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NCT02229396 · ClinicalTrials.gov registry record · Phase 3
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
A Phase 3 study of Diabetes Mellitus, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 695
- Enrollment target
- 20
- Study locations
NCT02229396: Completed Phase 3 study of Diabetes Mellitus, sponsored by AstraZeneca.
NCT02229396 is a Phase 3 study of Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 695 participants, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229396, a Phase 3 study of Diabetes Mellitus, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 695 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Primary Outcome
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Conditions Studied
Interventions
- DRUG Dapagliflozin
- DRUG Exantide with Dapagliflozin
- DRUG Exentide
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Chula Vista
- Research Site - El Cajon
- Research Site - Fresno
- Research Site - La Mesa
- Research Site - Long Beach
- Research Site - Los Angeles
- Research Site - Mission Hills
- Research Site - Montclair
- Research Site - Oceanside
- Research Site - San Diego
- Research Site - San Diego
- Research Site - Tustin
- Research Site - Van Nuys
Alabama
- Research Site - Birmingham
- Research Site - Huntsville
- Research Site - Tuscumbia
Arizona
- Research Site - Glendale
- Research Site - Tempe
Florida
- Research Site - Boynton Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 695 participants |
| Start Date | 2014-09-04 |
| Est. Completion | 2017-12-28 |
| Phase | Phase 3 |
What the finished NCT02229396 record still lists
NCT02229396 is an interventional study that assigns participants to a tested intervention. The registered 695 participants enrollment target is mid-sized for trials with a published cap, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Dapagliflozin is the first listed.
NCT02229396 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02229396 about?
NCT02229396 is a clinical study titled "Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo". Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone a...
What is the current status of trial NCT02229396?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 695 participants. The study started on 2014-09-04. Estimated completion is 2017-12-28.
What conditions does trial NCT02229396 study?
This clinical trial studies the following conditions: Diabetes Mellitus.
What interventions are being tested in trial NCT02229396?
The interventions under investigation include: Dapagliflozin (DRUG), Exantide with Dapagliflozin (DRUG), Exentide (DRUG).
Who is sponsoring clinical trial NCT02229396?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02229396 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
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 NCT02229396's enrollment target sits among peer trials
695 36th of 208 higher than 173 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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