Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Key facts

Study ID

NCT00859898

Run by

AstraZeneca

People needed

1093

Starts

2009-04-01

Expected to finish

2010-05-01

Last updated by the study team

2016-07-07

Who can join

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

You may qualify if…

• Treatment naive males and females, >= 18 years old and
• <= 77 years old, with type 2 diabetes mellitus
• Subjects must have central laboratory pre-randomization hemoglobin A1C >= 7.5 and <= 12.0%
• 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) >3X*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
• Calcium value outside of the central laboratory normal reference range
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
• Urine albumin:creatinine ratio (UACR) >1800 mg/g (203.4 mg/mmol Cr)
• Severe uncontrolled hypertension defined as systolic blood pressure (SBP) >=180 mmHg and/or diastolic blood pressure (DBP) >=110 mmHg
• Hemoglobin >=11.0 g/dL (110 g/L) for men; hemoglobin >=10.0 g/dL (100 g/L) for women
• Positive for hepatitis B surface antigen
• Positive for anti-hepatitis C virus antibody
• History of diabetes insipidus
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Symptoms of poorly controlled diabetes that would preclude participation in this trial

Where it is running

• Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc — Tempe, Arizona, United States
• Clinical Research Advantage, Inc. — Tempe, Arizona, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Encompass Clinical Research-North Coast — Encinitas, California, United States
• Southland Clinical Research Center, Inc. — Fountain Valley, California, United States
• Valley Research — Fresno, California, United States
• Del Rosario Medical Clinic, Inc. — Huntington Park, California, United States
• Irvine Center For Clinical Research, Inc. — Irvine, California, United States
• Pacific Sleep Medicine Services (Avastra Clinical Trials) — Redlands, California, United States
• Orange County Research Center — Tustin, California, United States
• Lynn Institute Of The Rockies — Colorado Springs, Colorado, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Nextphase Clinical Trials, Inc. — Miami, Florida, United States
• Baptist Diabetes Associates — Miami, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Lake Hartwell Family Medicine — Hartwell, Georgia, United States
• Middle Georgia Drug Study Center, Llc — Perry, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Provident Clinical Research — Addison, Illinois, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Deerbrook Medical Associates — Vernon Hills, Illinois, United States
• Physicians Research Group — Indianapolis, Indiana, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• International Institute Of Clinical Research — Ozark, Alabama, United States

Full record on ClinicalTrials.gov

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