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NCT00754988 · ClinicalTrials.gov registry record · Phase 3
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 666
- Enrollment target
- 20
- Study locations
NCT00754988 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 666 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00754988, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 666 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Sitagliptin
- DRUG Placebo (matching sitagliptin)
- DRUG Placebo (matching taspoglutide)
- DRUG Taspoglutide
Study Locations (20)
California
- - Huntington Beach
- - La Jolla
- - Los Angeles
- - Roseville
- - San Francisco
- - Tacoma
Florida
- - Daytona Beach
- - Hialeah
- - Jacksonville
- - Miami
- - Panama City
- - Tampa
Alabama
- - Birmingham
- - Huntsville
- - Tallassee
Arizona
- - Scottsdale
Arkansas
- - Little Rock
Colorado
- - Colorado Springs
Connecticut
- - New London
District of Columbia
- - Manati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00754988
The ClinicalTrials.gov registry entry for NCT00754988 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (85% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 5 interventions - of which Metformin is the first listed.
NCT00754988 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00754988 about?
NCT00754988 is a clinical study titled "A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.". This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 wee...
What is the current status of trial NCT00754988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2008-10. Estimated completion is 2011-03.
What conditions does trial NCT00754988 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00754988?
The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Placebo (matching sitagliptin) (DRUG), Placebo (matching taspoglutide) (DRUG), Taspoglutide (DRUG).
Who is sponsoring clinical trial NCT00754988?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00754988 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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