NCT01658501

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

Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 593 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	50 mg PB1023
DRUG	70 mg PB1023
DRUG	100 mg PB1023
DRUG	Placebo (0.9% Sodium Chloride)
DRUG	Victoza®
OTHER	Diet and Exercise
DRUG	Metformin
DRUG	Sulfonylurea
DRUG	Metformin and Sulfonylurea

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-08-07
• Last updated: 2015-12-07

Locations

93 sites across 1 country: United States