Conditions: Healthy Volunteers Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: 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 2: 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 3: 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 4: 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 5: 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 6: 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.

Interventions: intervention 1: LY2605541 intervention 2: Insulin glargine
Intervention descriptions: intervention 1: LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL). intervention 2: Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Protocol document: