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

NCT01658501 · Completed

Last updated 2026-05-28

This clinical trial tests three different doses of a medication called PB1023, given as weekly injections, to see how it affects blood sugar levels in adults with type 2 diabetes over 20 weeks, compared to a placebo and another active treatment.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 593 people

Who can join Ages 18–75 · all sexes

Timeline Started 2012-07 · est. completion 2013-07

Where 93 sites · United States

What this study is testing ClinicalTrials.gov NCT01658501 ↗

Description as written by the study sponsor.

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.

Treatments tested

50 mg PB1023 Drug
70 mg PB1023 Drug
100 mg PB1023 Drug
Placebo (0.9% Sodium Chloride) also known as SC Weekly Injection Drug
Victoza® also known as daily SC injection Drug
Diet and Exercise Other
Metformin Drug
Sulfonylurea Drug
Metformin and Sulfonylurea Drug

Main thing measured	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
Sponsor	PhaseBio Pharmaceuticals Inc.
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01658501 ↗