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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,484

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Type 2 Diabetes
Interventions
DRUG

Dapagliflozin

Tablets, Oral, 5 mg, Once daily, 24 weeks

DRUG

Dapagliflozin

Tablets, Oral, 10 mg, Once daily, 24 weeks

DRUG

Metformin

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

DRUG

Dapagliflozin Placebo

Tablets, Oral, 0 mg, Once daily, 24 weeks

DRUG

Pioglitazone

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Trial Locations (33)

100001

Local Institution, Beijing

100029

Local Institution, Beijing

100044

Local Institution, Beijing

100700

Local Institution, Beijing

100730

Local Institution, Beijing

110003

Local Institution, Shenyang

130041

Local Institution, Changchun

150001

Local Institution, Haerbin

200003

Local Institution, Shanghai

200040

Local Institution, Shanghai

200065

Local Institution, Shanghai

210006

Local Institution, Nanjing

210008

Local Institution, Nanjing

214023

Local Institution, Wuxi

230022

Local Institution, Hefei

300211

Local Institution, Tianjin

302023

Local Institution, Jaipur

310009

Local Institution, Hangzhou

400010

Local Institution, Chongqing

400016

Local Institution, Chongqing

410000

Local Institution, Changsha

410008

Local Institution, Changsha

452010

Local Institution, Indore

510120

Local Institution, Guangzhou

560092

Local Institution, Bangalore

610070

Local Institution, Chengdu

632004

Local Institution, Vellore, Tamilnadu

710032

Local Institution, Xi'an

560 043

Local Institution, Bangalore

139-711

Local Institution, Seoul

614-735

Local Institution, Busan

120-752

Local Institution, Seoul

137-040

Local Institution, Seoul

Sponsors
All Listed Sponsors
collaborator

AstraZeneca, Bristol-Myers Squibb

UNKNOWN

lead

AstraZeneca

INDUSTRY