Clinical trial NCT00631007: A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
diabetes
diabetes mellitus
diabetes mellitus, type 2
non-TZD
thiazolidinedione
selective peroxisome proliferator-activated receptor gamma modulator
SPPARM
peroxisome proliferator-activated receptor gamma
PPAR gamma
insulin sensitizer
glucose control
endocrinopathy
hypoglycemic agent
sulfonylurea
metformin
pioglitazone
nutritional and metabolic diseases
Lead sponsor: InteKrin Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 367
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
timeFrame: Weeks 0-24
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
timeFrame: Weeks 0-24
Other outcomes:
Locations:
city: Carmichael
country: United States
facility: Northern California Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Colorado Springs
country: United States
facility: Internal Medicine of the Rockies
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Washington
country: United States
facility: MedStar Research Institute
state: District of Columbia
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates, PA
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Executive Health and Research Associates, Inc.
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: ICCT Reseach International
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Stephen R. Smith, MD
state: Maryland
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialists, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Lipid and Diabetes Reseach Center
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Deaconess Internal Medicine Associates
state: Montana
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health Diabetes Center
state: New York
city: Durham
country: United States
facility: UNC Diabetes Care Center/Highgate Specialty Center
state: North Carolina
city: Hickory
country: United States
facility: Fairbrook Medical Clinic
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endrocrinology Consultants
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: IVA Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc
state: Ohio
city: Columbus
country: United States
facility: Opitmed Research, LTD
state: Ohio
city: Cuyahoga Falls
country: United States
facility: ResEvo LLC
state: Ohio
city: Delaware
country: United States
facility: Delaware Smith Clinic
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Marion
country: United States
facility: Frederick C Smith Clinic
state: Ohio
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group, LLC
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Beaver
country: United States
facility: Tri-State Medical Group, Inc.
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Lycoming Internal Medicine, Inc.
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Hartwell Research Group
state: South Carolina
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Research Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor University Endocrine Center
state: Texas
city: Midland
country: United States
facility: Diabetes Center of the Southwest
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: DGD Research
state: Texas
city: Salem
country: United States
facility: Salem VA Medical Center R&D Office
state: Virginia
city: Guadalajara
country: Mexico
facility: Nucleo Medico Vallarta
state: Jalisco
city: Mexico City
country: Mexico
facility: Comite Mexicano para la Prevencion de la Osteoporosis A.C.
state: Mexico DF
city: Mexico City
country: Mexico
facility: Centro Especializado en Diabetes y Obisidad (EDOPEC)
state: Mexico DF
city: Mexico City
country: Mexico
facility: Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
state: Mexico DF
city: Mexico City
country: Mexico
facility: Instituto Mexicano de Investigacion Clinica
state: Mexico DF
city: Cuernavaca
country: Mexico
facility: Unidad Metabolica y Cardiovascular SC
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Santa Engracia
state: Nuevo Leon
Study officials:
affiliation: Medpace, Inc.
name: David Orloff, MD
role: STUDY_DIRECTOR
References:
citation: 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.