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

Westside Center for Clinical Research

Jacksonville, Florida 32205

from

Jacksonville, FL