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NCT00755287 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,072
- Enrollment target
NCT00755287 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,072 participants.
The verdict
NCT00755287, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,072 participants
- Enrollment target
Study Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.
Interventions
- DRUG metformin
- DRUG insulin glargine
- DRUG taspoglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,072 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00755287
The ClinicalTrials.gov registry entry for NCT00755287 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,072 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 3 interventions - of which metformin is the first listed.
NCT00755287 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00755287 about?
NCT00755287 is a clinical study titled "A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.". This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (1...
What is the current status of trial NCT00755287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,072 participants. The study started on 2008-11. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00755287?
The interventions under investigation include: metformin (DRUG), insulin glargine (DRUG), taspoglutide (DRUG).
Who is sponsoring clinical trial NCT00755287?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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