Trial Outcomes & Findings for A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue (NCT NCT02109029)
NCT ID: NCT02109029
Last Updated: 2019-03-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
16, 20, 24, and 28 hours postdose
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Part A: Cohort 1 Insulin Peglispro Low/High
Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1 and received a priming dose of 8.00 U and 4.50/h constant infusion with at least 6 days between doses) as treatment 2.
|
Part A: Cohort 1 Insulin Peglispro High/Low
Participants received a priming dose of 8.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1, and an IV priming dose of 2.00 U and 0.92 U/hour constant infusion as treatment 2.
|
Part A: Cohort 2 Insulin Peglispro Intermediate Dose 1 and 2
Participants received a priming dose of 4.00 U and 1.84 U/h a constant intravenous (IV) of insulin peglispro for 36 hours as treatment 1, and a 6.00 U priming dose and constant infusion of 2.76U/h of insulin peglispro as treatment 2.
|
Part A: Cohort 2 Insulin Peglispro, Intermediate Dose 2 and 1
Participants received a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro as treatment 1, and 4.00 U and 1.84 U/h constant infusion of insulin peglispro for 36 hours as treatment 2.
|
Part B: Insulin Peglispro/Human Insulin
Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours as treatment 1 and 6 pmol/kg/min constant infusion of human insulin as treatment 2.
|
Part B: Human Insulin/Insulin Peglispro
Participant received 6 pmol/kg/min constant infusion of human insulin IV as treatment 1 and a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro and a constant infusion for 36 hours as treatment 2.
|
|---|---|---|---|---|---|---|
|
Part A
STARTED
|
2
|
2
|
4
|
4
|
0
|
0
|
|
Part A
Received One Dose of Study Drug
|
2
|
2
|
4
|
4
|
0
|
0
|
|
Part A
COMPLETED
|
2
|
2
|
4
|
4
|
0
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Part B
Received at Least One Dose of Study Drug
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1 Insulin Peglispro Low/High
Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1 and received a priming dose of 8.00 U and 4.50/h constant infusion with at least 6 days between doses) as treatment 2.
|
Part A: Cohort 1 Insulin Peglispro High/Low
Participants received a priming dose of 8.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1, and an IV priming dose of 2.00 U and 0.92 U/hour constant infusion as treatment 2.
|
Part A: Cohort 2 Insulin Peglispro Intermediate Dose 1 and 2
Participants received a priming dose of 4.00 U and 1.84 U/h a constant intravenous (IV) of insulin peglispro for 36 hours as treatment 1, and a 6.00 U priming dose and constant infusion of 2.76U/h of insulin peglispro as treatment 2.
|
Part A: Cohort 2 Insulin Peglispro, Intermediate Dose 2 and 1
Participants received a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro as treatment 1, and 4.00 U and 1.84 U/h constant infusion of insulin peglispro for 36 hours as treatment 2.
|
Part B: Insulin Peglispro/Human Insulin
Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours as treatment 1 and 6 pmol/kg/min constant infusion of human insulin as treatment 2.
|
Part B: Human Insulin/Insulin Peglispro
Participant received 6 pmol/kg/min constant infusion of human insulin IV as treatment 1 and a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro and a constant infusion for 36 hours as treatment 2.
|
|---|---|---|---|---|---|---|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
Baseline characteristics by cohort
| Measure |
Part A Low/High Insulin Peglispro
n=4 Participants
Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 8.00 U priming dose and 4.50 U/h constant IV infusionconstant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses.
|
Part A Intermediate Insulin Peglispro
n=8 Participants
Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 6.00 U priming dose and 2.76U/h constant IV infusion constant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses.
|
Part B
n=12 Participants
Participants first received a priming dose of 8.00 U followed by 2.76 U/h constant intravenous (IV) infusion of LY2605541 for 36 hours or 6 pmol/kg/min constant infusion of human insulin with up to 2 weeks between doses.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
39.0 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
40.1 years
STANDARD_DEVIATION 11.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
BMI
|
27.57 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 2.09 • n=93 Participants
|
25.98 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 1.87 • n=4 Participants
|
26.73 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 1.28 • n=27 Participants
|
26.62 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 1.65 • n=483 Participants
|
|
Body Weight
|
83.93 kilograms (kg)
STANDARD_DEVIATION 12.63 • n=93 Participants
|
83.80 kilograms (kg)
STANDARD_DEVIATION 8.79 • n=4 Participants
|
83.56 kilograms (kg)
STANDARD_DEVIATION 8.60 • n=27 Participants
|
83.70 kilograms (kg)
STANDARD_DEVIATION 8.93 • n=483 Participants
|
|
HbA1c
|
7.20 percentage of Glycated hemoglobin
STANDARD_DEVIATION 0.88 • n=93 Participants
|
7.51 percentage of Glycated hemoglobin
STANDARD_DEVIATION 0.90 • n=4 Participants
|
7.53 percentage of Glycated hemoglobin
STANDARD_DEVIATION 0.54 • n=27 Participants
|
7.47 percentage of Glycated hemoglobin
STANDARD_DEVIATION 0.71 • n=483 Participants
|
PRIMARY outcome
Timeframe: 16, 20, 24, and 28 hours postdosePopulation: All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Insulin Peglispro
n=10 Participants
Participants received a priming dose of 2.00 U LY2605541 followed by a constant infusion of 0.92 U/h for up to 36 hours.
|
Human Insulin
n=11 Participants
Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours
|
|---|---|---|
|
Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
|
11200 picomol per liter (pmol/L)
Geometric Coefficient of Variation 23
|
425 picomol per liter (pmol/L)
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: 16, 20, 24, and 28 hours postdosePopulation: All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data.
Absolute concentration of ISF of insulin peglispro and human insulin.
Outcome measures
| Measure |
Insulin Peglispro
n=10 Participants
Participants received a priming dose of 2.00 U LY2605541 followed by a constant infusion of 0.92 U/h for up to 36 hours.
|
Human Insulin
n=11 Participants
Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours
|
|---|---|---|
|
Part B: Pharmacokinetics: ISF-to-Serum Concentrations
|
1428.4 picomol per liter (pmol/L)
|
137.9 picomol per liter (pmol/L)
|
Adverse Events
Part A: Insulin Peglispro 2U
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Insulin Peglispro 4U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Insulin Peglispro 6U
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Insulin Peglispro 8U
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Insulin Peglispro
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Human Insulin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Insulin Peglispro 2U
n=4 participants at risk
Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours.
|
Part A: Insulin Peglispro 4U
n=8 participants at risk
Participants received a priming dose of 4.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours.
|
Part A: Insulin Peglispro 6U
n=8 participants at risk
Participant received a priming dose of 6.00 U and 1.84 constant IV infusion of insulin peglispro respectively, for 36 hours.
|
Part A: Insulin Peglispro 8U
n=4 participants at risk
Participant received a priming dose of 8.00 U and 2.76 constant IV infusion of insulin peglispro respectively, for 36 hours.
|
Part B: Insulin Peglispro
n=12 participants at risk
Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours.
|
Part B: Human Insulin
n=11 participants at risk
Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/12 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
9.1%
1/11 • Number of events 1 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
16.7%
2/12 • Number of events 2 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/11 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
8.3%
1/12 • Number of events 1 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/11 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
8.3%
1/12 • Number of events 2 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
9.1%
1/11 • Number of events 2 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
25.0%
2/8 • Number of events 2 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/12 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/11 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/12 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
9.1%
1/11 • Number of events 1 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
12.5%
1/8 • Number of events 1 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/12 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/11 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/8 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
12.5%
1/8 • Number of events 1 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/4 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/12 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
0.00%
0/11 • Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60