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NCT03353350 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Hanmi Pharmaceutical Company Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT03353350: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Hanmi Pharmaceutical Company Limited.
NCT03353350 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 406 participants, below the 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03353350, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by Hanmi Pharmaceutical Company Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight * To evaluate the safety of once-weekly injection of efpeglenatide
Primary Outcome
Change from Baseline to Week 30 in HbA1c
Conditions Studied
Interventions
- DRUG placebo
- DRUG efpeglenatide (SAR439977)
Study Locations (20)
California
- Investigational Site Number 8400003 - Canoga Park
- Investigational Site Number 8400007 - Chula Vista
- Investigational Site Number 8400011 - La Mesa
- Investigational Site Number 8400009 - Los Angeles
- Investigational Site Number 8400029 - Pomona
- Investigational Site Number 8400024 - Tarzana
- Investigational Site Number 8400026 - Van Nuys
Florida
- Investigational Site Number 8400010 - DeLand
- Investigational Site Number 8400006 - Hialeah
- Investigational Site Number 8400032 - West Palm Beach
Nevada
- Investigational Site Number 8400062 - Las Vegas
- Investigational Site Number 8400021 - Las Vegas
Alabama
- Investigational Site Number 8400004 - Birmingham
Arizona
- Investigational Site Number 8400005 - Glendale
Georgia
- Investigational Site Number 8400025 - Lawrenceville
Illinois
- Investigational Site Number 8400034 - Chicago
Missouri
- Investigational Site Number 8400033 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2017-12-05 |
| Est. Completion | 2020-09-07 |
| Phase | Phase 3 |
What the finished NCT03353350 record still lists
NCT03353350 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT03353350 names 20 study sites across 11 states, led by California, Florida, Nevada.
Frequently Asked Questions
What is clinical trial NCT03353350 about?
NCT03353350 is a clinical study titled "Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise". Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate th...
What is the current status of trial NCT03353350?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2017-12-05. Estimated completion is 2020-09-07.
What conditions does trial NCT03353350 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT03353350?
The interventions under investigation include: placebo (DRUG), efpeglenatide (SAR439977) (DRUG).
Who is sponsoring clinical trial NCT03353350?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03353350 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03353350's enrollment target sits among peer trials
406 22nd of 130 higher than 109 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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