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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 122 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00658021
The ClinicalTrials.gov registry entry for NCT00658021 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 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 Placebo is the first listed.
NCT00658021 reports 0 study locations.
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.
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