A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

565

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2008

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)

DRUG

Placebo

Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)

DRUG

pioglitazone

Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)

DRUG

rosiglitazone

Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)

DRUG

metformin

Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Trial Locations (133)

1

Local Institution, Lima Cercado

13

Local Institution, La Victoria

18

Local Institution, Miraflores

27

Local Institution, San Isidro

31

Local Institution, San Martín de Porres

33

Local Institution, Santiago de Surco

1600

Local Institution, Cebu City

Local Institution, Pasig

1740

Local Institution, Las Piñas

1824

Local Institution, Lanus Este

1900

Local Institution, La Plata

5000

Local Institution, Iloilo City

6000

Local Institution, Cebu City

10700

Local Institution, Angeles Del Pedregal

15216

Banksville Medical Pc, Pittsburgh

19056

Family Medical Associates, Levittown

19438

Harleysville Medical Associates, Harleysville

20232

Local Institution, Aguascalientes

23294

National Clinical Research, Inc., Richmond

23451

Tidewater Integrated Medical Research, Virginia Beach

28211

Medical Research Associates Of Charlotte, Inc., Charlotte

28625

Carolina Pharmaceutical Research, Statesville

29201

Three Rivers Medical Associates, Pa, Columbia

29651

Radiant Research, Greer, Greer

29681

Upstate Pharmaceutical Research, Simpsonville

30060

Marietta Clinical Research, Inc., Marietta

30076

Endocrine Research Solutions, Inc., Roswell

30338

Alan B. Miller, Md, Dunwoody

31000

Local Institution, Chichuahua

32205

Jacksonville Center For Clinical Research, Jacksonville

32428

Southern Family Healthcare, Pa, Chipley

32435

Doctors Medical Center Of Walton County, DeFuniak Springs

32446

Panhandle Family Care Associates, Marianna

32714

Central Florida Clinical Trials, Inc., Altamonte Springs

33021

Horizon Institute For Clinical Research, Hollywood

33145

Nextphase Clinical Trials, Inc, Miami

33156

Baptist Diabetes Associates, Miami

34239

Heart & Vascular Center Research, Inc., Sarasota

35565

Winston Technology, Inc., Haleyville

36360

Iicr, Inc., Ozark

36606

Sunbelt Research Group, Llc, Mobile

37209

Hayes Endocrine And Diabetes Center, Nashville

37701

East Tennessee Medical Group, Alcoa

37813

Healthstar Physicians, Morristown

38654

Olive Branch Family Medical Center, Olive Branch

44122

Rapid Medical Research, Inc., Cleveland

44614

Community Health Care, Canal Fulton

44718

Clinical Research Limited, Canton

45200

Local Institution, Zapopan

45429

Wells Institute For Health Awareness, Kettering

45439

Providence Health Partners - Center For Clinical Research, Dayton

45631

Holzer Clinic, Gallipolis

46250

Physicians Research Group, Indianapolis

46383

Northwest Indiana Center For Clinical Research, Valparaiso

49024

Promed Physicians Family Practice, Portage

52242

Lipid Research Clinic, Iowa City

58000

Local Institution, Michoacan

60607

Cedar-Crosse Research Center, Chicago

66260

Local Institution, Monterrey

67203

Professional Research Network Of Kansas, Wichita

71291

Mouhaffel, Assad H., West Monroe

72205

Little Rock Family Practice Clinic, Little Rock

72401

Nea Clinic, Jonesboro

75246

Priscilla Hollander, Md, Phd, Dallas

75503

Collom And Carney Clinic, Texarkana

76104

The Medical Group Of Texas, Fort Worth

77024

Mobley Research Center, Houston

77074

Family Physician, Pa, Houston

77081

Mapleridge Medical Center, Houston

77471

Med-Cure, Rosenberg

77584

Pearland Primary Care Associates, Llp, Pearland

78229

Radiant Research San Antonio, San Antonio

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

78705

Capital Medical Clinic, Llp, Austin

78731

Texas Diabetes And Endocrinology, P.A., Austin

78752

Radiant Research-Austin, Austin

79705

Diabetes Center Of The Southwest, Midland

80209

Denver Internal Medicine Group, Denver

83404

Southeast Idaho Family Practice, Idaho Falls

85213

Clinical Research Advantage, Inc, Mesa

89030

Nevada Alliance Against Diabetes, North Las Vegas

89146

Radiant Research Las Vegas, Las Vegas

90025

Peak Health Medical Group, Los Angeles

90211

Impact Clinical Trials, Beverly Hills

Lovelace Scientific Resources, Inc., Beverly Hills

90255

Del Rosario Medical Clinic, Inc., Huntington Park

91436

Medical Group Of Encino, Encino

92260

Desert Medical Advances, Palm Desert

92357

Loma Linda Va Healthcare Systems, Loma Linda

92691

Mission Internal Medical Group, Mission Viejo

94904

Marin Endocrine Care And Research, Inc., Greenbrae

95032

Richard Cherlin, Md, Los Gatos

96732

D. Thomas Rogers, Md, Facs, Kahului

97401

David Witkin, Md, Eugene

132001

Local Institution, Hariyāna

400021

Local Institution, Mumbai

400067

Local Institution, Mumbai

411011

Local Institution, Maharashtra

Local Institution, Pune

452001

Local Institution, Indore

500082

Local Institution, Hyderabad

560010

Local Institution, Bangalore

560054

Local Institution, Bangalore

575001

Local Institution, Mangalore

600010

Local Institution, Chennai

600013

Local Institution, Chennai

600086

Local Institution, Chennai

632004

Local Institution, Vellore

680004

Local Institution, Chennai

06905

Stamford Therapeutics Consortium, Stamford

06708

Phoenix Internal Medicine Associates, Llc, Waterbury

07733

Office Of Ammar Bazerbashi, Md, Holmdel

08880

Urgentmed, P.C., South Bound Brook

C1426EGP

Local Institution, Belgrano

C1408INH

Local Institution, Buenos Aires

B6740CWC

Local Institution, Chacabuco

C1505CWB

Local Institution, Ciudad Auton.

B17081FF

Local Institution, Morón

M5519XAC

Local Institution, Mendoza

S2000CVD

Local Institution, Rosario

C1425AGC

Local Institution, Buenos Aires

A1E 2C2

Local Institution, St. John's

B3H 2Y9

Local Institution, Halifax

N7T 4X3

Local Institution, Sarnia

L2R 7P3

Local Institution, St. Catharines

H1S 3A9

Local Institution, Saint-Léonard

G1V 4G2

Local Institution, Ste-Foy

S7K 3H3

Local Institution, Saskatoon

00983

Local Institution, Carolina

00716

Local Institution, Ponce

00717

Local Institution, Ponce

00926

Local Institution, Rio Piedras

00920

Local Institution, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY