Status:
COMPLETED
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1093 Patients enrolled
Trial Details
Trial ID
NCT00859898
Start Date
April 1 2009
End Date
May 1 2010
Last Update
July 7 2016
Active Locations (123)
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1
International Institute Of Clinical Research
Ozark, Alabama, United States, 36360
2
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, United States, 85282
3
Clinical Research Advantage, Inc.
Tempe, Arizona, United States, 85282
4
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520