drugset / Trial / NCT01600950

A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

NCT01600950

Phase 1 Completed 20 enrolled Eli Lilly and Company
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2012-05
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject LY2963016 Protein / enzyme biologic 0.3 iu/kg Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.3 iu/kg Subcutaneous