NCT02119819

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

Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	LY2944876	Administered SC
DRUG	Exenatide extended-release	Administered SC
DRUG	Placebo	Administered SC
DRUG	Metformin	Oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2014-04-22
• Last updated: 2021-05-27
• Results posted: 2021-04-14

Locations

51 sites across 6 countries: United States, Greece, Mexico, Poland, Puerto Rico, Romania