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NCT00823992 · ClinicalTrials.gov registry record · Phase 3
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT00823992 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 305 participants.
The verdict
NCT00823992, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG placebo
- DRUG taspoglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00823992
The ClinicalTrials.gov registry entry for NCT00823992 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 305 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 placebo is the first listed.
NCT00823992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00823992 about?
NCT00823992 is a clinical study titled "A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy". This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by ...
What is the current status of trial NCT00823992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2009-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00823992?
The interventions under investigation include: placebo (DRUG), taspoglutide (DRUG).
Who is sponsoring clinical trial NCT00823992?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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