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NCT00658021 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT00658021: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00658021 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658021, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU
Primary Outcome
Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Interventions
- DRUG Placebo
- DRUG Exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2008-05-30 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 3 |
What the finished NCT00658021 record still lists
NCT00658021 is an interventional study that assigns participants to a tested intervention. The registered 122 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 (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00658021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658021 about?
NCT00658021 is a clinical study titled "Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes". The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antid...
What is the current status of trial NCT00658021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2008-05-30. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT00658021?
The interventions under investigation include: Placebo (DRUG), Exenatide (DRUG).
Who is sponsoring clinical trial NCT00658021?
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 NCT00658021's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 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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