Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Key facts

Study ID

NCT00663260

Run by

AstraZeneca

People needed

631

Starts

2008-06-01

Expected to finish

2011-06-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
• Clinical diagnosis of moderate renal impairment

You may not qualify if…

• AST and /or ALT > 3.0 times the upper limit of normal
• Serum total bilirubin > 1.5 times ULN
• Symptoms of severely uncontrolled diabetes
• Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Where it is running

• Valley Research — Fresno, California, United States
• Marin Endocrine Care & Research, Inc. — Greenbrae, California, United States
• Office Of Richard Cherlin, Md — Los Gatos, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Apex Research Of Riverside — Riverside, California, United States
• La Biomed At Harbor Ucla Med Ctr. — Torrance, California, United States
• Endocrine Associates Of The Rockies — Denver, Colorado, United States
• Panhandle Family Care Associates — Marianna, Florida, United States
• Genesis Clinical Research — Tampa, Florida, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Twin Cities Clinical Research — Brooklyn Center, Minnesota, United States
• Kcva Medical Center Research Svc (151) — Kansas City, Missouri, United States
• Va Nebraska-Western Iowa Health Care System (Nwihcs) — Omaha, Nebraska, United States
• University Of Medicine And Dentistry Of New Jersey — Voorhees Township, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Slocum-Dickson Medical Group, Pllc — New Hartford, New York, United States
• Community Health Care Of Manchester — Akron, Ohio, United States
• Center For Thyroid Diseases And Endocrinology — Beachwood, Ohio, United States
• Physician Research, Inc. — Zanesville, Ohio, United States
• Univ Of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
• Rogue Valley Clinical Research — Medford, Oregon, United States
• Drexel University College Of Medicine — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Low Country Internal Medicine Of Sc, Pa — Charleston, South Carolina, United States
• Vista Medical Research, Inc. — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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