A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

PHASE3CompletedINTERVENTIONAL
Enrollment

768

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2008

Conditions
Diabetes
Interventions
DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])

DRUG

Saxagliptin

Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

DRUG

Glyburide

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

DRUG

Placebo

Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

DRUG

Glyburide

Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)

DRUG

Metformin

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Trial Locations (115)

18

Local Institution, Lima

27

Local Institution, San Isidro

112

Local Institution, Taipei

402

Local Institution, Taichung

500

Local Institution, Changhua

1000

Local Institution, Manila

1102

Local Institution, Quezon

2196

Local Institution, Johannesburg

4319

Local Institution, Umhlanga

5000

Local Institution, Córdoba

6000

Local Institution, Cebu

7008

Local Institution, Cape Town

7505

Local Institution, Tygerberg

7600

Local Institution, Mar del Plata

8301

Local Institution, Kimberley

11800

Local Institution, Df

13057

Cny Family Care, East Syracuse

13059

Local Institution, Campinas

13100

Local Institution, Safed

15216

Banksville Medical Pc, Pittsburgh

17519

Local Institution, Marília

18840

Guthrie Clinic, Ltd, Sayre

19401

Pearl Clinical Research, Norristown

19713

Christiana Care Research Institute, Newark

21045

Columbia Medical Practice, Columbia

22320

Local Institution, Tijuana, B.C.

23451

Tidewater Integrated Medical Research, Virginia Beach

27262

Regional Physicians Research, High Point

28204

Metrolina Internal Medicine, Charlotte

28211

Med Res Assoc Charlotte, Charlotte

28557

Diabetes & Endocrinology Consultants, Pc, Morehead City

28675

Mountain Top Clinical Research Center, Sparta

29303

Spartanburg Medical Research, Spartanburg

29681

Upstate Pharmaceutical Research, Simsonville

29687

Southeastern Research Assoc, Taylors

30150

Local Institution, Belo Horizonte

30338

Atlanta Pharmaceutical Research Center, Inc, Dunwoody

31096

Local Institution, Haifa

32428

Family Care Assoc & Emerald Care Res Grp, Chipley

32446

Emerald Coast Research Group, Marianna

32714

Central Florida Clinical Trials, Altamonte Springs

33134

Clinical Therapeutics Corporation, Coral Gables

33136

University Of Miami Diabetes Research Inst., Miami

34741

Fpa Clinical Research, Kissimmee

42765

Family Medical Center Of Hart Co., Munfordville

44313

Daystar Clinical Research, Inc., Akron

44340

Local Institution, Guadalajara

44507

Dr Bahagwan Dass Md, Youngstown

44614

Community Health Care, Canal Fulton

44670

Local Institution, Guadalajara

45005

Triphase Research, Ltd., Franklin

45040

Albert J Weisbrot,Md&Assoc Inc, Mason

53209

Advanced Healthcare S.C., Milwaukee

53583

Local Institution, Giv‘atayim

58100

Local Institution, Holon

60021

Local Institution, Fortaleza

60430

Local Institution, B. Rodolfo Teofilo

60607

Cedar-Crosse Research Ctr, Chicago

62250

Local Institution, Cuernavaca

63128

St. Louis Center For Clinical Research, St Louis

64060

Local Institution, Monterrey

64128

Va Medical Center, Kansas City

64353

Local Institution, Tel Aviv

64710

Local Institution, Durango

Local Institution, Monterrey

66073

Local Institution, Belém

70300

Local Institution, Ẕerifin

72143

Searcy Medical Center, Searcy

72401

Reserach Solutions, Llc, Jonesboro

73109

Integris Family Care Yukon, Yukon

73132

Oklahoma Cardiovascular And Hypertension Center, Oklahoma City

74104

Utica Park Clinic, Tulsa

75650

Local Institution, Rishon LeZiyyon

77081

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

77450

Breath Of Life Research Institute, Katy

78229

Diabetes & Glandular Disease Research Assoc, Pa, San Antonio

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

78705

Capital Medical Clinic, Llp, Austin

80401

New West Physicians, Golden

89030

Nevada Alliance Against Diabetes, North Las Vegas

90023

Randall Shue, D.O., Los Angeles

90610

Local Institution, Porto Alegre

91120

Local Institution, Jerusalem

91801

Stewart Medical Group, Alhambra

92708

Southland Clinical Research Center, Inc., Fountain Valley

93720

Valley Research, Fresno

95661

Clinical Trials Research, Roseville

97210

Local Institution, Mérida

97220

Oregon Clinical Research, Portland

97401

Coordinators Plus, Llc, Eugene

99216

Office Of Dr. Gray, Spokane

119074

Local Institution, Singapore

137040

Local Institution, Seoul

443721

Local Institution, Suwon

90035003

Local Institution, Porto Alegre

06708

Phoenix Internal Medicine Associates, Llc, Waterbury

08755

Physicians Research Center, Toms River

C1406FEQ

Local Institution, Buenos Aires

C1425AGC

Local Institution, Buenos Aires

04231

Local Institution, Sao Paulo - Sp

04020

Local Institution, Vila Mariana

SAR

Local Institution, Hong Kong

Unknown

Local Institution, Kowloon

LIMA 1

Local Institution, Lima

LIMA 31

Local Institution, Lima

00983

Local Institution, Carolina

00966

Local Institution, Guaynabo

00716

Local Institution, Ponce

00717

Local Institution, Ponce

420-717

Local Institution, Kyunggi-Do

463-707

Local Institution, Kyunggi-Do

120-752

Local Institution, Seoul

130-702

Local Institution, Seoul

135-710

Local Institution, Seoul

135-720

Local Institution, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY