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

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: INT131 besylate
Drug: Placebo
Drug: Pioglitazone HCl

Registration Number: NCT00631007

Lead Sponsor: InteKrin Therapeutics, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 367

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INT131 besylate 1 mg	INT131 besylate	INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
INT131 besylate 0.5 mg	INT131 besylate	INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
placebo	Placebo	placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
INT131 besylate 2 mg	INT131 besylate	INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
INT131 besylate 3 mg	INT131 besylate	INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
pioglitazone HCl 45 mg	Pioglitazone HCl	pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward	Weeks 0-24	HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.	Weeks 0-24	The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.

Trial Locations

Locations (64): 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
Unidad Metabolica y Cardiovascular SC
🇲🇽
Cuernavaca, Morelos, Mexico
Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
🇲🇽
Mexico City, Mexico DF, Mexico
Clinical Research of South Florida
🇺🇸
Coral Gables, Florida, United States
Internal Medicine of the Rockies
🇺🇸
Colorado Springs, Colorado, United States
Clinical Research Consulting, LLC
🇺🇸
Milford, Connecticut, United States
Clinical Research of Central Florida
🇺🇸
Winter Haven, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸
Palm Harbor, Florida, United States
Endocrine Research Solutions, Inc.
🇺🇸
Roswell, Georgia, United States
Olive Branch Family Medical Center
🇺🇸
Olive Branch, Mississippi, United States
Bozeman Deaconess Internal Medicine Associates
🇺🇸
Bozeman, Montana, United States
Fairbrook Medical Clinic
🇺🇸
Hickory, North Carolina, United States
Diabetes & Endrocrinology Consultants
🇺🇸
Morehead City, North Carolina, United States
Kaleida Health Diabetes Center
🇺🇸
Buffalo, New York, United States
ResEvo LLC
🇺🇸
Cuyahoga Falls, Ohio, United States
Delaware Smith Clinic
🇺🇸
Delaware, Ohio, United States
Clinical Research Source, Inc
🇺🇸
Perrysburg, Ohio, United States
New England Center for Clinical Research
🇺🇸
Cranston, Rhode Island, United States
Lycoming Internal Medicine, Inc.
🇺🇸
Jersey Shore, Pennsylvania, United States
Your Diabetes Endocrine Nutrition Group, LLC
🇺🇸
Mentor, Ohio, United States
Tri-State Medical Group, Inc.
🇺🇸
Beaver, Pennsylvania, United States
Diabetes Center of the Southwest
🇺🇸
Midland, Texas, United States
Salem VA Medical Center R&D Office
🇺🇸
Salem, Virginia, United States
Nucleo Medico Vallarta
🇲🇽
Guadalajara, Jalisco, Mexico
Hospital Santa Engracia
🇲🇽
Monterrey, Nuevo Leon, Mexico
New Orleans Center for Clinical Research
🇺🇸
New Orleans, Louisiana, United States
Instituto Mexicano de Investigacion Clinica
🇲🇽
Mexico City, Mexico DF, Mexico
MedStar Research Institute
🇺🇸
Washington, District of Columbia, United States
Baptist Diabetes Associates, PA
🇺🇸
Miami, Florida, United States
Elite Research Institute
🇺🇸
Miami, Florida, United States
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
Creekside Endocrine Associates, PC
🇺🇸
Denver, Colorado, United States
The Center for Diabetes and Endocrine Care
🇺🇸
Hollywood, Florida, United States
International Research Associates, LLC
🇺🇸
Miami, Florida, United States
Meridien Research
🇺🇸
Tampa, Florida, United States
Executive Health and Research Associates, Inc.
🇺🇸
Atlanta, Georgia, United States
Saint Luke's Lipid and Diabetes Reseach Center
🇺🇸
Kansas City, Missouri, United States
IVA Research
🇺🇸
Cincinnati, Ohio, United States
Prestige Clinical Research
🇺🇸
Franklin, Ohio, United States
Wells Institute for Health Awareness
🇺🇸
Kettering, Ohio, United States
Medical Research South
🇺🇸
Charleston, South Carolina, United States
Quality Research, Inc.
🇺🇸
San Antonio, Texas, United States
DGD Research
🇺🇸
San Antonio, Texas, United States
Cedar-Crosse Research Center
🇺🇸
Chicago, Illinois, United States
ICCT Reseach International
🇺🇸
Chicago, Illinois, United States
American Health Network
🇺🇸
Indianapolis, Indiana, United States
Stephen R. Smith, MD
🇺🇸
Baltimore, Maryland, United States
Comprehensive Clinical Research
🇺🇸
Berlin, New Jersey, United States
UNC Diabetes Care Center/Highgate Specialty Center
🇺🇸
Durham, North Carolina, United States
The Lindner Clinical Trial Center
🇺🇸
Cincinnati, Ohio, United States
Rapid Medical Research, Inc
🇺🇸
Cleveland, Ohio, United States
Opitmed Research, LTD
🇺🇸
Columbus, Ohio, United States
L-Marc Research Center
🇺🇸
Louisville, Kentucky, United States
Diabetes and Endocrinology Specialists, Inc.
🇺🇸
Chesterfield, Missouri, United States
Hartwell Research Group
🇺🇸
Anderson, 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
Palmetto Clinical Trial Services, LLC
🇺🇸
Simpsonville, South Carolina, United States
Frederick C Smith Clinic
🇺🇸
Marion, Ohio, United States