A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Healthy Volunteers

Treatments: Other: Insulin glargine; Drug: LY2605541

Study type: Interventional

Funder types: Industry

Identifiers

NCT01654380

12157

I2R-MC-BIAV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 6 patient groups

Part A, Cohort A; LY2605541

Experimental group

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

Treatment:

Drug: LY2605541

Part A, Cohort A; Insulin Glargine

Active Comparator group

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

Treatment:

Other: Insulin glargine

Part A, Cohort B; LY2605541

Experimental group

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.

Treatment:

Drug: LY2605541

Part A, Cohort B; Insulin Glargine

Active Comparator group

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.

Treatment:

Other: Insulin glargine

Part B; LY2605541

Experimental group

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.

Treatment:

Drug: LY2605541

Part B; Insulin Glargine

Active Comparator group

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.

Treatment:

Other: Insulin glargine