drugset / Trial / NCT02119819

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

NCT02119819

Phase 2 Completed 420 enrolled OPKO Health, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Timeline

Start
2014-04
Primary completion
2015-08
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Exenatide Peptide 2 mg Subcutaneous
Subject PEGAPAMODUTIDE Protein / enzyme biologic 10 mg Subcutaneous
Subject PEGAPAMODUTIDE Protein / enzyme biologic 15 mg Subcutaneous
Subject PEGAPAMODUTIDE Protein / enzyme biologic 30 mg Subcutaneous
Subject PEGAPAMODUTIDE Protein / enzyme biologic 50 mg Subcutaneous
Background Metformin Small molecule Oral