NCT00631007

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: InteKrin Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INT131 besylate	Once-daily, oral
DRUG	Pioglitazone HCl	Once-daily, oral
DRUG	Placebo	Once-daily, oral

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2008-03-07
• Last updated: 2010-09-13
• Results posted: 2010-09-13

Locations

66 sites across 2 countries: United States, Mexico