A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone. The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Phase 3

Completed

Conditions: Type 2 Diabetes

Registration Number: CTRI/2010/091/000430

Lead Sponsor: The pharmaceutical company sponsoring this study is BristolMyers SquibbAddress

Brief Summary: First subject of the study was screened at Chinese site on 17th June 2010. First subject from India is expected by 15th November 2010. There are approximately 50 subjects to be randomized from India.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 444

Inclusion Criteria

Males and females, 18 to 65 years old, with type 2 diabetes and with inadequate glycemic control.
Drug naive or treated with anti-diabetic medication for < 24 weeks.
C-peptide ≥ 1.0 ng/mL.
Body Mass Index ≤ 45.0 kg/mÂ².

Exclusion Criteria

AST and/or ALT > 1.5 times ULN- Serum total bilirubin > 2 mg/dL- Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women- Creatine kinase ≥ 3 times ULN- Symptoms of severely uncontrolled diabetes-Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c for each dose of dapagliflozin vs placebo	At week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Fasting Plasma Glucose (FPG)	At week 24
Change from baseline in 2hr-post meal glucose	At week 24
Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%	At week 24
Change from baseline in total body weight	At week 24

Trial Locations

Locations (5): D Clinarch,
🇮🇳
Jaipur, RAJASTHAN, India
Department of Endocrinology/Metabolism
🇮🇳
Vellore, TAMIL NADU, India
Life care Clinic & research centre,
🇮🇳
rd.,Sahkar, India
Medisys Clinisearch India Private Limited,
🇮🇳
Kalyan, India
TOTALL Diabetes Hormone Institute
🇮🇳
Indore, MADHYA PRADESH, India
D Clinarch,
🇮🇳Jaipur, RAJASTHAN, India
Dr. Rakesh Parikh
Principal investigator
drrakeshparikh@gmail.com