Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

Key facts

Study ID

NCT00736879

Run by

AstraZeneca

People needed

497

Starts

2008-09-22

Expected to finish

2009-12-29

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
• Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
• Body Mass Index ≤ 45 kg/m²
• Must be able to perform self monitoring of blood glucose

You may not qualify if…

• aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
• Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
• Creatinine kinase >3* ULN
• Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Where it is running

• 43rd Medical Associates, P.C. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. — Tempe, Arizona, United States
• Valley Research — Fresno, California, United States
• Marina Raikhel, Md, Faafp — Lomita, California, United States
• Richard S. Cherlin, Md — Los Gatos, California, United States
• Orange County Research Center — Tustin, California, United States
• Family Physicians Of Greeley — Greeley, Colorado, United States
• Coastal Connecticut Research, Llc — New London, Connecticut, United States
• Central Florida Clinical Trials, Inc. — Altamonte Springs, Florida, United States
• Westside Center For Clinical Research — Jacksonville, Florida, United States
• Panhandle Family Care Associates — Marianna, Florida, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Belzoni Clinical Research — Belzoni, Mississippi, United States
• R-Research — Hamilton, New Jersey, United States
• Internist Associates Of Central New York — Syracuse, New York, United States
• Southgate Medical Group — West Seneca, New York, United States
• Down East Medical Associates, Pa — Morehead City, North Carolina, United States
• James J. Brown, Md — Akron, Ohio, United States
• Integris Family Care South — Oklahoma City, Oklahoma, United States
• Southeastern Research Associates, Inc. — Taylors, South Carolina, United States
• Abbott Clinical Research Group, Inc — San Antonio, Texas, United States
• Avastra Clinical Trials — Midvale, Utah, United States
• Optimum Clinical Research, Inc. — Salt Lake City, Utah, United States
• Capital Clinical Research Center — Olympia, Washington, United States
• Dedicated Clinical Research — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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