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Completed Phase 3 Interventional Results available

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

ClinicalTrials.gov ID: NCT00643851

Public ClinicalTrials.gov record NCT00643851. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 4, 2026, 10:13 PM EST

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Official title

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00643851
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
994 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 77 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2008 (Type not available)
Primary completion
Aug 2009 (Actual)
Completion
Aug 2009 (Actual)
Last update posted
Jan 30, 2023

2008 – 2009

United States locations

U.S. sites
44
U.S. states
18
U.S. cities
39
Facility City State ZIP Site status
Greystone Medical Research, Llc Birmingham Alabama 35242 —
Winston Technology Research, Llc Haleyville Alabama 35565 —
Clinical Research Advantage, Inc. Tempe Arizona 85282 —
John Muir Physician Network Clinical Research Center Concord California 94520 —
Southland Clinical Research Center, Inc. Fountain Valley California 92708 —
Valley Research Fresno California 93720 —
Central Florida Clinical Trials, Inc. Altamonte Springs Florida 32701 —
Clinical Therapeutics Corporation Coral Gables Florida 33134 —
Florida Research Network, Llc Gainesville Florida 32605 —
Fpa Clinical Research Kissimmee Florida 34741 —
Nextphase Clinical Trials, Inc. Miami Florida 33145 —
Middle Georgia Drug Study Center, Llc Perry Georgia 31069 —
Cedar Crosse Research Center Chicago Illinois 60607 —
Deerbrook Medical Associates Vernon Hills Illinois 60061 —
Jackson Clinic Rolling Fork Mississippi 39159 —
Mercy Medical Group/Dba Woodlake Research Chesterfield Missouri 63017 —
Hudson Valley Clinical Research Center Kingston New York 12401 —
Metrolina Medical Research Charlotte North Carolina 28209 —
Crescent Medical Research Salisbury North Carolina 28144 —
Community Health Care, Inc. Canal Fulton Ohio 44614 —
Wells Institute For Health Awareness Kettering Ohio 45429 —
Newark Physician Associates Newark Ohio 43055 —
Physician Research, Inc. Zanesville Ohio 43701 —
Gilbert Medical Research, Llc Bethany Oklahoma 73008 —
Integris Family Care South Penn Oklahoma City Oklahoma 73159 —
Integris Family Care Yukon Yukon Oklahoma 73099 —
Willamette Valley Clinical Studies Eugene Oregon 97404 —
Commonwealth Primary Care, Pc / Fleetwood Clinical Research Fleetwood Pennsylvania 19522 —
Biomedical Research Associates, Llc Shippensburg Pennsylvania 17257 —
Safe Harbor Clinical Research East Providence Rhode Island 02914 —
Southeastern Research Associates, Inc. Greenville South Carolina 29605 —
Spartanburg Medical Research Spartanburg South Carolina 29303 —
Middle Tennessee Clinical Research Fayetteville Tennessee 37334 —
Holston Medical Group Kingsport Tennessee 37660 —
Endocrine Associates Houston Texas 77004 —
Village Family Practice Houston Texas 77024 —
Non-Invasive Cardiovascular, Pa Houston Texas 77074 —
Excel Clinical Research, Llc Houston Texas 77081 —
Texas Center For Drug Development Houston Texas 77081 —
Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw Midland Texas 79705 —
Hill Country Medical Associates New Braunfels Texas 78130 —
Southwest Clinical Research Center, Llc Pearland Texas 77584 —
Covenant Clinical Research, Pa San Antonio Texas 78229 —
S.A.M. Clinical Research Center San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00643851, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 30, 2023 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00643851 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →