An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Completed · Phase 3
Conditions studied: Type 2 Diabetes
In brief
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
Key facts
- Study ID
- NCT00643851
- Run by
- AstraZeneca
- People needed
- 994
- Starts
- 2008-06-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2023-01-30
Who can join
Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m
- Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women
You may not qualify if…
- AST and/or ALT >3.0 times the upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL
- Creatine kinase > 3X the upper limit of normal (ULN)
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Where it is running
- Winston Technology Research, Llc — Haleyville, Alabama, United States
- Clinical Research Advantage, Inc. — Tempe, Arizona, United States
- John Muir Physician Network Clinical Research Center — Concord, California, United States
- Southland Clinical Research Center, Inc. — Fountain Valley, California, United States
- Valley Research — Fresno, California, United States
- Central Florida Clinical Trials, Inc. — Altamonte Springs, Florida, United States
- Clinical Therapeutics Corporation — Coral Gables, Florida, United States
- Florida Research Network, Llc — Gainesville, Florida, United States
- Fpa Clinical Research — Kissimmee, Florida, United States
- Nextphase Clinical Trials, Inc. — Miami, Florida, United States
- Middle Georgia Drug Study Center, Llc — Perry, Georgia, United States
- Cedar Crosse Research Center — Chicago, Illinois, United States
- Deerbrook Medical Associates — Vernon Hills, Illinois, United States
- Jackson Clinic — Rolling Fork, Mississippi, United States
- Mercy Medical Group/Dba Woodlake Research — Chesterfield, Missouri, United States
- Hudson Valley Clinical Research Center — Kingston, New York, United States
- Metrolina Medical Research — Charlotte, North Carolina, United States
- Crescent Medical Research — Salisbury, North Carolina, United States
- Community Health Care, Inc. — Canal Fulton, Ohio, United States
- Wells Institute For Health Awareness — Kettering, Ohio, United States
- Newark Physician Associates — Newark, Ohio, United States
- Physician Research, Inc. — Zanesville, Ohio, United States
- Gilbert Medical Research, Llc — Bethany, Oklahoma, United States
- Integris Family Care South Penn — Oklahoma City, Oklahoma, United States
- Greystone Medical Research, Llc — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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