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NCT01658501 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Type 2 Diabetes Mellitus, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 593
- Enrollment target
- 20
- Study locations
NCT01658501 is a Phase 2 study of Type 2 Diabetes Mellitus that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 593 participants, below the 2,744-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT01658501, a Phase 2 study of Type 2 Diabetes Mellitus, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 593 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG 50 mg PB1023
- DRUG 70 mg PB1023
- DRUG 100 mg PB1023
- DRUG Placebo (0.9% Sodium Chloride)
- DRUG Victoza®
Study Locations (20)
California
- - Chula Vista
- - Concord
- - Escondido
- - Hawaiian Gardens
- - La Mesa
- - Los Angeles
- - Oceanside
Alabama
- - Anniston
- - Birmingham
- - Gulf Shores
- - Huntsville
- - Mobile
- - Muscle Shoals
Arizona
- - Chandler
- - Glendale
- - Goodyear
- - Tucson
Arkansas
- - Harrisburg
- - Little Rock
- - Searcy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 593 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01658501
The ClinicalTrials.gov registry entry for NCT01658501 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 593 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,744-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (78% lower). The listed sponsor is PhaseBio Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which 50 mg PB1023 is the first listed.
NCT01658501 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01658501 about?
NCT01658501 is a clinical study titled "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". 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 ...
What is the current status of trial NCT01658501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 593 participants. The study started on 2012-07. Estimated completion is 2013-07.
What conditions does trial NCT01658501 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01658501?
The interventions under investigation include: 50 mg PB1023 (DRUG), 70 mg PB1023 (DRUG), 100 mg PB1023 (DRUG), Placebo (0.9% Sodium Chloride) (DRUG), Victoza® (DRUG).
Who is sponsoring clinical trial NCT01658501?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01658501 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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