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NCT02229383 · ClinicalTrials.gov registry record · Phase 3
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 464
- Enrollment target
NCT02229383: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02229383 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 464 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229383, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 464 participants
- Enrollment target
Study Summary
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
Primary Outcome
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
Interventions
- DRUG Exenatide
- DRUG Exenatide matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2014-09-06 |
| Est. Completion | 2016-08-29 |
| Phase | Phase 3 |
What the finished NCT02229383 record still lists
NCT02229383 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Exenatide is the first listed.
NCT02229383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02229383 about?
NCT02229383 is a clinical study titled "Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus". Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine wit...
What is the current status of trial NCT02229383?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2014-09-06. Estimated completion is 2016-08-29.
What interventions are being tested in trial NCT02229383?
The interventions under investigation include: Exenatide (DRUG), Exenatide matching placebo (DRUG).
Who is sponsoring clinical trial NCT02229383?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02229383's enrollment target sits among peer trials
464 821st of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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