A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes
1 other identifier
interventional
367
2 countries
66
Brief Summary
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Feb 2008
Typical duration for phase_2 type-2-diabetes-mellitus
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
September 13, 2010
CompletedSeptember 13, 2010
August 1, 2010
1.5 years
February 27, 2008
August 18, 2010
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Weeks 0-24
Secondary Outcomes (1)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
Weeks 0-24
Study Arms (6)
INT131 besylate 0.5 mg
EXPERIMENTALINT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
INT131 besylate 1 mg
EXPERIMENTALINT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
INT131 besylate 2 mg
EXPERIMENTALINT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
INT131 besylate 3 mg
EXPERIMENTALINT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
pioglitazone HCl 45 mg
ACTIVE COMPARATORpioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
placebo
PLACEBO COMPARATORplacebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
Interventions
Once-daily, oral
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
- 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
You may not qualify if:
- History of type 1 diabetes
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Northern California Research
Carmichael, California, 95608, United States
National Research Institute
Los Angeles, California, 90057, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Internal Medicine of the Rockies
Colorado Springs, Colorado, 80910, United States
Creekside Endocrine Associates, PC
Denver, Colorado, 80209, United States
Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
MedStar Research Institute
Washington D.C., District of Columbia, 20003, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
Baptist Diabetes Associates, PA
Miami, Florida, 33156, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Elite Research Institute
Miami, Florida, 33169, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34652, United States
Meridien Research
Tampa, Florida, 33606, United States
Meridien Research
Tampa, Florida, 34203, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Executive Health and Research Associates, Inc.
Atlanta, Georgia, 30342, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
ICCT Reseach International
Chicago, Illinois, 60611, United States
American Health Network
Indianapolis, Indiana, 46254, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Stephen R. Smith, MD
Baltimore, Maryland, 21234, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Diabetes and Endocrinology Specialists, Inc.
Chesterfield, Missouri, 63017, United States
Saint Luke's Lipid and Diabetes Reseach Center
Kansas City, Missouri, 64111, United States
Bozeman Deaconess Internal Medicine Associates
Bozeman, Montana, 59715, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Kaleida Health Diabetes Center
Buffalo, New York, 14209, United States
UNC Diabetes Care Center/Highgate Specialty Center
Durham, North Carolina, 27713, United States
Fairbrook Medical Clinic
Hickory, North Carolina, 28602, United States
Diabetes & Endrocrinology Consultants
Morehead City, North Carolina, 28557, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
IVA Research
Cincinnati, Ohio, 45245, United States
Rapid Medical Research, Inc
Cleveland, Ohio, 44122, United States
Opitmed Research, LTD
Columbus, Ohio, 43235, United States
ResEvo LLC
Cuyahoga Falls, Ohio, 44223, United States
Delaware Smith Clinic
Delaware, Ohio, 43015, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Frederick C Smith Clinic
Marion, Ohio, 43302, United States
Your Diabetes Endocrine Nutrition Group, LLC
Mentor, Ohio, 44060, United States
Clinical Research Source, Inc
Perrysburg, Ohio, 43551, United States
Tri-State Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Lycoming Internal Medicine, Inc.
Jersey Shore, Pennsylvania, 17740, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Hartwell Research Group
Anderson, South Carolina, 29621, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, 75230, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Baylor University Endocrine Center
Dallas, Texas, 75246, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
DGD Research
San Antonio, Texas, 78229, United States
Salem VA Medical Center R&D Office
Salem, Virginia, 24153, United States
Nucleo Medico Vallarta
Guadalajara, Jalisco, Mexico
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
Mexico City, Mexico DF, 06100, Mexico
Centro Especializado en Diabetes y Obisidad (EDOPEC)
Mexico City, Mexico DF, 11650, Mexico
Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
Mexico City, Mexico DF, 14000, 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, 66220, Mexico
Related Publications (1)
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.
PMID: 24722496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Executive Officer
- Organization
- InteKrin Therapeutics
Study Officials
- STUDY DIRECTOR
David Orloff, MD
Medpace, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
September 13, 2010
Results First Posted
September 13, 2010
Record last verified: 2010-08