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

Phase 2

Completed

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.

Recruitment & 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)

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.

Locations (64): 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, 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
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Northern California Research
🇺🇸Carmichael, California, United States