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

PHASE3CompletedINTERVENTIONAL
Enrollment

915

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

May 31, 2010

Conditions
Type 2 Diabetes
Interventions
DRUG

Dapagliflozin

Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

DRUG

Placebo

Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

DRUG

Metformin

Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Trial Locations (75)

1034

Local Institution, Capital Federal

1429

Local Institution, Capital Federal

1431

Local Institution, Buenos Aires

2800

Local Institution, Zárate

5000

Local Institution, Córdoba

5152

Local Institution, Villa Carlos Paz

7600

Local Institution, Mar del Plata

11800

Local Institution, Df

15216

Banksville Medical Pc, Pittsburgh

17013

Cumberland Valley Endocrinology Center, Llc, Carlisle

17519

Local Institution, Marília

20211

Local Institution, Rio de Janeiro

28557

Diabetes & Endocrinology Consultants, Pc, Morehead City

29485

Palmetto Clinical Research, Summerville

29687

Southeastern Research Assoc, Taylors

32428

Family Care Associates Of Nw Florida, Chipley

32701

Central Florida Clinical Trials, Inc., Altamonte Springs

37502

Local Institution, Itajubá

43055

Newark Physician Associates, Newark

44650

Local Institution, Guadalajara

44670

Local Institution, Guadalajara

Local Institution, Guadalajara

45150

Local Institution, Zapopan

56440

Health Partners Research Foundation, Minneapolis

60021

Local Institution, Fortaleza

63017

Woodlake Research, Chesterfield

64460

Local Institution, Monterrey

64700

Local Institution, Monterrrey

64710

Local Institution, Durango

Local Institution, Monterrey

66073

Local Institution, Belém

73159

Integris Family Care S. Penn, Oklahoma City

77081

Texas Center For Drug Development, P.A., Houston

78229

Diabetes & Glandular Disease Research Associates, Inc., San Antonio

S.A.M. Clinical Research Center, San Antonio

80209

Denver Internal Medicine, Denver

80401

New West Physicians, Golden

80909

Express Care Clinical Res, Colorado Springs

84102

Optimum Clinical Research, Salt Lake City

85282

Clinical Research Advantage / Desert Clinical Res, Llc, Tempe

89101

Nevada Alliance Against Diabetes, Las Vegas

89109

Local Institution, Tampico

90023

Randall Shue, D.O., Los Angeles

90035

Local Institution, Porto Alegre

90505

Raikhel, Marina, Torrance

91325

Diabetes Medical Center Of California, Northridge

91436

Medical Group Of Encino, Encino

91978

Encompass Clinical Research, Spring Valley

92117

Ritchken & First M.D.'S, San Diego

93720

Valley Research, Fresno

95070

Local Institution, Caxias do Sul

99216

Office Of Dr. Gray, Spokane

90020090

Local Institution, Porto Alegre

C1056ABJ

Local Institution, Capital Federal

C1425AGC

Local Institution, Capital Federal

C1505CWB

Local Institution, Ciudad Auton.

C1408INH

Local Institution, Ciudad Auton

T2R 0X7

Local Institution, Calgary

V1Y 2H4

Local Institution, Kelowna

R3E 3P4

Local Institution, Winnipeg

E2A 4X7

Local Institution, Bathurst

A1N 1W7

Local Institution, Mount Pearl

A1E 2E2

Local Institution, St. John's

N7T 4X3

Local Institution, Sarnia

L4J 8L7

Local Institution, Thornhill

M4R 2G4

Local Institution, Toronto

M9W 4L6

Local Institution, Toronto

C1A 5Y9

Local Institution, Charlottetown

J2B 7T1

Local Institution, Drummondville

J2G 8Z9

Local Institution, Granby

G2E 2X1

Local Institution, L'Ancienne-Lorette

J7J 2K8

Local Institution, Mirabel

H1S 3A9

Local Institution, Saint-Léonard

S7K 3H3

Local Institution, Saskatoon

S7K 7H9

Local Institution, Saskatoon

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AstraZeneca

INDUSTRY