Back to resultsA Study of LY2605541 Versus Insulin Glargine on Blood Sugar
Primary Purpose
Healthy Volunteers, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2605541
Insulin glargine
Sponsored by
About this trial
This is an interventional other trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All Participants
- Are healthy males or participants with T1DM
- Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
Healthy Participants ONLY
- Are overtly healthy, as determined by medical history and physical examination
- Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening
Participants with T1DM ONLY
- Have a diagnosis of T1DM for at least 1 year based on medical history
- Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)
- Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
- Have had no episodes of severe hypoglycemia in the past 6 months
Exclusion Criteria:
All Participants
- Have a hemoglobin level <12.0 grams/deciliter (g/dL)
- Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study
Healthy Participants ONLY
• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).
Participants with T1DM ONLY
- Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
- Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
- Require a total daily insulin dose exceeding 100 units (U)
- Have fasting triglycerides >400 mg/dL
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Part A, Cohort A; LY2605541
Part A, Cohort A; Insulin Glargine
Part A, Cohort B; LY2605541
Part A, Cohort B; Insulin Glargine
Part B; LY2605541
Part B; Insulin Glargine
Arm Description
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. All periods were separated by a minimum 6-day washout period
Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period
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. All periods were separated by a minimum 6-day washout period.
Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.
Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.
Outcomes
Primary Outcome Measures
Part B: Glucodynamics: Endogenous Glucose Output
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.
Part B: Glycodynamics: Glucose Disposal
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.
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01654380
Brief Title
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
Official Title
Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A, Cohort A; LY2605541
Arm Type
Experimental
Arm Description
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. All periods were separated by a minimum 6-day washout period
Arm Title
Part A, Cohort A; Insulin Glargine
Arm Type
Active Comparator
Arm Description
Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period
Arm Title
Part A, Cohort B; LY2605541
Arm Type
Experimental
Arm Description
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. All periods were separated by a minimum 6-day washout period.
Arm Title
Part A, Cohort B; Insulin Glargine
Arm Type
Active Comparator
Arm Description
Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.
Arm Title
Part B; LY2605541
Arm Type
Experimental
Arm Description
Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
Arm Title
Part B; Insulin Glargine
Arm Type
Active Comparator
Arm Description
Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.
Intervention Type
Drug
Intervention Name(s)
LY2605541
Intervention Description
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).
Intervention Type
Other
Intervention Name(s)
Insulin glargine
Intervention Description
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
Primary Outcome Measure Information:
Title
Part B: Glucodynamics: Endogenous Glucose Output
Description
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.
Time Frame
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Title
Part B: Glycodynamics: Glucose Disposal
Description
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.
Time Frame
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Title
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
Description
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.
Time Frame
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All Participants
Are healthy males or participants with T1DM
Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
Healthy Participants ONLY
Are overtly healthy, as determined by medical history and physical examination
Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening
Participants with T1DM ONLY
Have a diagnosis of T1DM for at least 1 year based on medical history
Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)
Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
Have had no episodes of severe hypoglycemia in the past 6 months
Exclusion Criteria:
All Participants
Have a hemoglobin level <12.0 grams/deciliter (g/dL)
Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study
Healthy Participants ONLY
• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).
Participants with T1DM ONLY
Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
Require a total daily insulin dose exceeding 100 units (U)
Have fasting triglycerides >400 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
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A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
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