Who is sponsoring NCT00631007?

NCT00631007 is sponsored by InteKrin Therapeutics, Inc..

What condition does NCT00631007 study?

NCT00631007 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT00631007?

Interventions: INT131 besylate, Pioglitazone HCl, Placebo.

What is the status of NCT00631007?

NCT00631007 is currently COMPLETED.

Last reviewed 2010-08-18 · How we verify

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

NCT00631007 Phase 2 COMPLETED Results posted

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

Lead sponsor	InteKrin Therapeutics, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	367
Start date	2008-02
Completion	2009-09

Conditions

Type 2 Diabetes Mellitus

Interventions

INT131 besylate
Pioglitazone HCl
Placebo

Primary outcomes

Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward — Weeks 0-24
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent

Countries

United States, Mexico