A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

PHASE2CompletedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

September 30, 2009

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

INT131 besylate

Once-daily, oral

DRUG

Pioglitazone HCl

Once-daily, oral

DRUG

Placebo

Once-daily, oral

Trial Locations (66)

11650

Centro Especializado en Diabetes y Obisidad (EDOPEC), Mexico City

14000

Instituto Nacional de Nutricion Salvador Zubiran (INNSZ), Mexico City

14209

Kaleida Health Diabetes Center, Buffalo

15009

Tri-State Medical Group, Inc., Beaver

17740

Lycoming Internal Medicine, Inc., Jersey Shore

20003

MedStar Research Institute, Washington D.C.

21234

Stephen R. Smith, MD, Baltimore

24153

Salem VA Medical Center R&D Office, Salem

27713

UNC Diabetes Care Center/Highgate Specialty Center, Durham

28557

Diabetes & Endrocrinology Consultants, Morehead City

28602

Fairbrook Medical Clinic, Hickory

29407

Medical Research South, Charleston

29621

Hartwell Research Group, Anderson

29681

Palmetto Clinical Trial Services, LLC, Simpsonville

30076

Endocrine Research Solutions, Inc., Roswell

30342

Executive Health and Research Associates, Inc., Atlanta

33021

The Center for Diabetes and Endocrine Care, Hollywood

33134

Clinical Research of South Florida, Coral Gables

33156

Baptist Diabetes Associates, PA, Miami

International Research Associates, LLC, Miami

33169

Elite Research Institute, Miami

33606

Meridien Research, Tampa

33880

Clinical Research of Central Florida, Winter Haven

34203

Meridien Research, Tampa

34652

Suncoast Clinical Research, Inc., New Port Richey

Suncoast Clinical Research, Inc., Palm Harbor

38654

Olive Branch Family Medical Center, Olive Branch

40213

L-Marc Research Center, Louisville

43015

Delaware Smith Clinic, Delaware

43235

Opitmed Research, LTD, Columbus

43302

Frederick C Smith Clinic, Marion

43551

Clinical Research Source, Inc, Perrysburg

44060

Your Diabetes Endocrine Nutrition Group, LLC, Mentor

44122

Rapid Medical Research, Inc, Cleveland

44223

ResEvo LLC, Cuyahoga Falls

45005

Prestige Clinical Research, Franklin

45219

The Lindner Clinical Trial Center, Cincinnati

45245

IVA Research, Cincinnati

45429

Wells Institute for Health Awareness, Kettering

46254

American Health Network, Indianapolis

59715

Bozeman Deaconess Internal Medicine Associates, Bozeman

60607

Cedar-Crosse Research Center, Chicago

60611

ICCT Reseach International, Chicago

63017

Diabetes and Endocrinology Specialists, Inc., Chesterfield

64111

Saint Luke's Lipid and Diabetes Reseach Center, Kansas City

66220

Hospital Santa Engracia, Monterrey

70119

New Orleans Center for Clinical Research, New Orleans

75230

Dallas Diabetes and Endocrine Research Center, Dallas

75231

Research Institute of Dallas, Dallas

75246

Baylor University Endocrine Center, Dallas

78209

Quality Research, Inc., San Antonio

78229

DGD Research, San Antonio

79705

Diabetes Center of the Southwest, Midland

80209

Creekside Endocrine Associates, PC, Denver

80910

Internal Medicine of the Rockies, Colorado Springs

90057

National Research Institute, Los Angeles

92161

VA San Diego Healthcare System, San Diego

92705

Apex Research Institute, Santa Ana

95608

Northern California Research, Carmichael

06460

Clinical Research Consulting, LLC, Milford

08009

Comprehensive Clinical Research, Berlin

02920

New England Center for Clinical Research, Cranston

Unknown

Nucleo Medico Vallarta, Guadalajara

Instituto Mexicano de Investigacion Clinica, Mexico City

Unidad Metabolica y Cardiovascular SC, Cuernavaca

06100

Comite Mexicano para la Prevencion de la Osteoporosis A.C., Mexico City

Sponsors
All Listed Sponsors
lead

InteKrin Therapeutics, Inc.

INDUSTRY