Clinical trial NCT04623086
Conditions: Type 1 Diabetes
Keywords: Insulin glargine, insulin degludec
Sponsor: University of Washington
Start date: 2020-02-14; Completion date: 2023-12-31
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates direct switching vs use of a bridging dose from insulin glargine to insulin degludec in type 1 DM patients. Half of the participants will receive a bridging insulin glargine dose along with the 1st dose of degludec, while other half will receive a placebo and 1st dose of degludec.

Detailed description:
Insulin degludec (IDeg), an ultra-long-acting basal insulin, is increasingly used to treat patients with type 1 diabetes (T1D). IDeg has a half-life of 25 hours and duration of action exceeding 42 hours in patients with T1D and as a result does not require as stringent a dosing schedule as other basal insulins. However, steady state concentration of IDeg is not reached until 2 to 3 doses are administered daily, and this may result in greater glycemic variability in the 24 to 72 hours following the initiation of therapy with IDeg.

Our hypothesis is that among patients who transition from insulin glargine to IDeg, those who use a bridging dose of insulin glargine will not have a significant change, on average, in time spent in target glycemic range during the transition period, whereas, those transitioning directly to IDeg will have a significant change in this parameter. We further hypothesize that those using the bridging dose of insulin glargine will have less hypoglycemia, less hyperglycemia and need fewer correction boluses than the direct-conversion patients during the transition period.

Though IDeg is being increasingly used in clinical practice, there are no guidelines on what is the best way to transition patients from other long-acting insulins, such as glargine, to IDeg. The package insert recommends 1:1 dose conversion from other basal insulins to IDeg, but this does not account for the time taken by IDeg to achieve steady state (typically 48-72 hours). There is no guidance on what to do in those 48-72 hours. Given the time taken for IDeg to achieve steady state, the period of transition from one insulin to another, can result in significant glycemic variation in the 24-72 hours after the first dose. We want to study how best to avoid or minimize this and the option of using a small dose of their original long-acting insulin has anecdotal evidence of success in our practice.

Arms: arm 1: Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily arm 2: Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Interventions: intervention 1: Insulin Degludec intervention 2: Insulin Glargine intervention 3: Placebo
Intervention descriptions: intervention 1: Insulin Degludec injection intervention 2: Insulin Glargine injection intervention 3: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection

Protocol documents:
Prot_SAP_002.pdf: 
Brief Title: Comparison of Glargine to Degludec Insulin Transition With or Without a 
Bridging Glargine Dose ( GLIDING ) 
 
Official Title: A Randomized Comparison of Transitioning From Insulin GLargine to Insulin 
Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in 
Patients With Type 1 Diabetes Mellitus - a Pilot 
StudyNCT number: NCT04623086 
PI Name: Arthi Thirumalai MD 
Document name: Protocol 
IRB approval date: 08/13/2020


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A randomized comparison of transitioning from insulin 
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GLargine to Insulin Degludec usING a bridging dose of 
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glargine versus direct conversion, in patients with type 1 
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diabetes mellitus – a pilot study 
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(GLIDING STUDY) 
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INVESTIGATOR-SPONSORED STUDY PROPOSAL 
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UNIVERSAL TRIAL NUMBER (UTN): U1111-1214-3257 
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Arthi Thirumalai, MBBS, Jing H. Chao, MD, Irl B. Hirsch, MD. 
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Division of Metabolism, Endocrinology and Nutrition 
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Department of Medicine 
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University of Washington 
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1959 NE Pacific St, Box 356426, Seattle, WA 98195 
 
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Correspondence to: 
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Arthi Thirumalai 
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Assistant Professor 
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1959 NE Pacific St, HSB C-209 
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UW Box # 357138, Seattle, WA 98196 
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Phone: 206-221-0521, Fax: 206-616-0499 
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Email: arthidoc@uw.edu 
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Table of Contents 
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1. 
BACKGROUND AND SIGNIFICANCE ................. Error! Bookmark not defined. 
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2. 
SPECIFIC OBJECTIVES ........................................................................................... 4 
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3. 
RESEARCH DESIGN AND METHODS ................................................................... 5 
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3.1 
Study Hypothesis .................................................................................................. 5 
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3.2 
Endpoints ............................................................. Error! Bookmark not defined. 
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3.3 
Study type ............................................................................................................. 5 
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3.4 
Rationale for study Design ................................................................................... 6 
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3.5 
Study population: ................................................................................................. 7 
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3.6 
Inclusion Criteria .................................................................................................. 7 
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3.7 
Exclusion Criteria ................................................................................................. 7 
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3.8 
Withdrawal Criteria .............................................................................................. 8 
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3.9 
Patient Replacement ............................................................................................. 9 
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3.10 
Rationale for Study Population. ........................................................................ 9 
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3.11 
Visit Procedures ................................................................................................ 9 
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3.11.1 Screening Visit (Visit 1) ............................................................................. 10 
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3.11.2 CGM insertion visit (Visit 2) ...................................................................... 11 
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3.11.3 Telephone Encounters #1 ............................................................................ 13 
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3.11.4 Telephone Encounter #2: ............................................................................ 13 
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3.11.5 Telephone Encounter #3: ............................................................................ 13 
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3.11.6 CGM Removal and Download Visit (Visit 3) ............................................ 14 
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3.11.7 Exit Visit/Telephone encounter #4 (Visit 4) ............................................... 14 
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3.12 
Assessments for Efficacy ................................................................................ 14 
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3.13 
Assessments for Safety ................................................................................... 15 
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3.14 
Patient Compliance ......................................................................................... 15 
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4. 
STATISTICAL CONSIDERATIONS ...................................................................... 16 
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5. 
DATA HANDLING AND RECORD KEEPING: .................................................... 16 
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6. 
ETHICS..................................................................................................................... 17 
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7. 
STUDY SCHEDULE................................................................................................ 17 
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7.1 
Study Schedule ................................................................................................... 18 
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7.2 
Study Milestones ................................................................................................ 19 
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8. 
STUDY DRUGS AND MATERIALS ...................................................................... 19 


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8.1 
Study medication(s) / devices(s) ........................................................................ 19 
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8.2 
Packaging and Labelling of Study Medication(s) .............................................. 19 
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8.3 
Storage and Drug Accountability of Study Medication(s) ................................. 20 
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8.4 
Auxiliary Supply ................................................................................................ 20 
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8.5 
Randomization and Blinding .............................................................................. 21 
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8.6 
Breaking of Blinded Codes ................................................................................ 21 
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9. 
CONCOMITANT ILLNESSES AND MEDICATIONS .......................................... 21 
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9.1 
Definitions .......................................................................................................... 21 
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10. 
ADVERSE EVENTS ............................................................................................. 22 
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10.1 
Definitions ...................................................................................................... 22 
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10.1.1 Adverse Event (AE) .................................................................................... 22 
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10.2 
Severity Assessment Definitions .................................................................... 23 
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10.3 
Relationship to study medication Assessment Definitions ............................. 23 
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10.4 
Outcome Categories and Definitions .............................................................. 23 
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10.5 
Collection, Recording and Reporting of Adverse Events ............................... 23 
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10.6 
Follow-up of Adverse Events ......................................................................... 24 
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10.7 
Pregnancy ....................................................................................................... 25 
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10.8 
Precautions/Over-dosage ................................................................................ 25 
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11. 
LIABILITY AND SUBJECT INSURANCE ......................................................... 25 
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12. 
EVALUABILITY OF SUBJECTS ........................................................................ 26 
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13. 
PREMATURE TERMINATION OF STUDY: ...................................................... 26 
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14. 
PUBLICATION PLAN .......................................................................................... 27 
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15. 
REFERENCES ...................................................................................................... 28 
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1. BACKGROUND AND SIGNIFICANCE: 
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Insulin degludec (IDeg), an ultra-long-acting basal insulin, is increasingly used to 
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treat patients with type 1 diabetes (T1D). IDeg has a half-life of 25 hours and 
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duration of action exceeding 42 hours in patients with T1D (1,2) and as a result does 
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not require as stringent a dosing schedule as other basal insulins. It has been shown 
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to have a 4-fold lower within-patient variability in its pharmacodynamic response 
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compared   to  insulin   glargine  over  the  24  hour  dose  interval   (3).  The  rate  of 
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symptomatic and severe hypoglycemia in T1D patients has also been shown to be 
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lower with IDeg than insulin glargine (4). A recently published systematic review 
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and meta-analysis of 15 clinical trials comparing IDeg to insulin glargine showed 
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lower fasting plasma glucose and less nocturnal hypoglycemia with IDeg (5). The 
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total basal insulin dose invariably decreases with the transition to IDeg (6,7). The 
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lower  insulin  use  and  lower  rate  of  hypoglycemia  may  eventually  translate into 
116 
medical cost savings too (8). Moreover, patients have expressed more satisfaction 
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with their regimen and quality of life with IDeg compared to other agents in one 
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study that compared this objectively using questionnaires, before and after transition 
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(9). All of these factors give IDeg an advantage over other basal insulins currently in 
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the market. However, steady state concentration of IDeg is not reached until 2 to 3 
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doses are administered daily, and this may result in greater glycemic variability in 
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the  24  to  72  hours  following the  initiation  of  therapy with  IDeg (10).  There   is 
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currently no evidence-based guidance on how to minimize glucose excursions when 
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transitioning patients from their existing basal insulin to IDeg. The package insert for 
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IDeg suggests a 1:1 dose conversion from other basal insulin regimens to IDeg for 
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adult patients. However, this does not account for the time it takes IDeg to achieve 
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steady state and can result in worsening of glycemic control in the 48-72 hours after 
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the transition is made. Many practitioners at the University of Washington Diabetes 
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Clinic have seen better glycemic control within the first 12 to 24 hours in T1D 
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patients in whom we gave 50% of their usual dose of insulin glargine at bedtime 
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along with the first dose of IDeg. This leads to our hypothesis that a bridging therapy 
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involving the use of a reduced amount of patients’ prior basal insulin at the time of 
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initiating IDeg will lead to improved glycemic control in the first 24-72 hours on 
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IDeg, minimizing the morbidities associated with hyperglycemia and the need for 
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correctional insulin and also avoiding hypoglycemia resulting from over-correction 
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due to use of additional rapid-acting insulin. Additionally, we will follow what has 
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been done in prior clinical trials of conversion from other basal insulins to IDeg and 
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hence, convert them from their insulin glargine total daily dose to 80% of that dose 
139 
as IDeg (4). An improvement in the safety and ease of transitioning from the more 
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commonly used glargine to IDeg may greatly encourage more providers and patients 
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to adopt IDeg as the basal insulin of their choice. Another benefit would be knowing 
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how to transition patients back to their outpatient IDeg therapy when they are being 
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discharged home from an inpatient stay and were switched to insulin glargine during 
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their hospitalization, as IDeg is not formulary in many hospitals. The purpose of this 
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pilot study is to gain preliminary evidence of whether bridging with insulin glargine 
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while transitioning to IDeg provides better glycemic results in the transition period 
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compared to direct conversion. 


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2. ENDPOINTS AND OBJECTIVES: 
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Primary endpoint: 
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Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both 
152 
values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg 
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Primary objective: 
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To  compare  the  mean  change  in  percent  time  in  range  (as  defined  by  the  primary 
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endpoint) between patients who transition directly to IDeg to the mean change in patients 
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who use a bridging dose of insulin glargine along with 1st dose of IDeg. 
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Secondary end points: 
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These will include the following data obtained from their CGM download in the 48 hours 
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following the first dose of IDeg as measured as a difference compared to the 48 hours 
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preceding the dose: 
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1. Coefficient of variation of percent-time-in-range for each treatment within 
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each group 
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2. Nocturnal time in range of 70-180 mg/dL (between mid-night and 0600 hours, 
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both values included) 
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3. Percent time above 180 mg/dL (TAR-1), percent time above 250 mg/dL 
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(TAR-2) for each treatment within each group 
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4. Percent time below 70 mg/dL (TBR-1), percent time below 54 mg/dL (TBR- 
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2) for each treatment within each group 
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5. Number of correction boluses for each treatment within each group 
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Secondary objectives: 
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To compare each of the secondary endpoints between patients who use a bridging dose to 
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patients who transition directly to IDeg. 
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3. RESEARCH DESIGN AND METHODS 
 
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3.1 
Study Hypothesis: 
178 
Our hypothesis is that among patients who transition from insulin glargine to IDeg, those 
179 
who use a bridging dose of insulin glargine will not have a significant change, on average, 
180 
in  time  spent  in  target  glycemic  range  during  the  transition  period,  whereas,   those 
181 
transitioning directly to IDeg will have a significant change in this parameter. We further 
182 
hypothesize  that   those   using  the  bridging  dose  of  insulin   glargine   will   have less 
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hypoglycemia, less hyperglycemia and need fewer correction boluses than the direct- 
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conversion patients during the transition period. 
 
185 
3.2 
Study type: 
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This   will   be   a   double-blind,   randomized,   single-center,   proof-of-concept   study. 
188 
Randomization will be stratified by use of insulin glargine once daily or twice daily at 
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baseline. Randomization will be conducted using permuted-block design with a block 
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size of 4, ensuring equal numbers of bridging and non-bridging patients in each of the 2 


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resultant strata after every 4th patient is randomized within a stratum. The 2 strata with 
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blocked randomization within each stratum will result in 4 groups as follows: 
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1. Bridging Groups: 
194 
i. 
Patients transitioning from once daily insulin glargine to once daily IDeg with 
195 
a bridging dose of insulin glargine. 
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ii. 
Patients transitioning from twice daily insulin glargine to once daily IDeg 
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with a bridging dose of insulin glargine. 
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2. Direct-Conversion Groups: 
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i. 
Patients transitioning from once daily insulin glargine to once daily IDeg 
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without a bridging dose of insulin glargine (but with a bridging dose of 
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placebo solution to preserve blinding). 
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ii. 
Patients transitioning from twice daily insulin glargine to once daily IDeg 
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without a bridging dose of insulin glargine (but with a bridging dose of 
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placebo solution to preserve blinding). 
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All patients will be instructed to use their own prescription insulin medications till before 
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the 1st  dose of IDeg. On the night they have to transition to IDeg, they will start using 
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study drugs for their basal insulin (see section 3.10.4). Starting with the 1st dose of IDeg, 
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their basal insulin will be from study drug only, till visit #3 (see section 3.10.6), at  which 
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time, they will resume their original insulin prescriptions. They will remain on their own 
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prescription short-acting insulin throughout the study. On the night of the transition, all 
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patients will be instructed to take their 1st  dose of IDeg and along with this, they will take 
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a second injection from a pre-filled syringe of a pre-specified dose of insulin glargine or 
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matched placebo (normal saline), that participants will collect from Investigational Drug 
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Services Pharmacy (IDS) on the same day. The dose will be calculated ahead of time by 
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study staff on  visit 2 (see under  section 3.10.2.1). Neither  the patients, nor the  research 
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staff will be aware of their randomization, which will be done by IDS. Patients will act as 
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their own controls, as we will collect glycemic data from 48 hours prior to the first dose 
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of IDeg, which will be compared to the data seen in the 48 hours after the first dose of 
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IDeg. During this observation period of the 48 hours before and after the first dose of 
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IDeg, no adjustments will be made to the calculated and recommended doses of insulin 
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glargine or IDeg. Patients will be followed for up to 1 week after the first dose of IDeg. 
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3.3 
Rationale for study Design 
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Though IDeg is being increasingly used in clinical practice, there are no guidelines on 
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what  is  the  best  way  to  transition  patients  from  other  long-acting  insulins,  such  as 
227 
glargine, to IDeg. The package insert recommends 1:1 dose conversion from other basal 
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insulins to IDeg, but this does not account for the time taken by IDeg to achieve steady 
229 
state (typically 48-72 hours). There  is no  guidance on  what  to do in  those 48-72 hours. 
230 
Given the time taken for IDeg to achieve steady state, the period of transition from one 
231 
insulin to another, can result in significant glycemic variation in the 24-72 hours after the 
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first dose. We want to study how best to avoid or minimize this and the option of using a 
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small dose of their original long-acting insulin has anecdotal evidence of success in our 
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practice. 
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3.4 
Study population: 
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We aim to recruit patients with type 1 diabetes mellitus only. We will screen 50 patients 
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with  the  plan  to  randomize  approximately 40  patients  to  start  IDeg.  The  IDS  at the 
239 
University of Washington will randomize patients (1:1) to either receive or not receive a 
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bridging insulin glargine dose along with the 1st  dose of IDeg, within the stratified groups 
241 
of once- or twice-daily insulin-glargine regimens. 
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3.5 
Inclusion Criteria 
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Patients must meet ALL inclusion criteria to be included in the study. 
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1. Patient age is 18-75 years. 
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2. Diagnosis of T1D of at least 1-year duration. 
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3. Has the ability to provide informed consent before any trial-related activities. 
248 
4. Treated with insulin glargine as their basal insulin in the 3 months preceding 
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screening visit. 
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5. Stable insulin regimen (defined as change of <20% in the total daily dose of 
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insulin and no change to the basal insulin agent) over the 3 months preceding the 
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screening visit. 
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6. Patient willing to dose their basal insulin at bedtime. 
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7. Hemoglobin A1c < 9% in the 3 months preceding screening visit. 
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8. Able to self-administer their insulin doses. 
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9. Able to do self-monitoring of blood glucose using a glucose meter and willing to 
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do this at least 2 times daily for patients using a CGM that requires calibration 
258 
prior to the study and 4 times daily for patients who were not using a CGM prior 
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to the study. 
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10. Agreeable to the use of a continuous glucose monitor (CGM) for the duration 
261 
required in the study. If already using a CGM prior to the study, then agreeable to 
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wearing the blinded study CGM concurrently during the study period. 
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11. Will be reachable by phone and/or email to comply with study procedures. 
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12. Will be able to comply with study procedures, per investigator’s opinion. 
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13. Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours 
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before and after 1st dose of IDeg. 
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3.6 
Exclusion Criteria 
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Patient must not have ANY of the exclusion criteria to be included in the study. 
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1. Patients with eGFR <30 on at least 2 measurements within 1-year of the screening 
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visit. 
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2. History of myocardial infarction within 6 months preceding the screening visit. 
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3. Patients taking non-insulin medications for the glycemic management of T1D 
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(including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 
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inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide) 
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4. Known or suspected allergy to IDeg or one of its excipients. 
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5. Pregnant, planning to become pregnant in the next 3 months or breastfeeding. 
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6. Participation in a clinical trial with investigational drug within 1 month of the 
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screening visit or at present. 


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7. Skin condition that prevents the insertion of the CGM. 
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8. Previously randomized and received drug in this study. 
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9. Presence of decompensated or poorly controlled psychiatric conditions. 
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10. Current known or suspected illicit substance use. 
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11. Any anticipated surgery or procedure in the next 14 days. 
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12. Patients using U-300 glargine as their basal insulin. 
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13. Patients using insulin afrezza as their short-acting insulin. 
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14. Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit 
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(chronic stable glucocorticoid doses are acceptable). 
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3.7 
Withdrawal Criteria 
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Patients have the right to withdraw from the study at any stage and for any reason. 
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Patients may be discontinued prematurely, by the investigator for any of the following 
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reasons: 
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• Emergence of a severe condition(s) such that, in the judgement of the investigator, 
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continuation in the trial would negatively impact the health of the patient. 
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• Lack of compliance with study medication or visits as judged by the Investigator. 
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• Patient lost to follow-up. 
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• Major protocol violation. 
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• Inter-current illness that, in the judgment of the investigator, should result in 
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premature discontinuation. 
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• Use of prohibited medications (see the Inclusion/Exclusion criteria) 
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• Onset of glucocorticoid burst/pulse therapy during the study period. 
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• Knowledge of new risks necessitating new benefit/risk evaluation. 
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• Patient voices intention to become pregnant in the immediate future. 
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Patients must be discontinued for any of the following reasons: 
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• If Novo Nordisk determines that the study must be stopped, all patients will be 
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required to end participation at that time. 
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• Trial closed-out. 
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• Patient becomes pregnant. 
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A patient will not be discontinued early from the study solely because of missing the 
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scheduled transition from insulin glargine to IDeg. The research staff will discuss the 
315 
matter with the patient and determine whether they feel he/she can continue moving 
316 
forward  in  the  study  following  all  study  procedures,  including  dosing.  If  after  this 
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discussion, the patient and the research team are in agreement about continuing in the 
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study, the investigator will decide if he/she may remain in the study. 
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A subject cannot be considered lost to follow-up until the research center performs and 
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documents at least three (3) attempts to contact him by phone, email or letter. 
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3.8 
Patient Replacement 
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Patients  discontinuing from  the study will  not be replaced.  IDS  will  continue to assign 
325 
randomization   of  the  next   participant   to   a  specific   group,   based   on the original 
326 
randomization plan, when the next participant has completed screening procedures and is 
327 
ready for randomization. We will include data from all randomized participants in our 
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data analysis. 
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3.9 
Rationale for Study Population 
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The main objective of our study is to determine if the use of a bridging dose of insulin 
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glargine is able to improve glucose control in first few days after the first dose of IDeg. 
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As  a  result,  we  will  recruit  participants  who  are  reasonably well  controlled  on their 
334 
baseline insulin regimens. We will exclude participants on non-insulin glucose-lowering 
335 
agents, as these can affect glycemic variability themselves and confound the results. We 
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are   not   excluding   patients   with   known   severe   hypoglycemia   or   hypoglycemia 
337 
unawareness in this study, as these are the patients who stand to benefit the most from the 
338 
transition from insulin glargine to IDeg. We are excluding patients with stage 4 or 5 CKD. 
339 
We will be excluding patients with a myocardial infarction in the last 6 months. These 
340 
patients will be excluded as they carry a higher risk that hypoglycemia or hyperglycemia 
341 
may result in mortality. 
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3.10 Visit Procedures 
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Subjects will be screened for study eligibility and interest in participating in this study 
345 
(Screening Visit/Visit 1).  All subjects will have the study explained to them and sign the 
346 
informed  consent  prior  to  beginning  any  study  procedures.  Subjects  must  meet  the 
347 
inclusion criteria and have no exclusions. 
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Randomization and treatment will be initiated only once eligibility is confirmed. 
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There will be 4 phases to the study: 
352 
• A screening phase to establish eligibility that spans from screening visit till 
353 
insertion of study CGM (up to 2 weeks). 
354 
• A baseline observation phase to collect CGM data on their original insulin 
355 
glargine regimen, starting from insertion of study CGM to first dose of IDeg 
356 
administration (~3 days) 
357 
• A treatment phase starting from 1st to last dose of IDeg and consisting of at least 
358 
3 days of IDeg therapy (3-7 days). 
359 
• A follow-up phase from removal of study CGM to exiting from the study (till up 
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to 7 days after the last dose of IDeg) 


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ed on day 3 (see section 3.10.4) 
 
3.10.1 Screening Visit (Visit 1): 
Participants will be seen at the research wing of the Diabetes Care Center (DCC) at the 
University of Washington, Seattle, WA. Research staff will obtain informed consent after 
explaining study procedures. A detailed diabetes and medical history will be collected from 
the subjects. Their current medication regimen will be verified from them, particularly the 
actual number of units of the different insulins they are using. Subjects will undergo 
assessment of vital signs (pulse, blood pressure, weight, height, BMI) and a focused 
physical exam. If there is no available record of eGFR within the last year and/or 
hemoglobin A1c within the last 90 days, these will be obtained by phlebotomy at this visit. 
2 tubes of blood (1x 3cc lavender and 1x 4 cc lime green) will be drawn and sent off to 
measure hemoglobin A1c (by HPLC method) and basic metabolic panel to the UWMC 
clinical laboratory, if required. Subjects will be instructed to not alter their diet, alcohol 
consumption or exercise regimen from the time of study CGM insertion till 48 hours after 
the first dose of IDeg. 
 
If they are considered to be eligible for the study, then the research staff will contact IDS. 
IDS will then randomize the participant to one of the two arms within the two stratified 
groups. (Refer to sections 3.5 and 8.5 for details). Research staff will then contact the 
participant by phone or email to have them return for visit 2 for insertion of the study CGM. 
 
Important considerations for keeping things as uniform as possible in the study are as 
below: 
• We will ensure that all subjects on once daily insulin glargine are taking it at 
bedtime. Subjects who were taking it in the morning only at screening visit, will be 
switched to bedtime dosing at least 7 days prior to study CGM insertion. 
• We will ensure that subjects on twice daily insulin glargine at screening visit are 
taking their 2nd dose of the day at bedtime. 


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395 395 
 
396 
3.10.2 CGM insertion visit (Visit 2): 
397 
Participant will return to the DCC, within 2 weeks of visit 1, to meet with a research 
398 
coordinator who will assist with the insertion of the CGM (Dexcom G6). At this visit, 
399 
study staff  will  also  perform  any teaching  and  training  that  may be  required  for  the 
400 
participant to know how to use the CGM device. This visit needs to be conducted before 
401 
1200  hours.  They  will  be  given  CGM  supplies  to  last  up  to  1  week.  They  will be 
402 
instructed to keep the study CGM on at all times for this duration. If they have their own 
403 
CGM, then they will be allowed to keep that on in addition to the study CGM, should 
404 
they desire to do so. They will be instructed to replace the sensor, if needed. The study 
405 
CGM insertion day will be considered day 0. The next day will be day 1. Transition to 
406 
IDeg will be done on Day 3 as below. Subjects will be dispensed a log book in which 
407 
they will need to document carbohydrates consumed, exercise duration and time, timing 
408 
and doses of basal and bolus insulin (broken down as prandial and correction), self- 
409 
monitored blood glucose values, hypoglycemia symptoms and intervention for each day 
410 
they are in the study (from CGM insertion to removal) (See Appendix A and B). We  will 
411 
inquire about any change to concomitant medications and document insulin doses being 
412 
administered. 
413 
414 
415 
3.10.2.1 Insulin Dosing: 
416 
At visit 2, subjects will also be given written instructions on how to do the transition from 
417 
insulin glargine to IDeg. 
418 
419 
Calculation of IDeg dose 
420 
The dose of IDeg that subjects will be switched to will equal 80% of the total daily dose 
421 
of insulin glargine they reported using at visit 1. This reduction is what was done in the 
422 
clinical  trials  of  conversion  from  any  basal  insulin  to  IDeg  with  lower  risk  of 
423 
hypoglycemia (4). For example, if a subject was on 25 units of glargine at screening visit, 
424 
then they will need to switch to 20 units of IDeg (0.8 X 25 = 20). Number of units will be 
425 
rounded up to the next whole number if decimal points are ≥ 0.5 and rounded down if 
426 
<0.5. 
427 
428 
Timing of IDeg dose 
429 
To keep things consistent across participants, we will instruct all patients to start their 
430 
first dose of IDeg 3 days after the study CGM is inserted. The rationale for this is that the 
431 
first 24 hours of data on the CGM is not very accurate and after that we want 48 hours of 
432 
baseline glucose data on insulin glargine, prior to transitioning to IDeg. This will be used 
433 
later  as  their  baseline  to  compare  with  the  values  seen  on  IDeg.  Subjects  will  be 
434 
instructed  to  administer  their  first  dose  of  IDeg  at  2100  hours  on  the  3rd   day after 
435 
insertion of study CGM. They will then administer the same dose of IDeg every night for 
436 
5 ± 2 consecutive doses. 
437 
438 
Dosing of Insulin Glargine 
439 
Dosing of insulin glargine will depend on the group a subject is randomized to: 


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440 
441 
If randomized to bridging dose: 
442 
For  subjects  on  once-daily glargine,  up  to  day 2  after  study CGM  insertion they will 
443 
administer their usual insulin glargine dose at bedtime. On day 3, they will administer 
444 
50% of their usual glargine dose (using study drug) at 2100 hours along with only their 
445 
FIRST IDeg dose, as calculated. Thereafter, they will not administer insulin glargine till 
446 
after the 5 (± 2) days of IDeg are completed. 
447 
448 
For  subjects  on  twice-daily  glargine,  on  day  3  after  study  CGM  insertion  they will 
449 
administer their AM glargine dose as usual (i.e. 100%). On the same night, they will 
450 
administer 50%  of their bedtime glargine dose  (using study drug) at 2100 hours along 
451 
with  only  their  FIRST  IDeg  dose  as  calculated  above.  Thereafter,  they  will  not 
452 
administer insulin glargine till after the 5 (± 2) days of IDeg are completed. 
453 
454 
If randomized to direct conversion: 
455 
For  subjects  on  once-daily glargine,  up  to  day 2  after  study CGM  insertion they will 
456 
administer their usual insulin glargine dose at bedtime. On day 3, they will administer the 
457 
first dose of IDeg, as calculated above, at 2100 hours and a placebo solution in a dose 
458 
equivalent to 50% of their usual glargine dose. They will NOT  administer  any  insulin 
459 
glargine from that night till after 5 (± 2) days of IDeg are completed. 
460 
461 
For  subjects  on  twice-daily  glargine,  on  day  3  after  study  CGM  insertion  they will 
462 
administer their AM glargine dose as usual (i.e. 100%). On the same night, they will 
463 
administer the first dose of IDeg, as calculated above, at 2100 hours and a placebo 
464 
solution in a dose equivalent to 50% of their bedtime glargine dose. They will NOT 
465 
administer any insulin glargine from that night till after 5 (±  2) days of IDeg are 
466 
completed. 
467 
468 
Use of short-acting insulin 
469 
At the CGM insertion visit (visit 2), subjects will be instructed to use their prandial 
470 
insulin to carbohydrate ratios or pre-specified doses of prandial insulin the way they 
471 
would have otherwise, during the study. For the 48 hours before and after the first dose 
472 
of IDeg, however, all subjects will be instructed not to use any correctional insulin unless 
473 
their blood glucose is >250, both around meals and otherwise. While we understand that 
474 
subjects might be reluctant to allow their blood glucose to run in the 180-250 range 
475 
without correction, we feel this is a necessary part of our study protocol. The main reason 
476 
for this is that our primary study end point is time in range (TIR). If the change from 
477 
insulin  glargine  to  IDeg  results  in  more  time  in  the  180-250  range  in  patients  not 
478 
receiving the bridging dose of glargine, patients are likely to correct this aggressively 
479 
with the use of correctional insulin. This would dilute any measurable differences in our 
480 
primary end point (TIR). It would only potentially show differences in the  secondary end 
481 
points of dose and number of correctional insulin used. However, by telling them to avoid 
482 
bolusing till glucose rises above 250,  we  will be  able to discern  any differences in  TIR 
483 
that might arise from the change of basal insulin, while at the same time, not being unsafe 
484 
for the patients over a 96 hour period of time. 
485 


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486 
3.10.3 Telephone Encounters #1: 
487 
This will be on day 1 (i.e. the day after the study CGM is inserted). We will ensure that 
488 
the study CGM is working and the subject does not have any questions or concerns. 
489 
Study staff will also assist the subject with any troubleshooting, if necessary. Subjects 
490 
will be instructed to upload their CGM data on day 3, for research staff to review it. 
491 
Subjects  will  be instructed  not  to  alter their insulin  glargine dose for the  following 48 
492 
hours, till the night of day 3, when they transition to IDeg. We will inquire about any 
493 
adverse events and change to concomitant medications and document doses of insulin 
494 
being administered by patient. 
495 
 
496 
3.10.4 Telephone Encounter #2: 
497 
Research staff will review patient’s CGM data upload on day 3. We will inquire about 
498 
adverse  events,  any  change  to  concomitant  medications  and  also  document  doses of 
499 
insulin being administered. 
500 
If there is ≥ 38 hours of usable CGM data, then they will be instructed to proceed with 
501 
their first dose of  IDeg that night,  as scheduled.  In  order to obtain the bridging dose  of 
502 
insulin glargine or matched placebo, subjects will be instructed to proceed to IDS at the 
503 
University of Washington to collect their study drug the same day. 
504 
If there is < 38 hours of usable CGM data, then subjects will be instructed to wear their 
505 
CGM, per study protocol, while remaining on their original insulin regimen, and to again 
506 
upload CGM data on day 5. Research staff will review this data on day 5. 
507 
If there is ≥ 38 hours of usable CGM data from day 3-5, they will be instructed to proceed 
508 
with their first dose of IDeg that night, as scheduled. Subjects with < 38 hours of usable 
509 
CGM data will be discontinued from the study. 
510 
 
511 
3.10.5 Telephone Encounter #3: 
512 
This will be on day 4, i.e. the day after the first bedtime dose of IDeg (or on day 6 for 
513 
subjects  who  needed  to  repeat  baseline CGM  data collection).  We will  inquire about 
514 
adverse   events  and   any  change  to   concomitant  medications.  The   doses  of insulin 
515 
administered will be obtained and documented. The main purpose of this call is to ensure 
516 
that the subject implemented the transition from insulin glargine to IDeg, correctly. If it is 
517 
discovered that the subject forgot to transition, then they will be given repeat  instructions 
518 
to  dose on  night  of day 4.  If  it  is  discovered  that  the subject  executed  the transition 
519 
incorrectly, then they will need to undergo a 3-day “wash out period”, during which they 
520 
will resume their original insulin glargine regimen (with alterations as deemed necessary 
521 
by study physician on day 4), and then they will be instructed to execute the transition 
522 
again on night of day 7. If a subject performs the transition erroneously a second time, 
523 
he/she will be discontinued from the study and replaced by a new subject as the study 
524 
supplies allow. Subjects will be instructed not to alter their dose of IDeg for at least the 
525 
first 3 doses (i.e. 48 hours after 1st dose). 
526 


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527 
3.10.6 CGM Removal and Download Visit (Visit 3): 
528 
Subjects will come in approximately 8 ±  2 days after their CGM insertion. At this visit, 
529 
their study CGM will be removed and downloaded. We will inquire about adverse events 
530 
and  any  change  to  concomitant  medications.  We  will  collect  and  review  their study 
531 
logbook.  They  will  also  be  given  instructions  on  how  to  transition  back  to  insulin 
532 
glargine. 
533 
534 
Once-daily  glargine  users:  Approximately  24  hours  after  their  last  dose  of  IDeg, 
535 
subjects will be instructed to administer 50% of their original total daily dose of glargine 
536 
at bedtime. At 48 hours after their last dose of IDeg, they will return to their original 
537 
bedtime insulin glargine dose. 
538 
539 
Twice-daily  glargine  users: Approximately 24 hours after their last dose  of  IDeg, they 
540 
will administer 50% of their original bedtime insulin glargine dose. Approximately 36 
541 
hours  after  their  last  dose  of  IDeg  they  will  again  administer  50%  of  their original 
542 
morning insulin glargine dose. Approximately 48 hours after their last dose of IDeg, they 
543 
will resume their original insulin glargine dosing regimen (i.e. 50% of total dose twice 
544 
daily). 
545 
546 
Subjects will receive a gift card for $50 for participation in the study. 
547 
 
548 
3.10.7 Exit Visit/Telephone encounter #4 (Visit 4): 
549 
This  visit  will  be  approximately 7  days  after  the  study  CGM  removal  (+/-  2 days). 
550 
Subjects  will  be  called  to  see  if  they have  any  concerns  or  questions.  They  will be 
551 
instructed  to  follow  up  with  their  original  endocrinologist  for  any  further  insulin 
552 
adjustments. 
553 
 
554 
3.11 Assessments for Efficacy 
555 
On the screening visit (visit 1), if there is no available record of eGFR within the last year 
556 
and/or hemoglobin A1c within the last 3 months, these will be obtained by venipuncture 
557 
at this visit. The research team nurse or physician will perform this. 2 tubes of blood (1x 
558 
3cc lavender and 1x 4 cc lime green) will be drawn and sent off to measure hemoglobin 
559 
A1c (by HPLC method) and basic metabolic panel to the UWMC clinical laboratory. No 
560 
extra blood will be collected from the subjects. There will be no other instances of blood 
561 
collection during the study. These will help ensure that appropriate subjects are enrolled 
562 
in the study. 
563 
At the various telephone encounters, study staff will verify that the subjects are following 
564 
study instructions correctly. Specifically, on Telephone Encounter #2, only if adequate 
565 
usable CGM data is available on the data uploaded by the patient will they be allowed to 
566 
proceed with the transition (see section 3.11.4). 
567 
By measuring the time a patient spends in range (TIR = 70-180 mg/dL), we are assessing 
568 
the efficacy of the use of IDeg as a basal insulin. 
569 
570 


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571 
3.12 Assessments for Safety 
572 
The  primary safety concern  in  this  study is  the  risk  of  hypoglycemia. Hypoglycemia 
573 
management will be revised at screening visit to ensure appropriate education and all 
574 
medications and supplies needed to manage hypoglycemia will be prescribed at screening. 
575 
Subjects will be instructed that if they see BG <70 mg/dL on their personal CGM that 
576 
persists  longer  than  15  minutes  or  notice  symptoms  of  hypoglycemia  regardless  of 
577 
glucose reading, they need to perform a capillary blood glucose (CBG) measurement to 
578 
confirm if the meter shows a reading <70 mg/dL. If it does, they need to complete a 
579 
hypoglycemia  episode  form  (Appendix  B).  Upon  onset  of  a  hypoglycemic  episode, 
580 
subject is recommended to check CBG every 15 minutes until the value is ≥ 70 mg/dL 
581 
and/or  symptoms   have   resolved.   Repeated  CBG  measurements   and/or   symptoms, 
582 
occurring within a period of 60 minutes after onset on a hypoglycemic episode, will by 
583 
default be considered as one hypoglycemic episode until a succeeding CBG value is ≥ 70 
584 
mg/dL and/or symptoms have been resolved and should be reported as one hypoglycemic 
585 
episode.  CBG  measurements  <  70  mg/dL  or  hypoglycemic  symptoms  after  the  60 
586 
minutes period shall trigger the reporting of a new hypoglycemia episode and prompt  the 
587 
subject to fill out a new hypoglycemic episode form until a succeeding measurement is ≥ 
588 
70  mg/dL and/or  symptoms  have  been  resolved.  In  case  of  several  low  CBG values 
589 
within the 60 minutes interval, the lowest value is the one that will be reported as the 
590 
CBG value for the hypoglycemic episode but the start time of the episode will remain as 
591 
the  time  for  the  first  CBG  value  and/or  symptom.  Whenever  a  subject  completes a 
592 
hypoglycemia episode form, they should notify study staff within 24 hours. When they 
593 
notify study staff, details of the events around the low blood glucose (activity, food intake, 
594 
insulin administration) will be collected from them and then recommendations will be 
595 
made, as deemed necessary, by the study physician. 
596 
Hyperglycemia is the other risk of this study. Subjects will be instructed at screening to 
597 
notify  study  staff  within  24  hours  of  a  blood  glucose  >250.  Study  staff  will  try to 
598 
ascertain  from  the  subject  if  any  investigations  are  needed  and  make  management 
599 
recommendations, as deemed necessary, by the study physician. 
600 
By measuring the time a patient spends above or below range (>180  mg/dL or <70     601  
mg/dL) and assessing the frequency of use of correctional doses of short-acting insulin,   602 we 
are assessing how safe their glycemic management regimen is. 
603 
 
604 3.13 Patient Compliance 
605 Patient compliance to study procedures will be assessed during the telephone encounters. 606      
Compliance will be defined by the following (all 3 need to be met to be considered      607 
compliant), assessed during the 48 hours prior to and after the first dose of IDeg: 
 
608 
• 
No missed doses of basal insulin 
609 
• 
No missed doses of nutritional insulin with meals 
610 
• 
Wearing the study CGM for >19 hours a day 
611 
612 


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613 4. STATISTICAL CONSIDERATIONS: 
614   The primary objective of this pilot study is to calculate the change in percent time that    615    
BG is “in range” (TIR defined as 70-180 mg/dL) in the 48 hours before the first IDeg    616 dose 
vs. the 48 hours after the first dose, and to compare the mean of this change between 617 patients 
who are randomized to receive bridging glargine and those who are randomized  618 to not  receive 
bridging glargine.  Randomization will  be stratified by glargine use (once 619   vs. twice daily). 
For each patient, the TIR  in the 48 hours before first IDeg use will be   620   calculated,  as will 
the TIR in the 48 hours after first  IDeg use. The difference of these   621    values will then be 
calculated, and the mean of the differences compared between the    622 randomized arms.  Our  
primary  hypothesis  will  assume  that  the  “bridging  effect”  is 623 similar between patients who 
take glargine once daily and twice daily. However, we plan 624 an exploratory look at this 
assumption as a secondary objective. 
625 
626 If we assume the true change in TIR (before first  dose of  IDeg minus  after first dose of  627 
IDeg)  to be 0% for the  bridging group and  15%  for the  non-bridging group, and if  we 628 
assume a common standard deviation of 15% (meaning the distributions of change in TIR 629   are 
separated by 1 standard-deviation unit), then 20 patients in each group will provide   630 87% 
power to observe a statistically significant (at the two-sided level of .05) difference  631 in mean 
change of TIR. 
632 
633  As noted above, we’ll assess the magnitude of this difference as a function of once- vs.   634  
twice-daily glargine use.  With only 40 patients,  it’s highly unlikely that  a statistically   635    
significant interaction will be observed, but if the directions of the difference in mean    636     
changes  are the same in the once-daily vs. twice-daily groups we shall consider the      637 results 
to be consistent with each other. 
638 
639 
Secondary endpoints to be assessed in a descriptive manner include the following: 
640 
 
1. Coefficient of variation of TIR for each treatment within each group 
641 
2. Nocturnal time in range of 70-180 mg/dL (nTIR; both values included) (between 
642 
 
mid-night and 0600 hours) 
643 
3. Percent time above 180 mg/dL (TAR-1), percent time above 250 mg/dL (TAR-2) 
644 
 
for each treatment within each group 
645 
4. Percent time below 70 mg/dL (TBR-1), percent time below 54 mg/dL (TBR-2)  
646 
 
for each treatment within each group 
647 
5. Number of correction boluses for each treatment within each group 
648 
649     The overarching goal of  this pilot study is to collect data in a controlled setting on a     650  
variety of long-acting insulin regimens  and  gain  an idea if there is  a signal.  The data   651     
generated in this pilot study will be used to assist in the design of a future and larger     652 study 
where a more definitive comparison of efficacy will be conducted. 
653 
654 
655 
5.  DATA HANDLING AND RECORD KEEPING: 
656 
Study  information  will  be  collected  for  each  participant  by  research  staff  using  
657 
standardized Case xReport Forms (CRFs). CRFs will not report information about 


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658 treatment assignment in order to maintain blinding of treatment allocation. Forms will be 659 
stored at a secure location at the clinical site.  We expect that the majority of data will be  660 
collected via CRFs; however, other data sources, such as CGM download and laboratory  661  data,  
may be used.  All  study data will  be  entered  into  the Research  Electronic Data  662 Capture 
(REDCap),  a  web-based  data  entry  and  management  system  that  is  HIPPA 663   compliant 
and powered  by the  Institute of Translational Health Sciences, by research    664 staff.  The 
clinical data management procedures will be consistent with the International  665 Conference on 
Harmonisation (ICH E6) standards for Good Clinical Practice (GCPs)1. 
666 
667 
668 
6.  ETHICS: 
669 Ethical  considerations  related  to  the trial  include ensuring that  all  patients  receive an 670    
amount of insulin deemed appropriate by the clinicians for treatment of their diabetes    671 
mellitus both during the study period and following the conclusion of the study. Patients  672    
should have prompt treatment for both hypoglycaemia and hyperglycemia with blood    673 
glucose level of > 250mg/dl, as well as other possible complications related to treatment  674 with 
insulin, according to the standard of care following the guidance of their clinicians.  675  Potential 
participants will be sought from among the patients attending the study center,  676 University of 
Washington’s Diabetes Care Center in Seattle, WA.  An application will be 677 submitted for  
approval  by  University  of  Washington's  IRB  prior  to  conducting  the  678   research study.   
Potential candidates  will be identified and contacted according to the   679 procedures established 
by University of Washington’s IRB in compliance with local laws 680 protecting patient 
confidentiality and in accordance with the Declaration of Helsinki and  681  the  ICH GCP  
guidelines1.  Patients meeting the  inclusion and exclusion criteria of the   682   study will be 
identified by clinicians at the study center and offered the opportunity to    683  participate in the 
study.  An informed consent form will be given to all patients meeting  684   the inclusion and 
exclusion criteria.   This informed consent form will clearly offer the   685    possibility to opt out 
of any further contacts  with the study.  Written consent will be     686    obtained from all subjects 
invited to participate in the study after explaining again the    687  purpose  and  procedures  of  
the  study.  In  the  initial  contact  and  at  the  time  of  the 688 screening visit,  study subjects  
will  be encouraged  to  ask  questions  and  they will  be  689 reassured that they may withdraw 
from the study at any time.  Clinician investigators and 690  Novo Nordisk, will comply with all 
applicable  regulatory and legal requirements,  ICH  691 GCP guidelines  and  the  Declaration  of  
Helsinki  in  obtaining  and  documenting  the  692 informed consent1. 
693 
694 
695 
7.  STUDY SCHEDULE: 
696 The study  will  begin  recruitment  of  patients  immediately  following  the  approval  of 697  
University of Washington’s  IRB.  We plan to  recruit patients over  a 12-month period.  698  
Following the completion of patient recruitment and data collection, we plan to perform  699 data 
analysis and complete the integrated final study report over a 4-month period. 
700 


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701 
7.1 
Study Schedule 
 
Event 
Screening 
Visit 
Observation 
on Glargine 
Treatment 
with 
IDeg 
Follow- 
Up 
Up to 
2 weeks 
Day 0 
Day 1 
Day 3 
Day 4a 
Day  
7 ± 2a 
Day 
14 ± 2a 
Informed consent/ 
HIPPA 
x 
History/focused exam 
x 
Weight and vital signs 
x 
Documentation of insulin 
doses 
x 
x 
x 
x 
x 
x 
Documentation 
of 
concurrent medications 
x 
x 
x 
x 
x 
x 
Inquiry of adverse events 
x 
x 
x 
x 
x 
x 
Download of data from 
home glucose meter 
and/or CGMb 
x 
Labs 
x 
Eligibility 
x 
Randomization 
xc 
Study Drug Dispensation 
x 
Placement of study CGM 
x 
Daily Insulin logbook 
and hypoglycemia 
episode form 
dispensation 
x 
Telephone Encounter 
x 
x 
x 
x 
Collection of data from 
study CGM Upload 
x 
Study Drug 
Administration 
x 
x 
x 
Study 
Logbook/Hypoglycemia 
form Collection 
x 
Download 
data 
from 
study CGM 
xd 
702 
a.   Day 4, 7, and 14 may be extended by 2 days if patients do not have ≥ 38 hours of   
703 
 
usable study CGM data. See Section 3.11.4. 
704 
b. Download of data from patients’ CGM will be performed if patients wear their own 
705 
 
CGM prior to participating in the study. 


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706 
c. Randomization will be performed at  the  end  of  the  screening visit  after  patients 
707 
 
complete informed consent and have been deemed eligible to participate in the study. 
708 
d. Downloaded data include all endpoints listed under Section 3.2. 
709 
 
710 
 
 
 
 
711 
712 
713 
7.2 
Study Milestones 
Phase 1: 
IRB Approval 
Months 1-3 
 
 
Phase 2: 
Study 
Recruitment 
Months 4-15 
 
 
Phase 3: 
Data Analysis 
Months 16-19 
 
 
Phase 4: 
Publication 
Months 19+ 
714 
8.  STUDY DRUGS AND MATERIALS: 
715 
8.1 
Study medication(s) / devices(s) 
716 
• Insulin glargine, 100 units per mL injected subcutaneously daily, dosage as 
717 
determined by the clinician and study protocol. Manufacturer: Sanofi or Lilly 
718 
• IDeg, 100 units per mL injected subcutaneously daily, dosage as determined by 
719 
the clinician and study protocol. Manufacturer: Novo Nordisk. 
720 
• Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily, 
721 
dosage as determined by the clinician and study protocol. 
722 
• Pen needles for injecting insulins. 
723 
• Dexcom G6 Mobile CGM System, inserted subcutaneously and worn for 3-10 
724 
days. Manufacturer: Dexcom, Inc. 
725 
• Glucose meter and 100 test strips, to perform self-monitoring of blood glucose, 
726 
one box dispensed per patient. Source: Diabetes Care Center. Manufacturer: 
727 
Accucheck Aviva Plus 
728 
 
729 8.2 Packaging and Labelling of Study Medication(s) 
730 
• IDS will package the  glargine  and  placebo  as  pre-filled  syringed  from  vials 731
 
 
identically. IDS will then label the syringes with dose, dosing instructions, and 2 
732 
 
patient identifiers based on study drug request order entered by research staff,  733
 
 
after being notified about treatment assignment by IDS. 
734 
• IDeg will be dispensed in the original manufacturer’s packaging,  and  IDS will  735
 
 
label IDeg with dose, dosing instructions, and 2 patient identifiers. 
736 
•   Dexcom G6 Mobile CGM System will be distributed to patients in its original   737
 
 
manufacturer packaging. 
738 
739 
Labelling of all medications and device will be in accordance with local law and study 
740 
requirements. 
741 


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742 8.3 Storage and Drug Accountability of Study Medication(s) 
743 All investigational  and/or  trial  products  received  will  be  accounted  for  by  the  IDS. 744     
Accountability logs are maintained for each product and dispensing is logged out as     745   
individual line items. Other than syringes and needles, subjects will return used, partly   746  used, 
and unused products, and these will be documented on the accountability logs and  747 may be 
retained for reconciliation. 
748 
749 All products will  be  stored  at  the  designated  temperature  (e.g.  refrigerated  or  room 750 
temperature) with temperature monitoring by the institutional system, TempTrak. This is 751 a 
continuous monitoring system  with  temperature time points  taken  every 15  minutes. 752 
Temperature  graphs  are  accessible  via  a  web-based  system.  TempTrak  sensors  are  753  
calibrated on a yearly basis. A second overlay is the use of Min/Max thermometers with  754  
manual recording of temperature daily on Mon - Fri. All Min/Max thermometers have a  755 
calibration certificate and are replaced prior to the expiration date. 
756 
757 Destruction of trial products are by incineration at an EPA approved site as contracted by 758 
the University of Washington Medical Center, currently by Clean Harbors Environmental 759   
Services.  If  preferred,  trial  products  can  be  shipped  back  to  the   Novo  Nordisk.   760 
Destruction of returns  can be performed  on an on-going basis. At study closure, all trial  761 
products  are  accounted  for and  any unused  remaining inventory can  be destroyed  or  762 
shipped back to Novo Nordisk. 
763 
764 At the time of study drug prescription and dispensing, research staff will provide patients 765  
with instructions to store the study drug at room temperature (below 86oF), keeping the   766  study 
drug away from direct heat and light.  Research staff will verify the conditions for  767  storage 
with patients on day 7±2 of study intervention period.   However, research staff   768  will not 
specifically require patients to measure or record the storage temperature of the  769 study drug 
because  of  the  short  duration  of  the  study intervention  period,  making  it 770 extremely 
unlikely for the  study drug to  be  compromised  as  long as  patients  properly 771    follow the 
storage instructions.   There will be no trial medication(s) dispensed to any    772 person not 
enrolled in the study.  IDS  will store unused study drug separately from used  773  study drugs in 
the refrigerator  at 36°F to 46°F (2°C  to 8°C) until the drug’s  expiration  774    date.   Patients 
will be instructed to return used/unused study drug, and  University of    775 Washington’s IDS 
will destroy the returned study drug per its standard protocol outlined  776 above. 
777 
 
778 8.4 Auxiliary Supply 
779  There is  no additional  item  or equipment  needed other than the ones  listed under the   780  
section of Study medication(s) / devices(s).  Patients may continue to use the following   781 
medications and devices during the study period: 
782 
•  A  rapid-acting  insulin  analogue  that  patients  normally  take  following  the   783
 
 
instructions of their clinicians, administered using either insulin pens or vials and 
784 
 
syringes 
785 
• Glucagon emergency kit, inject 1  mg/mL subcutaneously or  intramuscularly as 786
 
 
needed for treatment of severe hypoglycemia 


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787 
• Home glucose meters 
788 
• Home continuous glucose monitors 
789 
 
790 8.5 Randomization and Blinding 
791  We will perform a randomized, placebo-controlled intervention study to  minimise bias.  792 
Study participants will be randomized in a 1:1 ratio to one of two arms within 2 stratified 793  
groups groups (see Section 3.3).  After a participant has been randomized, a study drug   794   
request will be  sent to  IDS  to dispense the  study drug.   In  keeping with the blinded   795  
procedure, the patient and research staff will not be aware of treatment assignment. The  796  study 
drug request sent to  IDS will reflect only the dose of bridging insulin they should  797 receive. 
IDS  with then dispense a prefilled syringe of either insulin  glargine or matched 798  placebo to 
reflect this dose, directly to the research participant on  the day it needs to be  799   administered. 
Participants will then administer the study drug at home according to the   800  instructions  
provided  to  them  by  their  clinician  investigators  and/or  research  staff  801  according  to  
their  randomized  assignment  and  the  dosing  described  under  Section  802 3.11.2.1. 
803 
 
804 8.6 Breaking of Blinded Codes 
805    Breaking of the blinded code will not be applicable, as medical emergencies that may    806  
possibly associated with treatment with insulin will be no different between the control   807 and 
the study groups.  However, breaking the blinded code may be done if demanded by  808   the 
patient.   Whenever a code is broken, the person breaking the code must record the   809 time, date 
and reason, as well as his/her initials in the source documents.  All codes must  810   be kept 
throughout the study period.   Accountability of  all broken or unbroken codes    811 (hard copy 
or electronic) will be performed at or after trial closure. 
812 
813 
814 
9.  CONCOMITANT ILLNESSES AND MEDICATIONS: 
815 9.1 Definitions: 
816 Concomitant illness: any illness that is present at the start of the trial (i.e. at the first visit). 817 
Concomitant medication:  any medication  other  than  the  trial  product(s)  that  is  taken 818 
during the trial, including the screening and run-in periods. 
819 Details of all concomitant illnesses and medication must be recorded at trial entry (i.e. at  820 
the first visit). Any changes in concomitant medication must be recorded at each visit. If  821 the 
change influences the subject’s eligibility to continue in the trial, Novo Nordisk must 822 be 
informed. 
823 The information collected for each concomitant medication includes, at a minimum, start 824 
date, stop date or continuing, and indication. 
825 For  each  concomitant  illness,  date  of  onset,  date  of  resolution  or  continuing,  at  a  826 
minimum, should be recorded. 
827 
828 


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829 
 
830 
831 
832 
 
833 
834 
835 
836 
837 
838 
839 
840 
841 
842 
843 
844 
845 
846 
847 
848 
849 
850 
851 
852 
853 
854 
855 
856 
857 
858 
859 
860 
861 
862 
863 
864 
865 
866 
867 
868 
869 
870 
871 
872 
10.  ADVERSE EVENTS: 
10.1 Definitions 
The FDA approved version of the Prescribing Information or update thereof will be used 
for assessment of expectedness. 
 
10.1.1 Adverse Event (AE): 
An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or 
not related to the trial product(s). This includes events reported from the first trial related 
activity after the subject has signed the informed consent and until post treatment follow-
up period as defined in the protocol. The following should not be recorded as AEs, if 
recorded as medical history/concomitant illness on the CRF at screening: 
• Pre-planned procedure, unless the condition for which the procedure was planned has 
worsened from the first trial related activity after the subject has signed the informed 
consent 
• Pre-existing conditions found as a result of screening procedures 
 
Clinical Laboratory Adverse Event: 
A clinical laboratory AE is any clinical laboratory abnormality regarded as clinically 
significant i.e. an abnormality that suggests a disease and/or organ toxicity and is of a 
severity, which requires active management, (i.e. change of dose, discontinuation of trial 
product, more frequent follow-up or diagnostic investigation). 
 
Serious Adverse Event (SAE): 
A serious AE is an experience that at any dose results in any of the following: 
• Death 
• A life-threatening* experience 
• In-patient hospitalisation or prolongation of existing hospitalization 
• A persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
• Important medical events that may not result in death, be life-threatening*, or require 
hospitalisation may be considered an SAE when, based upon appropriate medical 
judgement, they may jeopardise the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition 
• Suspicion of transmission of infectious agents 
*The term life-threatening in the definition of SAE refers to an event in which the subject was at risk of death 
at the time of the event. It does not refer to an event which hypothetically might have caused death if it was 
more severe. 
 
Serious Adverse Drug Reaction (SADR): 
An adverse drug reaction (ADR) is an adverse event (AE) for which a causal relationship 
to the trial product is at least possible i.e. causal relationship is conceivable and cannot be 
dismissed. Serious adverse reaction (SAR): Adverse event which fulfils both the criteria 
for a Serious Adverse Event and the criteria for an Adverse Reaction. 
 
Suspected Unexpected Serious Adverse Reaction (SUSAR): 


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873 
An SAE which is unexpected and  regarded  as  possibly  or  probably  related  to  the  
874 
trial/study product by the investigator. 
875 
876  Medical  Events  of  Special  Interest  (MESI): A MESI is (1) a medication error (e.g.  877  
wrong  drug  administration   or  wrong  route  of   administration)  or  (2)  a  suspected   878 
transmission of an infectious agent via the product 
879 
880 
Non-Serious Adverse Event: 
881 
A non-serious AE is any AE which does not fulfil the definition of an SAE. 
882 
 
883 
10.2 Severity Assessment Definitions: 
884 
• Mild: Transient symptoms, no interference with the subject’s daily activities 
885 
• Moderate: Marked symptoms, moderate interference with the subject’s daily activities 
886 
• Severe: Considerable interference with the subject’s daily activities, unacceptable 
887 
 
888 
10.3 Relationship to study medication Assessment Definitions: 
889 
• Probable: Good reasons and sufficient documentation to assume a causal relationship 
890 
• Possible: A causal relationship is conceivable and cannot be dismissed 
891 
• Unlikely: The event is most likely related to an etiology other than the trial product 
892 
 
893 10.4 Outcome Categories and Definitions: 
894 • Recovered:  Fully recovered  or  by  medical  or  surgical  treatment  the  condition  has 895   
returned to the level observed at the first trial related activity after the subject signed the 896 
informed consent 
897 • Recovering: The condition is improving and the subject is expected to recover from the 898 
event. This term should only be used when the subject has completed the trial 
899  • Recovered with sequelae:  As  a result  of the AE, the subject  suffered persistent  and   900   
significant disability/incapacity (e.g. became blind, deaf, paralysed). Any AE recovered 901 with 
sequelae should be rated as an SAE 
902 
• Not recovered 
903 
• Fatal 
904 
• Unknown 
905 
 
906 10.5 Collection, Recording and Reporting of Adverse Events 
907 All events meeting the definition of an adverse event will be collected and reported from  908 
the first study-related activity after the subject has signed the informed consent and until  909 the 
end of the posttreatment follow-up period as stated in the protocol. 
910 
911 
We intend to comply with all local legal, regulatory, and IRB requirements. 
912 
913 
All AEs will be reported on the Adverse Events form that will be completed by the study 
914 
staff, who are masked as to study treatment assignment, at each regular follow-up visits. 


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915  This  will  ensure  that  AEs  are  ascertained  in  an  unbiased  manner  using  the  same  916  
standardized  methodology  for  patients  in  both  treatment  arms.  Forms  will  include  917  
standardized questions relating to specific events of import in diabetic patients on either  918 of 
the  study treatment  arms,  as  well  as  any significantly abnormal  physical  findings  919  
identified on examination and any significantly abnormal laboratory results obtained on  920 the 
patient between visits or at the time of the visit.  AEs reported or ascertained between 921  clinic 
visits will be captured and  reported  at the  time of the  next scheduled visit.  Pre-  922 existing 
conditions (that  is,  any condition  that  was  known  to  be  present  prior to  the 923  signing of 
informed consent or was identified during the screening procedures) will not   924  be considered 
or recorded as AEs unless the condition worsens in intensity or frequency  925  after the initiation 
of study intervention.  Likewise, continuing AEs will not be reported   926 as AEs at subsequent 
visits unless they increase in severity or frequency between  visits,  927   they result in criteria for 
a SAE, and/or they resolve between visits.   The investigators   928  will report all adverse events 
including SAEs, SUSARs, serious adverse drug reactions   929  (SADRs) to the competent 
authority and independent ethics committee/IRB based upon  930  federal regulations and 
local/IRB policies.  The investigators will also  report all SAEs,   931     SUSARs, and SADRs to 
Novo Nordisk at the same time such events are reported to     932  regulatory authorities or within 
15 days from the investigators becoming aware of such   933 adverse events, whichever comes 
first. 
934 
935 
The investigators will collect the following information at minimum for each of these  
936 
events: 
 
937 
1. Study name 
938 
2. Patient identification (e.g. initials, sex, age) 
939 
3. Event (preferably a diagnosis) 
940 
4. Drug 
941 
5. Reporter identification (e.g. Name, or initials) 
942 
Also 6) Causality, and 7) Outcome 
943 
 
944 
10.6 Follow-up of Adverse Events 
945 
During and following a subject’s participation in a clinical trial, the investigators and  
946 
institution will provide adequate medical care to the study subject for any study-related 
947 
adverse events, including clinically significant laboratory values related to  the  study. 
948 
This medical care for study subjects will be provided regardless of their insurance status. 
949 
950 All adverse events classified as serious or severe or possibly/probably related to the trial  951     
product must be followed until the subject has recovered and  all queries have been      952  
resolved.  For  cases  of  chronic  conditions  follow-up  until  the  outcome  category  is  953 
“recovered” is not required, as these cases can be closed with an outcome of “recovering” 954 or 
“not recovered”. 
955 
956 
All other adverse events must be followed until the outcome of the event is “recovering” 
957 
(for chronic conditions), or “recovered” or until the end of the post-treatment follow-up 


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958 
959 
960 
 
961 
962 
963 
964 
965 
966 
967 
968 
969 
970 
971 
972 
 
973 
974 
975 
976 
977 
978 
979 
980 
981 
982 
983 
984 
985 
986 
987 
988 
989 
990 
991 
992 
993 
994 
995 
996 
997 
998 
999 
1000 
1001 
stated in the protocol, whichever comes first, and until all queries related to these AEs have 
been resolved. 
 
10.7 Pregnancy 
Study subjects will be instructed to notify the investigators immediately if they become 
pregnant. 
 
The investigators will report to Novo Nordisk any pregnancy occurring during the trial 
period. Reporting of pregnancy by investigators will occur within the same timelines 
described above for reporting of Adverse Events. 
 
Pregnancy complications should be recorded as adverse event(s). If the infant has a 
congenital anomaly/birth defect this must be reported and followed up as a serious adverse 
event. 
 
10.8 Precautions/Over-dosage 
All patients enrolled in the study will have access to and be instructed to wear a CGM from 
day 0 until the completion of study intervention. Patients may continue to wear the CGM 
as part of the standard of care for their diabetes beyond the study period. Use of a CGM 
has been shown to be effective in preventing hypoglycemia, which is a possible 
complication related to overdose of insulin, as well as morbidities and mortality related to 
hypoglycaemia (11). Clinician investigators and/or research staff will also provide patients 
with instructions on prompt recognition and proper treatment of hypoglycemia and 
prescribe patients with glucagon kit to be used for treatment of hypoglycemia as needed. 
Patients will have access to medical providers at the DCC by phone or e-care 
communication if additional guidance is needed in the event of overdose by the study drug 
during the study. 
 
 
11.  LIABILITY AND SUBJECT INSURANCE: 
During and following a subject’s participation in the clinical trial, the investigators and 
their institution will provide adequate medical care to the study subject for any study- 
related adverse events, including clinically significant laboratory values related to the 
study. This medical care for study subjects will be provided regardless of their insurance 
status. 
 
The investigators will be responsible for the conduct of the study and agree to defend, 
indemnify, and hold harmless Novo Nordisk, any of its parent companies, affiliates, or 
subsidiaries, and their respective officers, directors, employees, agents, representatives, 
distributors, salespersons, customers, licensees, and end-users from and against any claim, 
suit, demand, loss, damage, expense or liability imposed by any third party arising from or 
related to: (a) any breach of Novo Nordisk-investigators’ obligations or representations; or 
(b) Novo Nordisk-investigators’ negligent or grossly negligent use or willful misuse of the 
study drug, the results, or services derived therefrom. This 


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1002 
1003 
1004 
1005 
1006 
1007 
1008 
1009 
1010 
1011 
1012 
1013 
1014 
1015 
1016 
1017 
1018 
1019 
1020 
1021 
1022 
1023 
1024 
1025 
1026 
1027 
1028 
1029 
1030 
1031 
1032 
1033 
1034 
1035 
1036 
1037 
1038 
1039 
1040 
1041 
1042 
1043 
1044 
1045 
1046 
indemnification shall not apply in the event and to the extent that a court of competent 
jurisdiction or a duly appointed arbiter determines that such losses or liability arose as a 
result of Novo Nordisk’s gross negligence, intentional misconduct, or material breach of 
its responsibilities. 
 
 
12.  EVALUABILITY OF SUBJECTS: 
For all analyses, patients not meeting the compliance criteria of the study listed under 
Section 3.13 will not be included in the analyses. Clinician investigators will determine 
patients’ compliance with study drug based on patient’s recorded log and patients’ time 
spent wearing CGM after CGM data has been downloaded at the follow-up visit. We will 
include data from all randomized participants in our data analysis. The subjects or 
observations to be excluded, and the reasons for their exclusion will be documented and 
signed by the clinician investigators or staff prior to database release. The documentation 
will be stored together with the remaining trial documentation. 
 
PK and/or PD Modelling 
PK and PD modelling is not planned for this study. 
 
 
13. PREMATURE TERMINATION OF STUDY: 
All patients participating in the study will have already been taking insulin glargine prior 
to their enrolment in the study. Therefore, we do not anticipate patients developing any 
unforeseen adverse effect associated with the administration of insulin glargine. Similarly, 
we do not anticipate patients developing any unforeseen adverse effect associated with the 
administration of the placebo (normal saline). 
 
IDeg will be discontinued if a patient: 
• Experiences an SAE related to IDeg (with the exception of hypo- or 
hyperglycemia) or an intolerable AE, such as a persistent allergy or rash. 
• Becomes pregnant or breastfeeding 
• Withdraws consent for participation in the study 
 
Date and reason for drug discontinuation will be recorded on the relevant Case Report 
Form. Refer to Section 3.7 for Withdrawal Criteria.  All study discontinuations decided by 
the clinician investigators will be reviewed by University of Washington’s IRB. Patients 
discontinued from the study will be placed back on their original home insulin regimen and 
asked to follow up with their outpatient endocrinologists within 2-12 weeks, or at an 
interval deemed appropriate by their outpatient endocrinologists. Major attempts will be 
made to schedule an end-of-study follow-up phone call for all patients who are lost to 
follow-up during the course of the study. 
 
Patients who discontinue study drug or withdraw consent from the study prior to 
completion of data collection will not be replaced. 


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1047 
1048 
1049 
1050 
1051 
1052 
1053 
1054 
1055 
14.  PUBLICATION PLAN: 
Data and results generated from the study will be published or publicly presented at 
national and/or regional meetings in the form of abstracts, posters, and/or oral 
presentations. Clinician investigators will make good faith effort to publish data and results 
of this study in a peer reviewed scientific journal. The clinician investigators intend to 
register the study with clinicaltrials.gov. 


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1056 
1057 
1058 
1059 
1060 
1061 
1062 
1063 
1064 
1065 
1066 
1067 
1068 
1069 
1070 
1071 
1072 
1073 
1074 
1075 
1076 
1077 
1078 
1079 
1080 
1081 
1082 
1083 
1084 
1085 
1086 
1087 
1088 
1089 
1090 
1091 
1092 
1093 
1094 
1095 
1096 
1097 
1098 
1099 
1100 
1101 
1102 
1103 
1104 
 
15.  REFERENCES: 
1. Heise T, Nosek L, Bottcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec 
has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 
2012; 14:944-950. 
2. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and 
their clinical relevance. Clin Pharmacokinet 2014; 53:787-800. 
3. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin 
degludec: four times lower pharmacodynamic variability than insulin glargine 
under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 2012; 
14:859-864. 
4. Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen 
TSS, Warren M, Group I, Switch. Effect of Insulin Degludec vs Insulin Glargine U100 
on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized 
Clinical Trial. Jama 2017; 318:33-44. 
5. Liu W, Yang X, Huang J. Efficacy and Safety of Insulin Degludec versus Insulin 
Glargine: A Systematic Review and Meta-Analysis of Fifteen Clinical Trials. Int J 
Endocrinol 2018; 2018:8726046. 
6. Hamamoto Y, Honjo S, Fujimoto K, Tokumoto S, Ikeda H, Wada Y, Koshiyama H. 
Basal and Bolus Insulin Dose Changes after Switching Basal Insulin to Insulin Degludec 
in Patients with Type 1 Diabetes Mellitus: A Pilot Study. Clin Drug Investig 2017; 
37:845-852. 
7. Bohn B, Zimmermann A, Wagner C, Merger S, Dunstheimer D, Kopp F, Gollisch K, 
Zindel V, Holl RW, Initiative DPV. Real-life experience of patients starting insulin 
degludec. A multicenter analysis of 1064 subjects from the German/Austrian DPV 
registry. Diabetes Res Clin Pract 2017; 129:52-58. 
8. Lane WS, Weatherall J, Gundgaard J, Pollock RF. Insulin degludec versus insulin 
glargine U100 for patients with type 1 or type 2 diabetes in the US: a budget impact 
analysis with rebate tables. J Med Econ 2018; 21:144-151. 
9. Lecumberri E, Ortega M, Iturregui M, Quesada JA, Vazquez C, Orozco D. Quality-of-life 
and treatment satisfaction in actual clinical practice of patients with Type 1 diabetes 
mellitus (T1DM) and hypoglycemia treated with insulin degludec. Curr Med Res Opin 
2018; 34:1053-1059. 
10. Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, 
Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily 
administration of degludec, a basal insulin with an ultralong duration of action. J 
Diabetes 2016; 8:132-138. 
11. ICH. Guideline for Good Clinical Practice in International Conference on Harmonisation 
of Technical Requirements for Registration of Pharmaceutical for Human Use. 1996. 
12. Wolpert HA. Use of continuous glucose monitoring in the detection and prevention of 
hypoglycemia. J Diabetes Sci Technol 2007; 1:146-150 


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1105 
1106 
1107 
1108 
1109 
1110 
1111 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1112 
1113 
1114 
1115 
1116 
1117 
1118 
1119 
1120 
1121 
1122 
1123 
1124 
1125 
1126 
1127 
1128 
1129 
APPENDIX A: Sample Subject Daily Insulin Logbook, version-1.0 
Trial ID: U1111-1214-3257 
Subject No. XX Subject Initials: ABC Subject DOB: MMDDYY 
Date: MMDDYY  Study Day: # 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* To be used only if needed. NOTE: please use these fields to enter any snacks consumed 
as well. 
 
Did you exercise today? [ ] yes or [ ] no 
If yes, then please specify when and how long: from  
to  
(hh:mm) 
Time 
point 
Time 
(hh:mm) 
BG 
value 
(mg/dL) 
Carbohydrates 
consumed 
(grams) 
Bolus insulin 
dose    
NUTRITIONAL 
(units) 
Bolus insulin 
dose   
CORRECTION 
(units) 
Basal 
insulin 
dose 
(units) 
Before 
breakfast 
Before 
lunch 
Before 
dinner 
At 
bedtime 
*Extra 
time 
point #1 
*Extra 
time 
point #2 
*Extra 
time 
point #3 


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1130 
1131 
1132 
1133 
1134 
1135 
1136 
1137 
1138 
1139 
1140 
1141 
1142 
1143 
1144 
1145 
1146 
1147 
1148 
1149 
1150 
1151 
1152 
1153 
1154 
1155 
1156 
1157 
1158 
1159 
1160 
1161 
1162 
1163 
1164 
1165 
1166 
1167 
1168 
1169 
1170 
1171 
1172 
1173 
1174 
1175 
1176 
 
APPENDIX B: Sample Subject Hypoglycemia Episode Form, version 1.0 
(see Section 3.12 for details on directions to fill out this form) 
 
Trial ID: U1111-1214-3257 
Subject No. XX Subject Initials: ABC Subject DOB: MMDDYY 
Date: MMDDYY  Study Day: # 
1. When did the low BG start?  
(hh:mm) 
2. What was the lowest BG value during the episode?  
(mg/dL) 
3. Did you experience any of the following symptoms with this low BG? 
[ ] No or [ ] Yes (check all that apply) 
[ ] Sweating 
[ ]Trembling 
[ ] Feeling hungry 
[ ] Rapid or irregular heartbeat 
[ ]Feeling confused 
[ ]Feeling drowsy 
[ ]Speech difficulty 
[ ]Visual disturbances 
[ ]Odd behavior 
[ ]Impaired balance 
[ ]Reduced coordination of movements 
[ ]Headache 
[ ]Feeling discomfort or unease 
[ ]Seizure 
[ ]Loss of consciousness 
[ ]Other 
4. Were you able to manage it by yourself? [ ] yes or [ ] no. If no, please fill out Q9- 
12 as well. If yes, please skip Q9-12. 
5. How did you treat the low BG?   
 
6. When did the low BG resolve?  
(hh:mm) 
7. Did this episode happen in relation to physical activity? [ ]Yes or [ ]No 
If yes, then what were you doing?   
 
8. Were you asleep when the low blood glucose happened? [ ]Yes or [ ]No 
9. Who assisted in treatment of the episode?   
 
10. Where was the treatment administered?   
 
11. What treatment was provided to treat the episode?   
 
12. Were your symptoms alleviated by this treatment? [ ]Yes or [ ] No 

ICF_003.pdf: 
Brief Title: Comparison of Glargine to Degludec Insulin Transition With or Without a 
Bridging Glargine Dose ( GLIDING ) 
 
Official Title: A Randomized Comparison of Transitioning From Insulin GLargine to Insulin 
Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in 
Patients With Type 1 Diabetes Mellitus - a Pilot 
StudyNCT number: NCT04623086 
PI Name: Arthi Thirumalai MD 
Document name: consent 
IRB approval date: 08/13/2020 


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UNIVERSITY OF WASHINGTON 
CONSENT FORM 
GLIDING study: A randomized comparison of transitioning from insulin GLargine to Insulin 
Degludec usING a bridging dose of glargine versus direct conversion, in patients with type 1 
diabetes mellitus – a pilot study. 
 
Study Team, UW Medicine Diabetes Institute, Clinical Diabetes Research: 
Arthi Thirumalai, MBBS, Assistant Professor of Medicine 
Jing H. Chao, MD, Clinical Assistant Professor of Medicine 
Irl B. Hirsch, MD, Professor of Medicine 
Dori Khakpour, RD, CD, CDE, Research Manager 
Thanmai Kaleru, Research Assistant 
You can call us at 206-598-4882. The patient care representative will transfer your call. Your 
study team will give you a card with their direct number on it. You can contact Arthi Thirumalai 
by paging 206-314-6080. 
 
24-hour emergency phone number: 
Call 206-598-6190. Ask the operator for the Diabetes Care Center doctor on call. 
 
We are asking you to be in a research study. This form gives you information to help you decide 
whether or not to be in the study. Being in the study is voluntary. Please read this carefully. You may 
ask any questions about the study. Then you can decide whether or not you want to be in the study. 
 
KEY INFORMATION ABOUT THIS STUDY 
Insulin degludec (IDeg) is an ultra-long-acting basal insulin. It is increasingly used to treat 
patients with type 1 diabetes (T1D). Studies of patients switching from long-acting insulins  
(such as glargine) to IDeg have shown several benefits. These include lower rates of 
hypoglycemia (low blood sugar), lower fasting blood sugars and needing less basal insulin. 
 
Patients most often stop their current basal insulin and start IDeg at the same dose at their next 
scheduled time (Routine A). However, this can lead to poor blood sugar control after they 
switch. This is because IDeg reaches a stable level in the body after the previous basal insulin 
has stopped acting. Some doctors have their patients take a one-time, partial dose of their current 
basal insulin when starting their first dose of IDeg (Routine B). The theory is that this “bridging” 
dose will improve blood sugar control during the time the basal insulin is being changed. 
 
In this research study, everyone will switch from insulin glargine to IDeg for 3-4 days. Half of 
the participants will use Routine A and half will use Routine B with their first dose of IDeg. 
Everyone will wear a continuous glucose monitor for at least 48 hours before and at least 48 
hours after starting IDeg. There will be 1 visit to the clinic and 5-6 phone calls. You will also go 
to the study pharmacy to pick up your IDeg and study drug (Routine A or Routine B). 
 
You will not personally benefit from being in this study. You can talk with your own doctor 
about taking IDeg. You do not need to be in this study to try it. The main risk is that your blood 
sugar may not be well controlled the first day or two you switch insulin. A rare risk is to have an 
allergic reaction to IDeg. 


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PURPOSE OF THE STUDY 
 
The purpose of this pilot study is to test whether Routine B results in better blood sugar control 
than Routine A. Enough people with T1D taking glargine will be enrolled to have 40 people 
complete the study. If you are eligible to take part in the study, you will receive IDeg for 3-7 
days. You will be randomly assigned (by chance) to receive glargine (Routine B) or placebo (a 
saline solution with no insulin)(Routine A) with your first dose of IDeg. You have an equal 
chance of receiving glargine or placebo. Neither you nor the study staff will know which you are 
taking. The study doctor can access this information if needed for your safety. 
 
STUDY PROCEDURES 
This study will last about 3-5 weeks, with 3 clinic visits and 4 to 6 phone visits. Most visits will 
last about 1 hour. The Visit Schedule below outlines what is done at each visit. 
 
Visit Schedule 
Visit 
1* 
(Telemed) 
2 
3 
 
4 
 
5 
 
6 
 
7 
 
Study Day 
-28 to -1 
0 
1 
3 
4 
6-10 
11-19 
Read & Sign Consent Form 
X 
Diabetes & Medical History 
X 
Current Medications & Supplements 
X 
Vital Signs and Physical Exam 
X 
Dispense/Return Log Book and Glucometer 
X 
X 
Dispense/Return CGM (continuous glucose 
monitor) 
X 
X 
Check or Download CGM 
X 
X 
X 
Dispense Study Drug (glargine or placebo) 
X 
Dispense IDeg 
X 
Review Insulin Dosing 
X 
X 
X 
X 
X 
X 
Review Health and Medication Changes 
X 
X 
X 
X 
X 
X 
* A blood draw is ordered if recent glycemic control or kidney health test results are unavailable. 
Women able to have children will have a urine pregnancy test at this visit. These tests will be 
completed before Visit 2. 
 
The information collected at Visit 1 will show if you are eligible to continue in the study. If you 
need lab tests, we will schedule the blood draw before Visit 2. If you need a urine pregnancy test, 
it will be done at the same time as the blood draw or mailed to your home. There may be reasons 
you cannot be in the study. We will discuss those reasons with you. 
 
At Visit 2 (Day 0), you will be given a glucometer, CGM, and instructions for switching from 
glargine to IDeg. You will start wearing the CGM. You will be asked to fill in a daily study log. 
This will be completed online. If you can’t complete it online you will need to fill in a paper 
version of the study log. We will call you the next day (Day 1) to check that your CGM is 
working and to answer any questions. 


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We will ask you to download your CGM on Day 3 and review the data. If there is enough data, 
you will pick up the IDeg and study drug from the study pharmacy and start your first dose of 
IDeg with the study drug at bedtime of Day 3. If more data is needed, you will continue your 
glargine and CGM use. CGM data will be re-checked on Day 5. 
 
On Day 4, we will call the morning after your first dose of IDeg with study drug. We will ask 
about the doses and time taken. If the IDeg and study drug were not started on Day 3 or if the 
dose or timing was wrong, the Day 4 phone call will be re-scheduled. If Day 4 is rescheduled  
and you used your single dose of study drug, you will need to pick up a new one at the 
pharmacy. 
 
Study Days 3 and 4 may be repeated once. If there is not enough CGM data or if starting the 
IDeg with study drug is missed or wrong a second time, you will be discontinued from the study. 
 
You will continue taking IDeg until Visit 6. At Visit 6, you will be asked to return the CGM by 
mail in a prepaid envelope provided to you at Visit 2. If you used a paper study log, you will 
return it in the same envelope. We will give you instructions for switching back to glargine. You 
will be called 1 week later to see if you have any questions or concerns. You should follow up 
with your diabetes doctor for any further insulin adjustments you need. 
 
Study Procedures: 
During the study, you should use the study glucose meter to check your blood sugar. If you have 
your own CGM that is calibrated, check your blood sugar at least 2 times daily. Otherwise, you 
should check your blood sugar 4 times daily. 
 
You will be asked to continue your normal diet, alcohol consumption and exercise routines 
during the study. Starting at Visit 2, you should not make changes in your routines until Visit 3. 
 
At each visit, we will ask you about your insulin use and about changes in your health and 
medications. 
 
Blood tests: At Visit 1, if needed, we will order blood tests to be done at a lab. They will collect 
1-2 teaspoons of blood if your medical record does not have test results for: 
• A1c (glycemic control) in the last 90 days 
• eGFR (kidney health) in the last year 
 
Vital signs and Physical exam: We will measure your blood pressure, pulse, weight and height at 
Visit 2. A focused physical exam will also be done to check your insulin injection sites. 
 
Study Log: You will start filling in a study log at Visit 2. You will be asked to record your daily 
insulin doses, the times taken, blood sugar tests, carbohydrates and amount of exercise. The log 
has forms for recording information about low blood sugars. This asks you about your  
symptoms and, if you needed help, when the symptoms occurred and treatment information. The 
study log will be completed online. You will get a daily email with a link to your daily log. If 
needed, we can provide a paper study log. 


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Continuous Glucose Monitor (CGM): At Visit 2, you will be given a blinded CGM. You will be 
taught how to use it. You cannot see your blood sugar results on this CGM. If you have your 
own CGM you can wear it at the same time as the study CGM. You will start wearing the CGM 
at Visit 2 and wear it at all times until Visit 6. At Visit 6, we will ask you to return the CGM via 
mail and download the data. You will be given enough CGM supplies to last for about 1 week. 
 
On Day 3, you will be asked to download your CGM. If there is less than 38 hours of usable 
data, you will be asked to continue wearing the CGM and using your current insulin for another 
2 days.  The CGM will be downloaded again to check for usable data.  If there is not enough,  
you will be discontinued from the study. 
 
Insulin Dosing and Study Drug: 
If you are not taking at least one daily glargine dose at bedtime, you will be switched to bedtime 
dosing a week before Visit 2. 
 
On Study Day 3, the research pharmacy will give you enough IDeg for 3-4 days and one dose of 
study drug (glargine or placebo). We will calculate the dose of IDeg and study drug. Your IDeg 
dose will be 80% of the dose of glargine you were taking. Your dose of study drug will be 50% 
of your current glargine dose. You will take the study drug with your first dose of IDeg at 
bedtime on Study Day 3. You will not start the IDeg on Day 3 until the study staff confirms you 
should start it. You may need to collect more CGM data before starting the IDeg. 
 
If you missed taking the IDeg and study drug at bedtime on Day 3, you will be asked to start 
them on Day 4. If the wrong dose of IDeg or study drug was taken, or they were taken at the 
wrong time, we will ask you to switch back to your original glargine for 3 days. After this 3-day 
“wash-out” period, you will pick up a new dose of study drug if needed and take IDeg and study 
drug on Day 7 at bedtime. 
 
For 48 hours before and after starting the IDeg, you will be asked to not use any 
correctional insulin (to lower high blood glucose readings) unless your blood glucose is > 
250. This includes correctional insulin at mealtimes and otherwise. This will help us see any 
differences in blood sugar control between the people who start IDeg with a “bridging” dose of 
glargine to those who start IDeg alone. 
 
You will continue taking IDeg until Visit 6. At Visit 6 you will be instructed to switch back to 
glargine. We will calculate your insulin doses as follows: 
• If you used glargine once daily: About 24 hours after your last dose of IDeg, you will 
take 50% of your usual glargine dose at bedtime. At 48 hours after your last dose of 
IDeg, you will return to your original bedtime dose of glargine. 
• If you used glargine twice daily: About 24 hours after your last dose of IDeg, you will 
take 50% of your usual dose of glargine at bedtime. You will again take 50% of your 
usual glargine dose about 36 hours after your last dose of IDeg. At 48 hours after your 
last dose of IDeg, you will return to your original twice daily doses of glargine. 


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RISKS, STRESS, OR DISCOMFORT 
 
Low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia): These are the most 
common risks for anyone who needs to use insulin. 
 
Symptoms of low blood sugar can include: 
Early signs: 
• feeling hungry, very tired, 
shaky, worried or irritable 
• feeling of strong or fast 
heartbeat 
• pale skin and sweating 
• finding it hard to think. 
Signs during the night: 
• damp sheets or clothes 
from sweating 
• nightmares 
• feeling tired, irritable or 
confused when waking 
up. 
Signs of severe low blood sugar: 
• feeling confused 
• strange behavior such as 
slurred speech or being clumsy 
• problems with your sight 
• fits or passing out. 
Symptoms of high blood sugar can include: 
• being very thirsty 
• change in vision 
• needing to pee more often 
• weakness, sleepiness or confusion. 
 
Low blood sugar is more likely to happen if you exercise more than usual, eat too little or miss a 
meal, or drink alcohol. If you have any signs of low blood sugar, eat or drink something 
sweet (juice, soft drinks with real sugar, sweets, glucose tablets). If this does not work, talk 
to a doctor or the study staff right away. 
 
IDeg (insulin degludec): Low or high blood sugar is the most common risk for anyone taking 
insulin. There is a small chance you may have an allergic reaction to IDeg. Serious allergic 
reaction is a very rare side effect. This may become severe and could lead to death if not treated. 
If you have any signs of a serious allergic reaction, stop taking the study medicine and get 
emergency help right away. 
 
Allery symptoms can include: 
Signs of mild allergy: 
• rash, redness, hives 
• itching 
• wheezing. 
Signs of a serious allergic reaction 
• swelling of your throat and face, 
• breathing problems, fast heart-beat, pale and cold skin, 
• feeling dizzy or weak. 
 
Switching between insulins: When you switch from one insulin to another, there is an increased 
risk of high or low blood sugars for a few days. 
 
CGM: The CGM sensor is inserted into the skin. Some people find this painful. Rarely, a skin 
infection can occur where the sensor is inserted. You may have itchiness, redness, bleeding, and 
bruising where the sensor is inserted. An allergy to the tape that holds the sensor to the skin is 
possible. Very rarely, the sensor or needle may break under your skin. If this happens, you 
should contact your study doctor about what to do. 


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Fingerstick: The fingerstick blood sugar tests may cause pain or bleeding. Some people may get 
a bruise at the site of the fingerstick. Very rarely, the site of a fingerstick may get infected. 
 
Blood draw: If you have a blood draw at Visit 1, you may feel a little discomfort, bruising, 
bleeding or swelling where the needle goes in. There is a very small chance of infection where 
the needle goes in. 
 
Pregnancy: If you learn you are pregnant during the study, please let the study doctor know 
immediately. We will report any pregnancy to NovoNordisk, as they are providing the IDeg.  
The study doctor will follow the progress of the pregnancy and may require access to your 
infant’s and/or your medical records for additional follow-up after delivery. 
 
COVID-19: The only visit in which you will interact with study staff directly is visit 2, at which 
time, staff will take all precautions of masking, physical distancing and hand-washing before 
interacting with you. During the physical exam the duration of close contact with study staff will 
also be less than a few minutes, since it is only a focused physical exam. 
 
ALTERNATIVES TO TAKING PART IN THIS STUDY 
 
You do not have to be in this study to change your insulin glargine to insulin degludec. You can 
ask your diabetes doctor about changing your insulin at your next clinic appointment. 
 
BENEFITS OF THE STUDY 
 
You will not personally benefit from being in this study. You will get to try IDeg for a 3-7 days. 
This research will help us learn more about whether using a “bridging” dose helps blood sugar 
control when starting IDeg. Information from this study may help future research into how to 
best switch from one type of insulin to another. 
 
SOURCE OF FUNDING 
 
The University of Washington is receiving a grant for this Investigator-Initiated study from the 
University of Washington School of Medicine and funds are supported by NovoNordisk. 
NovoNordisk is providing the IDeg for this study. 
 
CONFIDENTIALITY OF RESEARCH INFORMATION 
 
Information collected for this study will be confidential. Study data reported to NovoNordisk 
will be coded, it will not have your name on it. The account we set up for the study CGM will 
also be coded and not identify you. 
 
Government or university staff sometimes review studies such as this one to make sure they are 
being done safely and legally. If a review of this study takes place, your records may be 
examined. The reviewers will protect your privacy. The study records will not be used to put  
you at legal risk of harm. 


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If you have a serious health problem during this study, we may ask your permission to access the 
medical records related to it. We may need to report your health problem to the government, 
university staff, and/or NovoNordisk. Your study and medical records may be reviewed. The 
reviewers will protect your privacy. 
 
Your participation in this study will be noted in your UW medical record. UW Medicine staff 
and people who have legal access to your medical record will be able to see it. Anything you 
report to us that is related to your diabetes or current health care may be recorded in your 
medical record. We do not record other study data in your medical record. 
 
Your identity will not be shared in any reports or publications resulting from this study. 
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
USE OF INFORMATION AND SPECIMENS 
 
You will not receive individual results from this study. If you are interested in what we learn 
from this study as a whole, you can opt in to be contacted with results. 
□ I am interested in hearing about study results 
 
Information from this study might be used for future studies. Anything that identifies you will be 
removed. If we do so, that information may be used for future research studies or given to 
another researcher without getting additional permission from you. It is also possible that in the 
future we may want to use or share study information that might identify you. If we do, a review 
board will decide whether or not we need to get additional permission from you. 
 
Commercial Profit 
The data we collect as part of this research may be used in the future for commercial profit. 
There is no plan to share this profit with you. 
 
OTHER INFORMATION 
 
You may refuse to take part in this study. You are free to withdraw from it at any time. Leaving 
the study will cause no penalty or loss of benefits to which you are otherwise entitled. Leaving 
the study will not affect your clinical care. We will keep any study data collected before you 
withdraw from the study. There are no blood or other samples saved as part of this study. 


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The study will provide you with a glucose meter and tests strips to use during the study. The 
study will also provide you with the IDeg and the “bridging” dose of glargine or placebo. You 
will not need to pay for these. You will be asked to return the glucose meter, unused IDeg and 
study drug containers at your last study visit. 
 
We will pay for your parking when you come to the clinic for study visits. You will receive $50 
when you complete the study. You (or your insurance) will not have to pay for any of the visits 
or tests that are part of this study. 
 
RESEARCH-RELATED INJURY 
 
If you think you have a medical problem or illness related to this research, contact Arthi 
Thirumalai (pager: 206-314-6080) or Jing Chao (pager: 206-314-2208) right away. If you cannot 
reach them, call the hospital operator at 206-598-6190 and ask for the diabetes care doctor on 
call. They will treat you or refer you for treatment at a UW Medicine facility. 
 
The costs of the treatment may be billed to you or your health insurance just like other medical 
costs, or it may be covered by the UW’s discretionary Human Subjects Assistance Program 
(HSAP), depending on a number of factors. The researcher may request HSAP coverage by 
following established procedures. If you wish to request HSAP coverage yourself, contact the 
researcher or the UW Human Subjects Division at hsdinfo@uw.edu or 206-543-0098. You may 
also call collect to the UW Human Subjects Division at 206-221-5940 if you do not otherwise 
have access to a telephone. Ask the researcher if you would like information about the limits and 
conditions of the HSAP. The UW does not normally provide any other form of compensation for 
injury. However, the law may allow you to seek payment for injury-related expenses if they are 
caused by malpractice or the fault of the researchers. You do not waive any right to seek 
payment by signing this consent form. We will bill your health insurance for treating problems 
that result from your diabetes or from standard clinical care. If you have no health insurance or 
your insurance refuses to pay, we will bill you. 
 
 
Printed name of study staff obtaining consent 
Signature Date 
 
Subject’s statement 
This study has been explained to me. I volunteer to take part in this research. I have had a  
chance to ask questions. If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form. If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098 or call collect at (206) 221-5940. I give permission to the 
researchers to use my medical records as described in this consent form. I will receive a copy of 
this consent form. 
 
 
Printed name of subject 
Signature of subject 
Date 
 
Copies to: 
Researcher; Subject; Subject’s Medical Record (if applicable)