CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 367 enrolled
Drug / intervention
INT131 besylate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00631007
NCT00631007Phase 2Completed
CompareCT.gov

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

InteKrin Therapeutics, Inc.·interventional·Posted Mar 7, 2008·Updated Sep 13, 2010

In Brief

A Phase 2 clinical trial evaluating INT131 besylate, Pioglitazone HCl, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 367 participants across 66 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesMexico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartFeb 1, 2008
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago

Interventions

INT131 besylatedrug

Once-daily, oral

Pioglitazone HCldrug

Once-daily, oral

Placebodrug

Once-daily, oral