Trial Outcomes & Findings for Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose (NCT NCT04623086)
NCT ID: NCT04623086
Last Updated: 2024-02-28
Results Overview
Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
48 hours prior to 48 hours after 1st dose of degludec insulin
Results posted on
2024-02-28
Participant Flow
59 participants were screened, 37 were randomized, 37 completed the study.
12 participants did not meet study inclusion/exclusion criteria and were screen failures. 47 participants started study procedures but only 37 were randomized.
Participant milestones
| Measure |
Insulin Glargine and Insulin Degludec
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
Unassigned Group
Enrolled participants who discontinued the study prior to randomization to any treatment group
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
10
|
|
Overall Study
COMPLETED
|
19
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
Insulin Glargine and Insulin Degludec
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
Unassigned Group
Enrolled participants who discontinued the study prior to randomization to any treatment group
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
10
|
Baseline Characteristics
Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
Baseline characteristics by cohort
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 14 • n=5 Participants
|
44 years
STANDARD_DEVIATION 16 • n=7 Participants
|
47 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Duration of Diabetes
|
26 years
STANDARD_DEVIATION 21 • n=5 Participants
|
17 years
STANDARD_DEVIATION 16 • n=7 Participants
|
22 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Weight
|
73.7 kilograms
STANDARD_DEVIATION 19.2 • n=5 Participants
|
87.7 kilograms
STANDARD_DEVIATION 23.6 • n=7 Participants
|
80 kilograms
STANDARD_DEVIATION 22.2 • n=5 Participants
|
|
Body mass index
|
24.9 kilograms/meters squared
STANDARD_DEVIATION 6 • n=5 Participants
|
27.1 kilograms/meters squared
STANDARD_DEVIATION 5 • n=7 Participants
|
26 kilograms/meters squared
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Hemoglobin A1c
|
6.7 percent glycated hemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
6.9 percent glycated hemoglobin
STANDARD_DEVIATION 1 • n=7 Participants
|
6.8 percent glycated hemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Total Daily Dose of Insulin
|
0.6 Units/kilogram body weight/day
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.8 Units/kilogram body weight/day
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.7 Units/kilogram body weight/day
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Creatinine
|
0.82 milligrams/deciliter
STANDARD_DEVIATION 0.21 • n=5 Participants
|
0.84 milligrams/deciliter
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.83 milligrams/deciliter
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Time in range (TIR)
|
65.4 percent of time measured
STANDARD_DEVIATION 21.6 • n=5 Participants
|
69.4 percent of time measured
STANDARD_DEVIATION 17.2 • n=7 Participants
|
67.4 percent of time measured
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Coefficient of Variation of Glucose
|
31.1 percent of variation
STANDARD_DEVIATION 6.7 • n=5 Participants
|
31.4 percent of variation
STANDARD_DEVIATION 8.3 • n=7 Participants
|
31.2 percent of variation
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Time above range-1 (TAR-1)
|
26.8 percent of time measured
STANDARD_DEVIATION 17.2 • n=5 Participants
|
19.4 percent of time measured
STANDARD_DEVIATION 13.7 • n=7 Participants
|
23.2 percent of time measured
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Time above range-2 (TAR-2)
|
5.5 percent of time measured
STANDARD_DEVIATION 7.1 • n=5 Participants
|
5.9 percent of time measured
STANDARD_DEVIATION 8 • n=7 Participants
|
5.7 percent of time measured
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Time below range-1 (TBR-1)
|
2.1 percent of time measured
STANDARD_DEVIATION 2.1 • n=5 Participants
|
4.1 percent of time measured
STANDARD_DEVIATION 5.7 • n=7 Participants
|
3 percent of time measured
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Time below range-2 (TBR-2)
|
0.3 percent of time measured
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.6 percent of time measured
STANDARD_DEVIATION 5 • n=7 Participants
|
0.9 percent of time measured
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Nocturnal time in range (N-TIR)
|
60.3 percent of time measured
STANDARD_DEVIATION 28.9 • n=5 Participants
|
74.4 percent of time measured
STANDARD_DEVIATION 25.5 • n=7 Participants
|
67.2 percent of time measured
STANDARD_DEVIATION 27.8 • n=5 Participants
|
|
Correction Boluses
|
0.9 Number of boluses
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.5 Number of boluses
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.2 Number of boluses
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours prior to 48 hours after 1st dose of degludec insulinPopulation: Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Mean Change in Percent Time in Range
|
2 percentage of time in measured period
Standard Deviation 14.7
|
-6.1 percentage of time in measured period
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: 48 hours prior to 48 hours after 1st dose of degludec insulinPopulation: Change in coefficient of variation of glucose (CV) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Change in coefficient of variation of glucose (CV) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Coefficient of Variation (CV) of Percent-time-in-range
|
3 percent of variation
Standard Deviation 6.9
|
-1.1 percent of variation
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 4 days: Outcome Measure Time Frame 48 hours prior to 48 hours after 1st dose of degludec insulinChange in nocturnal (defined as midnight to 0600 hours) time in range (glucose in 70-180 mg/dL range) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR)
|
5.1 percentage of time in measured period
Standard Deviation 34.6
|
-7 percentage of time in measured period
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: 4 daysChange in time above range (glucose in 181-250 mg/dL range, TAR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Percent Time Above 180 mg/dL (TAR-1)
|
5.4 percentage of time in measured period
Standard Deviation 15.4
|
6.5 percentage of time in measured period
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 4 daysChange in time above range (glucose above 250 mg/dL range, TAR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Time Above Range-2 (TAR-2)
|
2.2 percentage of time in measured period
Standard Deviation 6.8
|
1.9 percentage of time in measured period
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 48 hours prior to 48 hours after 1st dose of degludec insulinChange in time below range (glucose 54-70 mg/dL range, TBR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Time Below Range-1 (TBR-1)
|
1.1 percentage of time in measured period
Standard Deviation 3.5
|
-1.5 percentage of time in measured period
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 48 hours prior to 48 hours after 1st dose of degludec insulinChange in time below range (glucose below 54 mg/dL range, TBR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=19 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=18 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Time Below Range-2 (TBR-2)
|
0.3 percentage of time in measured period
Standard Deviation 0.7
|
-0.8 percentage of time in measured period
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 48 hours prior to 48 hours after 1st dose of degludec insulinChange in the number of daily correction boluses administered in the 48 hours before and 48 hours after the 1st dose of degludec insulin, as noted on insulin logs maintained by participants
Outcome measures
| Measure |
Insulin Glargine and Insulin Degludec
n=17 Participants
Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Insulin Glargine: Insulin Glargine injection
|
Insulin Degludec and Placebo
n=16 Participants
Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily
Insulin Degludec: Insulin Degludec injection
Placebo: 9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
|
|---|---|---|
|
Correction Boluses
|
0 boluses in 48 hours measured
Standard Deviation 1.0
|
0 boluses in 48 hours measured
Standard Deviation 1.6
|
Adverse Events
Insulin Glargine and Insulin Degludec
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Degludec and Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Entire Study Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place