Trial Outcomes & Findings for A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics (NCT NCT02197520)
NCT ID: NCT02197520
Last Updated: 2018-11-01
Results Overview
During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.
COMPLETED
PHASE1
24 participants
Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp
2018-11-01
Participant Flow
Participant milestones
| Measure |
Sequence AB
A: Insulin peglispro, administered SC for 33 days B. Insulin glargine, administered SC for 33 days
|
Sequence BA
B. Insulin glargine, administered SC for 33 days A: Insulin peglispro, administered SC for 33 days
|
|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
|
Period 1
COMPLETED
|
11
|
12
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
11
|
12
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Sequence AB
A: Insulin peglispro, administered SC for 33 days B. Insulin glargine, administered SC for 33 days
|
Sequence BA
B. Insulin glargine, administered SC for 33 days A: Insulin peglispro, administered SC for 33 days
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 2
Adverse Event
|
0
|
2
|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
All participants who received Insulin peglispro, administered SC for 33 days then Insulin glargine, administered SC for 33 days or Insulin glargine, administered SC for 33 days then Insulin peglispro, administered SC for 33 days
|
|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clampPopulation: All participants who received at least 1 dose of study drug and had evaluable PD parameters.
During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.
Outcome measures
| Measure |
Insulin Peglispro
n=21 Participants
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=22 Participants
Insulin glargine, a once daily SC
|
|---|---|---|
|
Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
High Dose Insulin
|
59.09 milligram*hour per deciliter
Standard Deviation 10.48
|
55.52 milligram*hour per deciliter
Standard Deviation 16.50
|
|
Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
Low Dose Insulin
|
17.22 milligram*hour per deciliter
Standard Deviation 6.24
|
19.67 milligram*hour per deciliter
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfastPopulation: All participants who received at least 1 dose of study drug and had evaluable PD parameters.
Outcome measures
| Measure |
Insulin Peglispro
n=23 Participants
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=22 Participants
Insulin glargine, a once daily SC
|
|---|---|---|
|
Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
10% Insulin Lispro Dose
|
437.78 milligram*hour per deciliter
Standard Deviation 147.47
|
398.26 milligram*hour per deciliter
Standard Deviation 159.89
|
|
Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
20% Insulin Lispro Dose
|
334.23 milligram*hour per deciliter
Standard Deviation 165.96
|
343.54 milligram*hour per deciliter
Standard Deviation 182.13
|
|
Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
30% Insulin Lispro Dose
|
244.68 milligram*hour per deciliter
Standard Deviation 136.01
|
239.83 milligram*hour per deciliter
Standard Deviation 175.54
|
SECONDARY outcome
Timeframe: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfastPopulation: All participants who received at least 1 dose of study drug and had evaluable PK parameters.
Outcome measures
| Measure |
Insulin Peglispro
n=21 Participants
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=21 Participants
Insulin glargine, a once daily SC
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro
|
839 picomol*hour per liter
Standard Deviation 47
|
835 picomol*hour per liter
Standard Deviation 64
|
SECONDARY outcome
Timeframe: Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfastPopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Insulin Peglispro
n=23 Participants
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=22 Participants
Insulin glargine, a once daily SC
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen
|
33700 nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
35700 nanograms*hour per milliliter
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfastPopulation: All participants who received at least 1 dose of study drug and had a VAS score.
VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount. The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints.
Outcome measures
| Measure |
Insulin Peglispro
n=21 Participants
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=21 Participants
Insulin glargine, a once daily SC
|
|---|---|---|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: Waking
|
30.2 millimeters
Standard Deviation 23.9
|
34.4 millimeters
Standard Deviation 25.6
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: Pre-breakfast
|
41.5 millimeters
Standard Deviation 30.1
|
51.4 millimeters
Standard Deviation 32.8
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: Pre-breakfast
|
43.9 millimeters
Standard Deviation 27.7
|
51.5 millimeters
Standard Deviation 30.2
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger:3 hour Post-breakfast
|
34.8 millimeters
Standard Deviation 26.5
|
29.2 millimeters
Standard Deviation 20.8
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: Waking
|
25.7 millimeters
Standard Deviation 23.2
|
38.6 millimeters
Standard Deviation 31.3
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: 1 hour Post-breakfast
|
7.8 millimeters
Standard Deviation 12.8
|
6.2 millimeters
Standard Deviation 16.4
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: 1 hour Post-breakfast
|
8.7 millimeters
Standard Deviation 12.2
|
6.0 millimeters
Standard Deviation 11.6
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: 2 hour Post-breakfast
|
19.7 millimeters
Standard Deviation 23.5
|
14.9 millimeters
Standard Deviation 19.4
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: 2 hour Post-breakfast
|
20.7 millimeters
Standard Deviation 24.2
|
16.3 millimeters
Standard Deviation 17.4
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: 3 hour Post-breakfast
|
35.6 millimeters
Standard Deviation 27.3
|
31.1 millimeters
Standard Deviation 20.6
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: 4 hour Post-breakfast
|
46.6 millimeters
Standard Deviation 27.8
|
48.0 millimeters
Standard Deviation 28.3
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: 4 hour Post-breakfast
|
48.2 millimeters
Standard Deviation 27.5
|
48.5 millimeters
Standard Deviation 28.2
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Hunger: 5 hour Post-breakfast
|
56.8 millimeters
Standard Deviation 28.6
|
55.5 millimeters
Standard Deviation 34.1
|
|
Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29
Food amount: 5 hour Post-breakfast
|
57.5 millimeters
Standard Deviation 27.2
|
53.4 millimeters
Standard Deviation 34.4
|
SECONDARY outcome
Timeframe: Day 33 during euglycemic 2-step hyperinsulinemic clampPopulation: No participant analyzed because Outcome Measure was incorrectly registered.
Outcome measures
Outcome data not reported
Adverse Events
Insulin Peglispro
Insulin Glargine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Peglispro
n=24 participants at risk
Insulin peglispro, a once daily SC
|
Insulin Glargine
n=23 participants at risk
Insulin glargine, a once daily SC
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1
|
17.4%
4/23 • Number of events 5
|
|
General disorders
Catheter site haemorrhage
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Catheter site related reaction
|
12.5%
3/24 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Injection site haemorrhage
|
4.2%
1/24 • Number of events 1
|
8.7%
2/23 • Number of events 3
|
|
General disorders
Vessel puncture site bruise
|
12.5%
3/24 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Number of events 3
|
21.7%
5/23 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
12.5%
3/24 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2
|
13.0%
3/23 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60