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NCT00717457 · ClinicalTrials.gov registry record · Phase 3
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,189
- Enrollment target
NCT00717457 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,189 participants.
The verdict
NCT00717457, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,189 participants
- Enrollment target
Study Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.
Interventions
- DRUG exenatide
- DRUG taspoglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,189 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00717457
The ClinicalTrials.gov registry entry for NCT00717457 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,189 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which exenatide is the first listed.
NCT00717457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00717457 about?
NCT00717457 is a clinical study titled "A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.". This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once week...
What is the current status of trial NCT00717457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,189 participants. The study started on 2008-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00717457?
The interventions under investigation include: exenatide (DRUG), taspoglutide (DRUG).
Who is sponsoring clinical trial NCT00717457?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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