- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654380
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Diego, California, United States
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A, Cohort A; 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.
All periods were separated by a minimum 6-day washout period
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LY2605541 is a solution.
The concentration of LY2605541 is 100 units/milliliter (U/mL).
|
Active Comparator: Part A, Cohort A; Insulin Glargine
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
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Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
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Experimental: Part A, Cohort B; 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.
All periods were separated by a minimum 6-day washout period.
|
LY2605541 is a solution.
The concentration of LY2605541 is 100 units/milliliter (U/mL).
|
Active Comparator: Part A, Cohort B; Insulin Glargine
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.
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Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
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Experimental: Part B; LY2605541
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.
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LY2605541 is a solution.
The concentration of LY2605541 is 100 units/milliliter (U/mL).
|
Active Comparator: Part B; Insulin Glargine
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.
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Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part B: Glucodynamics: Endogenous Glucose Output
Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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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. |
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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Part B: Glycodynamics: Glucose Disposal
Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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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. |
Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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Part B: Glycodynamics: Maximum Rate of Glucose Disposal
Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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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.
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Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12157
- I2R-MC-BIAV (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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