety (less hypoglycemia) and side‐effect (less weight 
gain) profiles, but have not been well studied in the elderly. The optimal strategy for glycemic 
control in elderly adults with diabetes is also uncertain because of competing risks from 
non‐diabetic conditions and higher risk of adverse drug effects and polypharmacy. Therefore, 
developing effective strategies for diabetic elders that will achieve and maintain HbA1c control 
while minimizing adverse effects and overall drug exposure is a clinical priority.  
 
This study is a randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the 
MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates 
in Baltimore, Maryland and a member of Johns Hopkins Clinical Research Network (JHCRN). We 
hypothesized that compared to a regimen base solely on traditional drugs, a regimen including 
incretin-based drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, 
and other side effects, over the short run.  
 
2. 
Objectives (include all primary and secondary objectives) 
 
The objective is to conduct a pilot comparative effectiveness trial with MODEL Clinical Research 
(MODEL), Research Division of Bay West Endocrinology Associates (BAY), an affiliate of GBMC 
and a member of the Johns Hopkins Clinical Research Network, to compare two treatment 
strategies (regimen using traditional drugs only vs. regimen including incretin-based classes of 
medication) in the elderly patients with type 2 diabetes on time to achieving glycemic target, overall 
hypoglycemia, weight gain, adverse events, and quality of life. This study will provide preliminary 
data on a ‘preferred’ anti-diabetic regimen for elders by comparing and quantify short-term effects 
from treatment regimens in diabetic elders. 
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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The optimal approach to glucose control for patients with type 2 diabetes is uncertain, particularly 
in older patients. For over a decade, glucose lowering recommendations have been primarily based 
on the results of the United Kingdom Prospective Diabetes Study (UKPDS) in middle‐aged patients 
with new onset diabetes4. This trial showed that patients with an average HbA1c of 7.0% had a 
lower rate of microvascular complications than patients with HbA1c of 7.9% More recently 
completed trials suggest possible harm associated with tighter targets (e.g. HbA1c 6.5%) 5, 6. 
Nonetheless, geriatric diabetes care guidelines also have endorsed pursuing an A1c<7.0% for 
healthy older patients with life expectancies greater than 5 years7, admittedly without a firm 
evidence base. However, even traditional targets for glycemic control may include treatments that 
increase the chances of polypharmacy, hypoglycemia, weight gain, geriatric syndromes, and 
worsened quality of life. Severe hypoglycemic episodes have been associated with the development 
of dementia8; polypharmacy has also been shown to increase risk of injurious falls 9,10. To develop 
optimal treatment strategies for diabetic elders, clinical trials specifically conducted in older 
patients with diabetes are needed.  
 
As type 2 diabetes progresses in older persons, intensification is often required to achieve adequate 
glycemic control but with increased risk of adverse effects as a result of age related changes in drug 
metabolism. Incretin-based classes of medication, for example incretins, improve glycemic control 
in older persons. Some clinical evidence suggested that certain DPP‐4 inhibitors (e.g. vildagliptin 
and sitagliptin) are particularly suitable for frail and elderly patients because less gastrointestinal 
effects than metformin and α‐ glucosidase inhibitors, and have a low risk of the hypoglycaemic 
events11. The American Association of Clinical Endocrinologists (AACE) and American College of 
Endocrinology (ACE) Consensus Statement12 recently included incretin-based classes of drugs in 
the Diabetes Algorithm for Glycemic Control. However, the recommendation is largely based on 
expert opinions, not head‐to‐head comparisons. A recent federally‐sponsored literature synthesis by 
our group2 pointed out the deficiencies of evidence in evaluating newest agents and two‐drug 
combinations. Most important, evidence supporting one regimen over the other for elders is lacking. 
In this pilot trial, we will test real‐world, practice‐based strategies comparing traditional treatment 
to treatment including incretin-based drug classes in reducing glycemia safely in diabetic elders in 
the short run (3‐6 months).   
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Design Overview: This study will be a single center, randomized controlled trial (RCT) with 2 
parallel arms. The participants will be 30 adults age 65 or older with type 2 diabetes mellitus. After 
informed consent and screening, these elderly adults will be randomly assigned to one of two anti-
diabetic regimens (both regimens use only FDA-approved medications):  
 
1) 
a regimen with traditional drugs only (e.g. insulin, metformin, sulfonylureas, TZDs); or 
2) 
a regimen including incretin-baseder drugs (e.g. GLP-1 analogues and receptor agonists, 
DPP-4  inhibitors, amylin analogues).  
 
The primary outcome variable is time to achieve glycemic target (HbA1c <7.5%). Secondary 
outcomes are overall hypoglycemia, weight, diabetes quality of life, and adverse events. 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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Version 3 Dated:   06/2007 
 
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Setting: The setting for this trial will be MODEL Clinical Research (MODEL) affiliated with Bay 
West Endocrinology Associates and now part of the Johns Hopkins Clinical Research Network 
(JHCRN). This practice sees private patients and also covers the Greater Baltimore Medical Center 
(GBMC) .  
 
Recruitment: We will have a rolling recruitment and anticipate we will recruit, randomize, and 
follow 30 participants in 8 months. We aim to recruit 30% or more African American or Hispanic. 
As part of the recruitment process, we will first search the existing Bay West Endocrinology 
database to identify potential patients. Then, with approvals from their providers, we will contact 
potential patients when they come in the office to see their providers. IRB-approved recruitment 
flyers will also be placed in the Bay West Endocrinology office, including lobby, check in/out and 
exam rooms. We do not plan to initiate recruitment by phone. However, if patients call or leave 
message, the study coordinator will call back based on the IRB approved telephone script.  
 
Informed Consent: To participate in GLiDE Trial, participants must provide written, informed 
consent using procedures reviewed and approved by the Johns Hopkins Institutional Review Board.  
 
Data Collection Visits: Screening, baseline, and follow-up data will be collected at in-person visits 
at MODEL or phone calls. Table 1 presents the data collection schedule by visit. 
 
 
 
Screening Visit (SV): After being identified as part of the recruitment process, there will be a SV 
to determine eligibility and commitment to the study. Interested persons will attend one visit at 
which the trial is described in detail, all patient questions are answered, written informed 
consent obtained, and physical measurements performed. Demographic and contact information, 
 
SV 
RV 
FV1 
Call 
FV2 
Call 
FV3 
Months 
― 1 
0 
1 
1.5 
3 
4.5 
6 
Informed consent 
■ 
 
 
 
 
 
 
Contact information 
■ 
 
 
 
 
 
 
Intervention 
 
■ 
■ 
 
■ 
 
 
Randomization 
 
■ 
 
 
 
 
 
Blood Pressure 
 
■ 
■ 
 
■ 
 
■ 
Weight 
 
■ 
■ 
 
■ 
 
■ 
Waist 
 
■ 
 
 
 
 
■ 
Height 
■ 
 
 
 
 
 
Fasting  blood work† 
 
■ 
 
 
■ 
 
■ 
Fructosamine 
 
■ 
■ 
 
 
 
■ 
HbA1c 
 
■ 
 
 
■ 
 
■ 
Questionnaires 
 
Demographic/ Medical history 
■ 
 
 
 
 
 
Medication Use 
■ 
■ 
■ 
■ 
■ 
■ 
EQ-5D Health Status Patient questionnaire 
■ 
 
 
■ 
 
■ 
Diabetes Quality of Life questionnaire 
■ 
 
 
■ 
 
■ 
Diabetes Distress Screening Scale – 2 items 
■ 
 
 
■ 
 
■ 
Self care  
■ 
 
 
■ 
 
■ 
Incontinence – 1 item 
■ 
 
 
■ 
 
■ 
†Including lipids and glucose 
Phone calls at 1.5 and 4.5 month to check in. 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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medication use, and medical history will be obtained. To maximize the generalizibility of the 
trial results, there will be no run-in period in this study.  
 
Randomization Visit (RV): Upon confirmation of eligibility and informed consent process, 
weight, height, waist circumference, and blood pressure will be measured according to standard 
research protocols. Screening Visit and Randomization Visit can be combined. Patients will 
complete the study questionnaires. Fasting blood work will be completed during the same visit 
or the participants can come back in a few days. Participants will then be randomized into one 
of the two groups. 
 
Follow-Up Visits (FVs): Participants will be asked to attend in-person follow-up visits at 1 
month (FV1), 3 month (FV2), and 6 (FV3) months after randomization and will receive a phone 
call at 1.5 month and 4.5 month. The total intervention period is 6 months. 
 
 
Interventions: Under the leadership of Dr. Levin, the primary investigator at MODEL, a panel of 7 
experts in endocrinology (Drs. James Mersey at MODEL & BAY and Tom Donner at JHSOM 
Endocrinology), primary care (Drs. Frederick Brancati of Hopkins GIM Division and Gary Noronha 
at JHCP), and geriatrics (Drs. Elbert Huang at U of Chicago and Cynthia Boyd at JHSOM 
Geriatrics) has convened and developed the clinical algorithms for each treatment group. Table 2 
outlines the proposed regimens for the two treatment groups. Please refer to Appendix 1 for detailed 
interventions and Appendix 2 for a list of potential medications. Traditional drugs listed in the 
Standard Treatment Group are widely used in current clinical practice. The Incretin-based Drug 
Treatment Group is adapted from the 2010 AACE Consensus Statement. The patient’s primary 
endocrinologist will follow the randomly assigned algorithm to provide treatment as part of 
patient’s routine diabetes care. Participants in both groups will receive the same dietary and lifestyle 
advice based on the American Diabetes Association Standard of Care 2012 guideline. Baseline 
medications will not be discontinued unless due to adverse event or contraindication developing. 
Incretin- based arm will not discontinue baseline medications, either, unless addition of 
intensification drug triggers clinical indication to discontinue DPP-4 or SU. There will be 
medication overlap between groups as all patients start with oral agents or basal insulin +/- orals 
regardless of study arm. However, the standard group will not use injectable incretins and will use a 
DPP4 Inhibitor only as a last resort oral agent if other oral agent additions are not clinically 
indicated in a given patient. At the end of each study visit, the study coordinator will review current 
treatment plan to ensure protocol adherence by physician and patient. Investigators at MODEL will 
review status of each study patient with coordinator at weekly research meeting.  
 
 
 
 
 
 
 
 
 
 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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Version 3 Dated:   06/2007 
 
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Table 2. Proposed regimens for two treatment groups (Refer to Appendix for detailed interventions) 
 
Standard Treatment Group 
 
 Incretin-based Treatment Group 
Baseline; HbA1c 8% - 12% 
 
On one of more oral 
meds 
On basal insulin +/- 
orals 
On one of more oral 
meds 
On basal insulin +/- 
orals 
Add one more oral:  
Metform, 
Sulfonylureas, or  
TZD (i.e.Actos) 
Intensify basal, or add 
bolus 
  
If not on DPP-4, add 
DPP-4 or start GLP-1 
and decrease SU. 
 
If already on DPP-4, 
then discontinue DPP-
4, add GLP-1 
and decrease SU 
 
Add GLP-1, decrease 
SU 
 
If already on DPP-4, 
then discontinue DPP-
4, add GLP-1, and 
decrease SU.   
 
Self-directed basal 
insulin titration (3-0-3 
scheme) until visit 2 
 
 
FV 2 (3 month visit) 
 
HbA1c 
>7.5% 
HbA1c 
<=7.5 
HbA1c 
>7.5 
HbA1c 
<=7.5 
HbA1c 
>7.5% 
HbA1c 
<=7.5 
HbA1c 
>7.5 
HbA1c 
<=7.5 
Add 
basal or 
oral(s) if 
not at 
max 
Continue 
regimen 
Intensify 
Basal/Bol
us 
 
Continue 
regimen 
Add 
basal 
Continue 
regimen 
Basal/Bol
us 
 
Continue 
GLP-1 
 
Continue 
regimen 
 
 
FV3 (6 month visit) 
 
Obtain final HbA1c and other outcomes 
 
 
b. Study duration and number of study visits required of research participants. 
 
The study duration is 6 months.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Upon confirmation of study eligibility, signed informed consent form, and the baseline data 
collection, 30 participants will be randomized in a 1:1 ratio to one of the two groups. 
Randomization will be in variable blocks (2 and 4) after stratification by age (65 to 74; vs 75 and 
older), using the Moses-Oakford algorithm, adapted for SAS statistical software. The randomization 
scheme will be generated by the Statistician and the Study Coordinator will convey actual 
randomization assignment to participants. Trial participants will know their intervention 
assignments, as will intervention physicians. However, study staff involved in follow-up data 
collection will be kept masked to participants’ randomization assignments. 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
N/A. Patients will receive routine diabetes care 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
Not applicable. 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants can be removed from study by Dr. Philip Levin, the leader of clinical intervention at 
any time without patient consent for any of the following reasons: (1) if the participant fails to 
follow directions for participation in the study; (2) if a specific FDA-approved diabetes regimen 
appears harmful to participant; or (3) if the study is cancelled. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
Participants will remain under the care of their personal physician both during the study and 
after the study ends. 
 
5. 
Inclusion/Exclusion Criteria 
 
Patient inclusion criteria: 
 
Type 2 diabetics diagnosed for at least 6 months 
 
Patients ages ≥ 65 years and older 
 
Active patients in the Bay West Endocrinology practice 
 
Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 
12% 
 
Eligible for randomization to either treatment group 
 
Patients willing to follow either treatment arm including regimen using one or more 
injectables 
 
Patients to have an English Reading Level of Grade 6 or above 
 
Patients residing at home 
 
Patient exclusion criteria: 
 
Unwilling to use a regimen that may contain using one or more injections 
 
Using short acting insulin prior to the study   
 
Using GLP-1 in past 10 weeks 
 
History of hypoglycemia unawareness or episodes needing emergency intervention 
 
End-stage renal disease 
 
Dementia 
 
Blindness 
 
Terminal illness 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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 
Judged by investigators as unlikely to follow protocol because of known non-compliance, 
psychiatric disease, alcohol or drug abuse. 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
The study objective is to compare the effectiveness of two diabetes treatment strategies 
(regimen using FDA approved traditional diabetes drugs only vs. regimen including incretin-
based classes of FDA approved diabetes medication) in elderly patients with type 2 diabetes. All 
of these diabetes drugs are FDA approved for standard use.  
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
 
This study will use FDA approved drugs for diabetes treatment. 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
 Not applicable. 
 
7. 
Study Statistics 
a. Primary outcome variable. 
 
Time to achieve glycemic target (HbA1c <7.5%). This goal will be defined as HbA1c measures at 
follow-up visits.  
 
b. Secondary outcome variables. 
 
Secondary Outcomes: a) Percent achieving glycemic target at 6 month; b) Overall hypoglycemia 
measured by glucose meter; c) Total cholesterol, HDL cholesterol, and triglyceride; d) Fasting 
glucose insulin, and fructosamine; e) blood pressure (BP) and heart rate determined by the OMRON 
907-XL; f) Weight, height, and waist circumference; g) EQ-5D Questionnaire; h) Diabetes Quality 
of Life Questionnaire14; i) Diabetes distress15 (2 screener questions); j) self-care; k) incontinence16 
(1 question).  
 
Other Data: a) Demographics: tobacco use, health insurance status, education level, and live alone 
status; b) Medication history including monitoring adherence, which will be self-reported for each 
of the prescribed medications for glycemic control.  
 
Adverse Events: Hypoglycemic episodes requiring assistance by medical/paramedical personnel, 
overnight hospitalization, diabetes-related deaths, and other outcomes that the Medical Monitor 
deems important. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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Version 3 Dated:   06/2007 
 
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One of the purposes of this pilot trial is to collect needed parameters for future planning of a larger 
scale confirmatory RCT. To this end, the frequency distribution of parameters of interested will be 
collected and described at baseline and over follow-up. Repeated measures over follow-up will 
provide estimate for intra-individual correlations that will be needed in sample size/power 
determination for the future trial. Repeated measures of HbA1c will also allow examination of 
HbA1c trajectory over time to inform the feasibility of interpolate the time to reaching HbA1c 
target threshold based on fixed interval assessments. 
 
Using width of 95% CI as a measure of precision in parameter estimation, a sample size of 30 will 
provide estimation precision of ± 0.31xSD for a continuous variable, ± 15.5% for a binary 
proportion of 50%, and ± 9.3% for a binary proportion of 10%. For subgroup estimation with N = 
15 per group, the above precision will be inflated by 1.4. 
 
d. Early stopping rules. 
 
Formal stopping rules are not planned for this pilot trial.   
 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
This study uses FDA-approved drugs and regimens in routine clinical settings. Being a part of this 
study does not in itself increase any medical risks to participants as the risks are the same risks that 
participants have while being treated with any diabetes drugs by their own physicians. These 
standard FDA-approved diabetes regimens used here will also not increase risk of hypoglycemia 
beyond those risks found in standard clinical practices. Closer monitoring by study staff could 
minimize hypoglycemic risk during this trial. Potential participants will be provided with more 
detailed information about all of the possible risks and discomforts of the specific diabetes drugs 
that are given to them.  
 
b. Steps taken to minimize the risks. 
 
This study will follow participants more closely than they would typically be followed by their own 
physicians in routine clinical practice. Hypoglycemic risk and adverse effect in particular should be 
mitigated by closer than typical observation by medical/study staff. See Section x related to 
protection of data confidentiality.  
 
c. Plan for reporting unanticipated problems or study deviations to the JHM IRB. 
 
Adverse Events required to be reported to the JHM IRB are defined as those events that are serious, 
unexpected and associated with the FDA-approved ‘study’ medications (Medications used as part of 
this study, also known as study medications, are all FDA-approved diabetes medications.)  Serious 
will be defined using the FDA’s description of “serious”. 
 
Participants in the GLIDE Study are expected to have medical events due to disease, which 
typically can occur in this elderly study population and are not associated with the FDA-approved 
medications that patients will receive in this study. Events exempted from IRB reporting, i.e. events 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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due to progression of an existing disease, development of a new disease, treatments, procedures or 
hospitalization for these diseases, or known side effects or concomitant therapies, other than the 
FDA medications, received by these patients.  These events are exempted from the usual JHM IRB 
SAE reporting requirements, i.e. will not be reported individually to JHCRN and/or JHM IRB 
during the conduct of the study unless they are reported as drug related SAEs by the investigator. 
 
All serious adverse events will be documented in patient’s study chart, collected as part of study 
procedures and also reported to Medical Monitor; however, only those that meet the criteria that are 
serious, unexpected, and associated with the FDA-approved study medications will be reported to 
both JHU/GBMC IRBs within 10 working days.  If in doubt about whether or not the event meets 
the criteria of serious, unexpected and associated with the FDA-approved diabetes medications, it 
will be up to the JHU Principal Investigator to make the final determination after consulting with at 
least 1 of the study’s sub-investigators. 
 
Safety Monitoring Plan 
There will be no formal Data and Safety Monitoring Board (DSMB) for this pilot trial using FDA-
approved medications in the manner that they were approved for the patient population that FDA 
approved. Patients will remain under their own physicians’ care. Dr. Tom Donner  at Johns 
Hopkins, will serve as Medical Monitor for the study and for serious and unexpected adverse 
events. As stated in section 8c. of this protocol, all serious adverse events will be documented in 
patient’s study chart, collected as part of study procedures, and also be reported to Medical Monitor 
Principal Investigator.  All other AEs will be logged and submitted to the IRB at Continuing 
Review.   
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
The investigative team and MODEL are keenly aware of the need to protect participant 
confidentiality, as well as corresponding legal requirements, including those mandated by 
HIPAA (Health Insurance Portability and Accountability Act).  All data collected and stored 
electronically will be password protected and saved in a secured fashion. All study related 
computers will be under firewall protection and will maintain automated virus update 
mechanisms. Timely notification regarding relevant patches will be provide. Hard copy of the 
data collection forms will be store in locked cabinets or areas. Only authorized personnel will 
have access to these locked areas. In addition, all study staff annually sign a confidentiality 
statement attesting to their understanding of, and willingness to abide by, the staff written 
policies on research ethics and confidentiality. Access to the data entry system is password 
protected and restricted to personnel trained to use the system. 
 
e. Financial risks to the participants. 
There will be no financial risks to the participants. The clinical care will be a part of the routine 
medical care and the cost of medication will be covered through patient’s own insurance plan 
and/or by patient’s own funds.  
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 


Date: June 11, 2013 
Principal Investigator: Hsin-Chieh Yeh, PhD 
Application Number: NA_00052707 
 
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Participants will receive additional medical monitors from study visits and phone call.  From a 
societal perspective, if this pilot study is successful, it will set the stage for a large-scale trial that 
should provide a solid evidence base for decision-making about diabetes treatment in elders. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
A participants will receive a total of $80 if he/she complete the study, which includes  $20 for 
baseline visit, the interim visits (4 weeks and 12 weeks) and final visit (including questionnaires. 
Parking will be reimbursed. There will be no penalties for not completing protocol.  
 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
The cost of medications will be covered through patient’s own insurance plan and/or by 
patient’s own funds. All the medications used in this trial are eligible for reimbursement by 
Medicare and major insurance companies. If insurer denies use of a given drug category or 
patient is without insurance, then medication will be supplied by this study at no cost for the 
duration of study. There will be no charge for blood tests, interviews, or physical 
measurements that are for research purposes only. 
 
 
REFERENCES 
 
1. Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related 
costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. PubMed PMID: 19940225; PubMed Central 
PMCID: PMC2782981. 
 
2. Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, Marinopoulos SS, Puhan MA, 
Ranasinghe P, Block L, Nicholson WK, Hutfless S, Bass  EB, Bolen S. Comparative Effectiveness and 
Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2-Drug Combinations. 
Ann Intern Med.  2011 Mar 14. [Epub ahead of print] PubMed PMID: 21403054. 
 
3. Yeh HC, Huang ES, Levin P, Liu SH, Brancati FL. Medication Use in Elderly US Adults with Diabetes 
and the Potential Practice Ramifications of Raising the Glycemic Target, NHANES 2003-08. Accepted for 
oral presentation at American Diabetes Association Scientific Meeting, June 2011, San Diego. 
 
4. UK Prospective Diabetes Study Group: Tight blood pressure control and risk of macrovascular and 
microvascular complications in type 2 diabetes (UKPDS 38). BMJ 317:703–713, 1998 
 
5. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose 
lowering in type 2 diabetes. NEngl J Med 2008;358:2545-2559  
 


Date: June 11, 2013 
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Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD, VADT 
Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 
2009;360:129 – 139 
 
7. Brown AF, Mangione CM, Saliba D, Sarkisian CA: Guidelines for improving the care of the older 
individual with diabetes mellitus. J Am Geriatr Soc 51 (Suppl.): S265–S280, 2003 
 
8. Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP Jr, Selby JV. Hypoglycemic episodes and risk of 
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