drugset / Trial / NCT01688635

A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

NCT01688635

Phase 1 Completed 91 enrolled Eli Lilly and Company
RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2012-09
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject LY2963016 Protein / enzyme biologic 0.5 iu/kg Subcutaneous
Subject insulin glargine Protein / enzyme biologic 0.5 iu/kg Subcutaneous

Indications

No indication recorded.