Conditions: Healthy
Keywords: Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 91
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Detailed description:

Arms:
arm 1: Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study arm 2: Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study

Interventions: intervention 1: LY2963016 intervention 2: US Approved Lantus
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol document: