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

Registration

Registration

NCT01658501

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

593

Start

2012-07

Primary completion

2013-07

Lead sponsor

PhaseBio Pharmaceuticals Inc.

Conditions

Type 2 Diabetes Mellitus

Interventions

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

Results posted

FALSE

Registered primary outcomes

• Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator [Baseline and 20 weeks]