Trial Outcomes & Findings for A Study of LY2605541 Versus Insulin Glargine on Blood Sugar (NCT NCT01654380)
NCT ID: NCT01654380
Last Updated: 2019-03-08
Results Overview
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-\[last 2 hours of EGP/basal EGP\])\*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Results posted on
2019-03-08
Participant Flow
Participant milestones
| Measure |
Part A, Cohort A: LY2605541 First, Then Insulin Glargine
LY2605541: Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours.
Insulin glargine: Healthy participants received 30 milliunits/meter squared/minute \[mU/m\^2/min\]) administered IV over 8 hours in Period 4
|
Part A, Cohort B: LY2605541 First, Then Insulin Glargine
LY2605541: Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours.
Insulin glargine: Healthy participants received 20 mU/m\^2/min administered IV over 8 hours in Period 4
|
Part B: LY2605541
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours.
|
Part B: Insulin Glargine
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods and received 20 mU/m\^2/min in 1 of 4 Periods, administered IV over 8 hours.
|
|---|---|---|---|---|
|
Part A, Period 1
STARTED
|
4
|
4
|
0
|
0
|
|
Part A, Period 1
Received at Least 1 Dose of Study Drug
|
4
|
4
|
0
|
0
|
|
Part A, Period 1
COMPLETED
|
4
|
4
|
0
|
0
|
|
Part A, Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part A, Washout of at Least 6 Days
STARTED
|
4
|
4
|
0
|
0
|
|
Part A, Washout of at Least 6 Days
COMPLETED
|
4
|
4
|
0
|
0
|
|
Part A, Washout of at Least 6 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part A, Period 2
STARTED
|
4
|
4
|
0
|
0
|
|
Part A, Period 2
COMPLETED
|
4
|
4
|
0
|
0
|
|
Part A, Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part A, Period 3
STARTED
|
4
|
4
|
0
|
0
|
|
Part A, Period 3
COMPLETED
|
4
|
4
|
0
|
0
|
|
Part A, Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part A, Period 4
STARTED
|
4
|
4
|
0
|
0
|
|
Part A, Period 4
COMPLETED
|
4
|
4
|
0
|
0
|
|
Part A, Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B, Period 1
STARTED
|
0
|
0
|
7
|
7
|
|
Part B, Period 1
Received at Least 1 Dose of Study Drug
|
0
|
0
|
7
|
7
|
|
Part B, Period 1
COMPLETED
|
0
|
0
|
6
|
7
|
|
Part B, Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Part B, Washout of at Least 6 Days
STARTED
|
0
|
0
|
6
|
7
|
|
Part B, Washout of at Least 6 Days
COMPLETED
|
0
|
0
|
6
|
7
|
|
Part B, Washout of at Least 6 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B, Period 2
STARTED
|
0
|
0
|
6
|
7
|
|
Part B, Period 2
COMPLETED
|
0
|
0
|
6
|
7
|
|
Part B, Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B, Period 3
STARTED
|
0
|
0
|
6
|
7
|
|
Part B, Period 3
COMPLETED
|
0
|
0
|
6
|
7
|
|
Part B, Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B, Period 4
STARTED
|
0
|
0
|
6
|
7
|
|
Part B, Period 4
COMPLETED
|
0
|
0
|
6
|
7
|
|
Part B, Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A, Cohort A: LY2605541 First, Then Insulin Glargine
LY2605541: Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours.
Insulin glargine: Healthy participants received 30 milliunits/meter squared/minute \[mU/m\^2/min\]) administered IV over 8 hours in Period 4
|
Part A, Cohort B: LY2605541 First, Then Insulin Glargine
LY2605541: Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours.
Insulin glargine: Healthy participants received 20 mU/m\^2/min administered IV over 8 hours in Period 4
|
Part B: LY2605541
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours.
|
Part B: Insulin Glargine
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods and received 20 mU/m\^2/min in 1 of 4 Periods, administered IV over 8 hours.
|
|---|---|---|---|---|
|
Part B, Period 1
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
Baseline characteristics by cohort
| Measure |
Part A
n=8 Participants
All participants who received at least 1 dose of study drug in Part A of the study.
|
Part B
n=14 Participants
All participants who received at least 1 dose of study drug in Part B of the study.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)Population: Participants who received at least 1 dose of study drug with evaluable EGP data
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-\[last 2 hours of EGP/basal EGP\])\*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Outcome measures
| Measure |
15.3 mU/Min LY2605541
n=14 Participants
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 8 hours
|
74.1 mU/Min LY2605541
n=13 Participants
LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
|
10 mU/m^2/Min Insulin Glargine
n=13 Participants
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
20 mU/m^2/Min Insulin Glargine
n=12 Participants
Insulin glargine: Participants with T1DM received 20 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
|---|---|---|---|---|
|
Part B: Glucodynamics: Endogenous Glucose Output
|
64.53 percent of suppression
Standard Deviation 19.35
|
99.23 percent of suppression
Standard Deviation 1.76
|
78.05 percent of suppression
Standard Deviation 17.33
|
97.05 percent of suppression
Standard Deviation 6.47
|
PRIMARY outcome
Timeframe: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)Population: Participants who received at least 1 dose of study drug with evaluable GDR data.
The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Outcome measures
| Measure |
15.3 mU/Min LY2605541
n=14 Participants
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 8 hours
|
74.1 mU/Min LY2605541
n=13 Participants
LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
|
10 mU/m^2/Min Insulin Glargine
n=13 Participants
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
20 mU/m^2/Min Insulin Glargine
n=12 Participants
Insulin glargine: Participants with T1DM received 20 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
|---|---|---|---|---|
|
Part B: Glycodynamics: Glucose Disposal
|
0.68 fold change
Standard Deviation 0.09
|
1.42 fold change
Standard Deviation 0.35
|
0.98 fold change
Standard Deviation 0.39
|
1.85 fold change
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)Population: Participants who received at least 1 dose of study drug with evaluable Rdmax data.
The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Outcome measures
| Measure |
15.3 mU/Min LY2605541
n=14 Participants
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 8 hours
|
74.1 mU/Min LY2605541
n=13 Participants
LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
|
10 mU/m^2/Min Insulin Glargine
n=13 Participants
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
20 mU/m^2/Min Insulin Glargine
n=13 Participants
Insulin glargine: Participants with T1DM received 20 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
|---|---|---|---|---|
|
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
|
1.80 milligrams/minute/kilograms (mg/min/kg)
Geometric Coefficient of Variation 24
|
2.89 milligrams/minute/kilograms (mg/min/kg)
Geometric Coefficient of Variation 23
|
2.15 milligrams/minute/kilograms (mg/min/kg)
Geometric Coefficient of Variation 28
|
3.55 milligrams/minute/kilograms (mg/min/kg)
Geometric Coefficient of Variation 40
|
Adverse Events
Part A, Cohort A: 5.1 mU/Min LY2605541
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort A: 10.2 mU/Min LY2605541
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort A or Cohort B: 15.3 mU/Min LY2605541
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Cohort A: 30 mU/m^2/Min Insulin Glargine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort B: 37.0 mU/Min LY2605541
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Cohort B: 74.1 mU/Min LY2605541
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort B: 20 mU/m^2/Min Insulin Glargine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: 15.3 mU/Min LY2605541
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: 74.1 mU/Min LY2605541
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: 10 mU/m^2/Min Insulin Glargine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: 20 mU/m^2/Min Insulin Glargine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A, Cohort A: 5.1 mU/Min LY2605541
n=4 participants at risk
LY2605541: Healthy participants received 5.1 mU/min in Period 1, administered IV over 8 hours
|
Part A, Cohort A: 10.2 mU/Min LY2605541
n=4 participants at risk
LY2605541: Healthy participants received 10.2 mU/min in Period 2, administered IV over 8 hours
|
Part A, Cohort A or Cohort B: 15.3 mU/Min LY2605541
n=8 participants at risk
LY2605541: Healthy participants received 15.3 mU/min in Period 3 of Part A Cohort A and 15.3 mU/min in Period 1 of Part A Cohort B, administered IV over 8 hours
|
Part A, Cohort A: 30 mU/m^2/Min Insulin Glargine
n=4 participants at risk
Insulin glargine: Healthy participants received 30 mU/m\^2/min administered IV over 8 hours in Period 4
|
Part A, Cohort B: 37.0 mU/Min LY2605541
n=4 participants at risk
LY2605541: Healthy participants received 37.0 mU/min in Period 2 administered IV over 8 hours
|
Part A, Cohort B: 74.1 mU/Min LY2605541
n=4 participants at risk
LY2605541: Healthy participants received 74.1 mU/min in Period 3, administered IV over 8 hours
|
Part A, Cohort B: 20 mU/m^2/Min Insulin Glargine
n=4 participants at risk
Insulin glargine: Healthy participants received 20 mU/m\^2/min administered IV over 8 hours in Period 4
|
Part B: 15.3 mU/Min LY2605541
n=14 participants at risk
LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
|
Part B: 74.1 mU/Min LY2605541
n=13 participants at risk
LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours
|
Part B: 10 mU/m^2/Min Insulin Glargine
n=13 participants at risk
Insulin glargine: Participants with T1DM received 10 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
Part B: 20 mU/m^2/Min Insulin Glargine
n=13 participants at risk
Insulin glargine: Participants with T1DM received 20 mU/m\^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Catheter site pain
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Influenza like illness
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Infusion site discomfort
|
0.00%
0/4
|
0.00%
0/4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Groin abscess
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
0.00%
0/8
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
Nervous system disorders
Syncope
|
0.00%
0/4
|
0.00%
0/4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4
|
0.00%
0/4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
Vascular disorders
Hypertension
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/13
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
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