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

NCT ID: NCT00631007


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
Purpose
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.
Details
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
Source
InteKrin Therapeutics, Inc.
Sponsors
InteKrin Therapeutics, Inc.
Status
Completed
Acronym
Last Updated
17 Aug 2010
URL
Official Link
Locations
Mexico, United States