A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

NCT ID: NCT01654380

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Healthy Volunteers; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

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

Group Type: ACTIVE_COMPARATOR

Insulin glargine

Intervention Type: OTHER

Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

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.

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

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.

Group Type: ACTIVE_COMPARATOR

Insulin glargine

Intervention Type: OTHER

Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

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.

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

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.

Group Type: ACTIVE_COMPARATOR

Insulin glargine

Intervention Type: OTHER

Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Interventions

LY2605541

LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

Intervention Type: DRUG

Insulin glargine

Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

San Diego, California, United States

Countries

United States

Other Identifiers

I2R-MC-BIAV

Identifier Type: OTHER

Identifier Source: secondary_id

12157

Identifier Type: -

Identifier Source: org_study_id