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”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: INT131 besylate 0.5 mg
  • INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
• Experimental: INT131 besylate 1 mg
  • INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
• Experimental: INT131 besylate 2 mg
  • INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
• Experimental: INT131 besylate 3 mg
  • INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
• Active Comparator: pioglitazone HCl 45 mg
  • pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
• Placebo Comparator: placebo
  • placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl

Primary Measures

• Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
  • Time Frame: Weeks 0-24
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
  • Time Frame: Weeks 0-24
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: InteKrin Therapeutics, Inc. Industry

Overall Clinical Trial Officials and Contacts

David Orloff, MD Study Director Medpace, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631007

Study ID Number: INT131-007

ClinicalTrials.gov Identifier: NCT00631007

Health Authority: United States: Food and Drug Administration