Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 464 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02229383
The ClinicalTrials.gov registry entry for NCT02229383 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Exenatide is the first listed.
NCT02229383 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.