A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
NCT ID: NCT00631007
Last Updated: 2010-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
367 participants
INTERVENTIONAL
2008-02-29
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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INT131 besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
INT131 besylate
Once-daily, oral
INT131 besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
INT131 besylate
Once-daily, oral
INT131 besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
INT131 besylate
Once-daily, oral
INT131 besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
INT131 besylate
Once-daily, oral
pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
Pioglitazone HCl
Once-daily, oral
placebo
placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
Placebo
Once-daily, oral
Interventions
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INT131 besylate
Once-daily, oral
Pioglitazone HCl
Once-daily, oral
Placebo
Once-daily, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
* HbA1c must be ≥7.5% and ≤10% at screening
* Fasting Plasma Glucose must be \<240 mg/dL at screening
Exclusion Criteria
* History of diabetic ketoacidosis
* NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
* Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
* Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
* Body mass index \>45 kg/m2
* Fasting triglycerides \>500 mg/dL
* Uncontrolled hypertension (sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>100 mmHg
* Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
30 Years
75 Years
ALL
No
Sponsors
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InteKrin Therapeutics, Inc.
INDUSTRY
Responsible Party
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InteKrin Therapeutics Inc.
Principal Investigators
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David Orloff, MD
Role: STUDY_DIRECTOR
Medpace, Inc.
Locations
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Northern California Research
Carmichael, California, United States
National Research Institute
Los Angeles, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Apex Research Institute
Santa Ana, California, United States
Internal Medicine of the Rockies
Colorado Springs, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
Baptist Diabetes Associates, PA
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Elite Research Institute
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, United States
Meridien Research
Tampa, Florida, United States
Meridien Research
Tampa, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Executive Health and Research Associates, Inc.
Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
ICCT Reseach International
Chicago, Illinois, United States
American Health Network
Indianapolis, Indiana, United States
L-Marc Research Center
Louisville, Kentucky, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Stephen R. Smith, MD
Baltimore, Maryland, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Diabetes and Endocrinology Specialists, Inc.
Chesterfield, Missouri, United States
Saint Luke's Lipid and Diabetes Reseach Center
Kansas City, Missouri, United States
Bozeman Deaconess Internal Medicine Associates
Bozeman, Montana, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Kaleida Health Diabetes Center
Buffalo, New York, United States
UNC Diabetes Care Center/Highgate Specialty Center
Durham, North Carolina, United States
Fairbrook Medical Clinic
Hickory, North Carolina, United States
Diabetes & Endrocrinology Consultants
Morehead City, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
IVA Research
Cincinnati, Ohio, United States
Rapid Medical Research, Inc
Cleveland, Ohio, United States
Opitmed Research, LTD
Columbus, Ohio, United States
ResEvo LLC
Cuyahoga Falls, Ohio, United States
Delaware Smith Clinic
Delaware, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
Frederick C Smith Clinic
Marion, Ohio, United States
Your Diabetes Endocrine Nutrition Group, LLC
Mentor, Ohio, United States
Clinical Research Source, Inc
Perrysburg, Ohio, United States
Tri-State Medical Group, Inc.
Beaver, Pennsylvania, United States
Lycoming Internal Medicine, Inc.
Jersey Shore, Pennsylvania, United States
New England Center for Clinical Research
Cranston, Rhode Island, United States
Hartwell Research Group
Anderson, South Carolina, United States
Medical Research South
Charleston, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Baylor University Endocrine Center
Dallas, Texas, United States
Diabetes Center of the Southwest
Midland, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
DGD Research
San Antonio, Texas, United States
Salem VA Medical Center R&D Office
Salem, Virginia, United States
Nucleo Medico Vallarta
Guadalajara, Jalisco, Mexico
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
Mexico City, Mexico DF, Mexico
Centro Especializado en Diabetes y Obisidad (EDOPEC)
Mexico City, Mexico DF, Mexico
Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
Mexico City, Mexico DF, Mexico
Instituto Mexicano de Investigacion Clinica
Mexico City, Mexico DF, Mexico
Unidad Metabolica y Cardiovascular SC
Cuernavaca, Morelos, Mexico
Hospital Santa Engracia
Monterrey, Nuevo León, Mexico
Countries
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References
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DePaoli AM, Higgins LS, Henry RR, Mantzoros C, Dunn FL; INT131-007 Study Group. Can a selective PPARgamma modulator improve glycemic control in patients with type 2 diabetes with fewer side effects compared with pioglitazone? Diabetes Care. 2014 Jul;37(7):1918-23. doi: 10.2337/dc13-2480. Epub 2014 Apr 10.
Other Identifiers
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INT131-007
Identifier Type: -
Identifier Source: org_study_id