A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 77
Updated:	4/21/2016
Start Date:	September 2007
End Date:	May 2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help
reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled
on metformin alone. The safety of this treatment will also be studied.

Key Inclusion Criteria

- Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic
control

- Participants who have been receiving metformin at a total daily dose ≥1500 mg per day
for at least 8 weeks

- C-peptide ≥1.0 ng/mL

- Body mass index ≤45.0 kg/m^2

- Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

- Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper
limit of normal

- Serum total bilirubin level >2 mg/dL

- Creatinine kinase level >3 times upper limit of normal

- Symptoms of severely uncontrolled diabetes

- Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women

- Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic,
endocrine, psychiatric, or rheumatic diseases

We found this trial at

sites

Cumberland Valley Endocrinology Center, Llc

Carlisle, Pennsylvania 17013

from

Carlisle, PA