NCT00327015View on ClinicalTrials.gov

A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

PHASE3CompletedINTERVENTIONAL
Enrollment

1,306

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

November 30, 2007

Study Completion Date

December 31, 2008

Conditions
Diabetes
Interventions
DRUG

Saxagliptin

Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)

DRUG

Metformin

Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)

DRUG

Placebo

Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)

DRUG

pioglitazone

Tablets, Oral, 15-45 mg, as needed (12 months LT)

Trial Locations (211)

1000

Local Institution, Manila

1100

Local Institution, Quezon City

1121

Local Institution, Buenos Aires

1221

Local Institution, Capital Federal

1605

Local Institution, Pasig

1800

Local Institution, Marikina City

1824

Local Institution, Lanus Este

2030

Local Institution, Érd

2800

Local Institution, Zárate

3300

Local Institution, Eger

4050

Local Institution, Kyiv

4406

Local Institution, Salta

5000

Local Institution, Iloilo City

5400

Local Institution, San Juan

5700

Local Institution, Gyula

6000

Local Institution, Cebu City

6600

Local Institution, Szentes

6740

Local Institution, Chacabuco

7900

Local Institution, Szigetvár

11992

Local Institution, Moscow

13059

Local Institution, Campinas

15401

Preferred Primary Care Physicians, Uniontown

16132

Local Institution, Genova

17519

Local Institution, Marília

20099

Local Institution, Catania

20132

Local Institution, Milan

20230

Local Institution, Aguascalientes

20232

Local Institution, Aguascalientes

22044

Seven Corners Medical Research Center, Falls Church

24153

Salem Va Medical Ctr Research & Devlopment, Salem

27704

Durham Internal Medicine Assoc., Durham

28209

Metrolina Medical Research, Charlotte

28557

Down East Medical Associates, Morehead City

29651

Internal Medicine Of Greer, Greer

31069

Middle Georgia Drug Study Center, Llc, Perry

32446

Emerald Coast Research Group, Marianna

32605

Florida Research Network, Llc, Gainesville

33134

Clinical Therapeutics Corporation, Coral Gables

33156

Baptist Diabetes Associates, Miami

34246

Local Institution, Vellmar

34741

Fpa Clinical Research, Kissimmee

37334

Middle Tennessee Clinical Research, Fayetteville

37431

Local Institution, Bad

38103

Frontier Clinical Research, Llc., Memphis

39112

Local Institution, Magdeburg

43024

Local Institution, Lutsk

43055

Newark Physician Associates, Newark

44060

Your Diabetes Endocrine Nutrition Group, Mentor

44340

Local Institution, Guadalajara

44646

Massillon Family Practice, Massillon

44650

Local Institution, Guadalajara

44670

Local Institution, Guadalajara

45030

Local Institution, Guadalajara

45200

Local Institution, Guadalajara

45305

Midwest Regional Research, Inc., Bellbrook

46001

Local Institution, Ternopil

46250

Physicians Research Group, Indianapolis

47051

Local Institution, Duisburg

48100

Local Institution, Ravenna

49044

Local Institution, Dniepropetrovsk

52051

Local Institution, Recife

55116

Local Institution, Mainz

60021

Local Institution, Fortaleza

60061

Deerbrook Medical Associates, Vernon Hills

60430

Local Institution, Fortaleza

60607

Cedar Crosse Research Center, Chicago

60617

Adviso Medical Research, Llc, Chicago

61039

Local Institution, Kharkiv

61176

Local Institution, Kharkiv

62250

Local Institution, Cuernavaca

63739

Local Institution, Aschaffenburg

64020

Local Institution, Monterrey

64024

Medical Arts Research Collaborative, Llc, Excelsior Springs

64460

Local Institution, Monterrey

64570

Local Institution, Monterrey

65025

Local Institution, Odesa

66073

Local Institution, Belém

66119

Local Institution, Saarbrücken

66260

Local Institution, Garza García

67073

Local Institution, Ludwigshafen

67203

Professional Network Research Of Kansas, Wichita

68161

Local Institution, Mannheim

69120

Local Institution, Heidelberg

74110

Local Institution, Goiânia

75039

Tiena Health Research, Irving

77004

Endocrine Associates, Houston

77030

Advances In Health,Inc, Houston

77036

Juno Research, Llc, Houston

77074

Non Invasive Cardiovascular Pa, Houston

77471

Med-Cure Primary Care Physicians, Rosenberg

77584

Pearland Primary Care Associates, Llp, Pearland

78130

Hill Country Medical Associates, New Braunfels

78213

Gsa Research, San Antonio

78229

Covenant Clinical Research, Pa, San Antonio

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

78705

Capital Medical Clinic, Llp, Austin

79013

Local Institution, Lviv

79705

Diabetes Center Of The Southwest, Midland

88239

Local Institution, Wangen

89030

Nevada Alliance Against Diabetes, North Las Vegas

90035

Local Institution, Porto Alegre

90404

Coastal Biomedical Research Inc, Santa Monica

91978

Encompass Clinical Research, Spring Valley

92024

Encompass Clinical Research, Encinitas

92868

Community Clinical Trials, Orange

94520

East Bay Clinical Trial Center, Concord

94550

Local Institution, Künzing

95204

St. Joseph'S Medical Associates, Stockton

97070

Local Institution, Mérida

99204

Physicians Clinic Of Spokane, Spokane

105229

Local Institution, Moscow

110076

Local Institution, Sarita Vihar

115093

Local Institution, Moscow

115280

Local Institution, Moscow

117292

Local Institution, Moscow

117593

Local Institution, Moscow

119034

Local Institution, Moscow

123056

Local Institution, Moscow

123423

Local Institution, Moscow

125299

Local Institution, Moscow

125315

Local Institution, Moscow

127486

Local Institution, Moscow

127644

Local Institution, Moscow

129010

Local Institution, Moscow

129119

Local Institution, Moscow

129327

Local Institution, Moscow

132001

Local Institution, Haryāna

150003

Local Institution, Yaroslaval

Local Institution, Yaroslavl

191119

Local Institution, Saint Petersburg

192177

Local Institution, Saint Petersburg

193015

Local Institution, Saint Petersburg

193312

Local Institution, Saint Petersburg

194354

Local Institution, Saint Petersburg

195112

Local Institution, Saint Petersburg

195176

Local Institution, Saint Petersburg

195257

Local Institution, Saint Peterburg

197022

Local Institution, Saint Petersburg

197198

Local Institution, Saint Petersburg

198013

Local Institution, Saint Petersburg

214018

Local Institution, Smolensk

302001

Local Institution, Rajasthan

305035

Local Institution, Kursk

344022

Local Institution, Rostov-on-Don

344029

Local Institution, Rostov-on-Don

350012

Local Institution, Krasnodar

350042

Local Institution, Krasnodar

400001

Local Institution, Volgograd

400067

Local Institution, Kandivili West

400107

Local Institution, Volgograd

410024

Local Institution, Saratov

410028

Local Institution, Saratov

410053

Local Institution, Saratov

410054

Local Institution, Saratov

411011

Local Institution, Pune

426000

Local Institution, Izhevsk

500082

Local Institution, Panjagutta, Hyderabad

560010

Local Institution, Bangalore

560052

Local Institution, Vasanth Nagar

560054

Local Institution, Bangalore

600023

Local Institution, Vladimir

603018

Local Institution, Nizhny Novgorod

603126

Local Institution, Nizhny Novgorod

610030

Local Institution, Kirov

614095

Local Institution, Perm

625023

Local Institution, Tuymen

630047

Local Institution, Novosibirsk

630087

Local Institution, Novosibirsk

632004

Local Institution, Vellore, Tamilnadu

650066

Local Institution, Kemerovo

680004

Local Institution, Chennai

680086

Local Institution, Chennai

790015

Local Institution, Lviv

02914

Safe Harbor Clinical Research, East Providence

C1426EGP

Local Institution, Belgrano

B7602CBM

Local Institution, Buenos Aires

C1117ABH

Local Institution, Buenos Aires

C1425AGC

Local Institution, Buenos Aires

C1406GWY

Local Institution, Capital Federal

B1902COS

Local Institution, La Plata

B1708IFF

Local Institution, Morón

CP1405

Local Institution, San Martín

B2930DGO

Local Institution, San Pedro

CP5500

Local Institution, Mendoza

A4400EMI

Local Institution, Salta

CP2000

Local Institution, Rosario

C1408INH

Local Institution, Buenos Aires

C1505CWB

Local Institution, Buenos Aires

01244

Local Institution, São Paulo

04020

Local Institution, São Paulo

01307

Local Institution, Dresden

O1219

Local Institution, Dresden

334 003

Local Institution, Rajasthan

06124

Local Institution, Perugia

06700

Local Institution, Mexico City

88-140

Local Institution, Gniewkowo

66-400

Local Institution, Gorzów Wielkopolski

05-080

Local Institution, Izabelin

31-159

Local Institution, Krakow

20-538

Local Institution, Lublin

05-119

Local Institution, Michalow-Regionow

03-563

Local Institution, Warsaw

50-127

Local Institution, Wroclaw

41-800

Local Institution, Zabrze

00983

Local Institution, Carolina

00716

Local Institution, Ponce

00717

Local Institution, Ponce

00926

Local Institution, Rio Pieoras

00909

Local Institution, San Juan

00920

Local Institution, San Juan

03680

Local Institution, Kyiv

Sponsors

Lead Sponsor

AstraZeneca
All Listed Sponsors
lead

AstraZeneca

INDUSTRY