Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

• Status: Completed
• Trial end date: 2013-07-01

Summary

Primary objective:

The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.

Secondary objectives:

The secondary objectives are to:

• Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;

• Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;

• Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;

• Describe the frequencies of adverse events in the treatment groups; and

• Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.

• Phase: Phase 2

Details

• Lead Sponsor: PhaseBio Pharmaceuticals Inc.
• Treatments: Liraglutide; Metformin