Conditions: Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: no

Brief summary:
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Detailed description:

Arms:
arm 1: A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. arm 2: A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.

Interventions: intervention 1: LY2963016 intervention 2: Lantus
Intervention descriptions: intervention 1: Single 0.3 U/kg dose administered subcutaneously intervention 2: Single 0.3 U/kg dose administered subcutaneously

Protocol document: