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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631007
• Other study ID #: INT131-007
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: August 18, 2010
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: InteKrin Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INT131 besylate
Once-daily, oral
• Pioglitazone HCl
Once-daily, oral
• Placebo
Once-daily, oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
InteKrin Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.	The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.	Weeks 0-24	No