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

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...

Date First Received: February 27, 2008

Last Updated: November 25, 2008

Verified by: InteKrin Therapeutics, Inc., November 2008

Clinical Trial Phase: Phase 2 | Start Date: February 2008

Overall Status: Recruiting

Estimated Enrollment: 360

Brief Summary

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”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

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: 1
    • Dose Level A
  • Experimental: 2
    • Dose Level B
  • Experimental: 3
    • Dose Level C
  • Experimental: 4
    • Dose Level D
  • Active Comparator: 5
  • Placebo Comparator: 6

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in HbA1c
    • Time Frame: Every 6 weeks
      Safety Issue?: No

Secondary Measures

  • Change in fasting plasma glucose (FPG), insulin, C-peptide, serum lipids, C-reactive protein (CRP), and body weight
    • Time Frame: Every 6 weeks
      Safety Issue?: No
  • Efficacy and Safety of INT131 besylate compared with pioglitazone
    • Time Frame: Every 6 weeks
      Safety Issue?: Yes
  • Safety and tolerability of INT131 besylate as assessed by biochemical, physical and subjective clinical measures
    • Time Frame: Every 6 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Clinical Trial Sponsor Information

Lead Sponsor: InteKrin Therapeutics, Inc.

Overall Clinical Trial Officials and Contacts

David Orloff, MD Study Director Medpace, Inc.  

Overall Contact: Jennifer Kelch 513-579-9911 j.kelch@medpace.com

Related Publications

References

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Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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