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NCT00643851 · ClinicalTrials.gov registry record · Phase 3
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
A Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 994
- Enrollment target
- 20
- Study locations
NCT00643851: Completed Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.
NCT00643851 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 994 participants, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00643851, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 994 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied
Primary Outcome
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtai
Conditions Studied
Interventions
- DRUG Dapagliflozin
- DRUG Metformin XR
Study Locations (20)
Florida
- Central Florida Clinical Trials, Inc. - Altamonte Springs
- Clinical Therapeutics Corporation - Coral Gables
- Florida Research Network, Llc - Gainesville
- Fpa Clinical Research - Kissimmee
- Nextphase Clinical Trials, Inc. - Miami
California
- John Muir Physician Network Clinical Research Center - Concord
- Southland Clinical Research Center, Inc. - Fountain Valley
- Valley Research - Fresno
Alabama
- Greystone Medical Research, Llc - Birmingham
- Winston Technology Research, Llc - Haleyville
Illinois
- Cedar Crosse Research Center - Chicago
- Deerbrook Medical Associates - Vernon Hills
North Carolina
- Metrolina Medical Research - Charlotte
- Crescent Medical Research - Salisbury
Arizona
- Clinical Research Advantage, Inc. - Tempe
Georgia
- Middle Georgia Drug Study Center, Llc - Perry
Mississippi
- Jackson Clinic - Rolling Fork
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 994 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00643851 record still lists
NCT00643851 is an interventional study that assigns participants to a tested intervention. The registered 994 participants enrollment target is mid-sized for trials with a published cap, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Dapagliflozin is the first listed.
NCT00643851 names 20 study sites across 11 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT00643851 about?
NCT00643851 is a clinical study titled "An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets". The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatm...
What is the current status of trial NCT00643851?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 994 participants. The study started on 2008-06. Estimated completion is 2009-08.
What conditions does trial NCT00643851 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT00643851?
The interventions under investigation include: Dapagliflozin (DRUG), Metformin XR (DRUG).
Who is sponsoring clinical trial NCT00643851?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00643851 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00643851's enrollment target sits among peer trials
994 27th of 327 higher than 301 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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