Status:
COMPLETED
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With 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 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 ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2009
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT00736879
Start Date
September 22 2008
End Date
December 29 2009
Last Update
April 20 2017
Active Locations (62)
Enter a location and click search to find clinical trials sorted by distance.
1
Dedicated Clinical Research
Litchfield Park, Arizona, United States, 85340
2
43rd Medical Associates, P.C.
Phoenix, Arizona, United States, 85051
3
Clinical Research Advantage, Inc.
Tempe, Arizona, United States, 85282
4
Valley Research
Fresno, California, United States, 93720