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

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 77
Updated:	4/21/2016
Start Date:	September 2008
End Date:	December 2009

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

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

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Capital Clinical Research Center

Olympia, Washington 98502

from

Olympia, WA