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Overview

A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis

This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.

Start Date01 Feb 2015

Sponsor / Collaborator

InteKrin Therapeutics, Inc.

NCT00631007 / CompletedPhase 2

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

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.

Start Date01 Feb 2008

Sponsor / Collaborator

InteKrin Therapeutics, Inc.

NCT00952445 / CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus

The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.

Start Date01 Dec 2003

Sponsor / Collaborator

InteKrin Therapeutics, Inc.

100 Clinical Results associated with InteKrin Therapeutics, Inc.

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0 Patents (Medical) associated with InteKrin Therapeutics, Inc.

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Literatures (Medical) associated with InteKrin Therapeutics, Inc.

01 Jul 2014·Diabetes CareQ1 · MEDICINE

Can a Selective PPARγ Modulator Improve Glycemic Control in Patients With Type 2 Diabetes With Fewer Side Effects Compared With Pioglitazone?

Q1 · MEDICINE

Article

Author: Mantzoros, Christos ; Henry, Robert R. ; DePaoli, Alex M. ; Dunn, Fredrick L. ; Higgins, Linda S.

OBJECTIVEINT131 besylate is a potent, nonthiazolidinedione, selective peroxisome proliferator–activated receptor γ (PPARγ) modulator (SPPARM) designed to improve glucose metabolism while minimizing the side effects of full PPARγ agonists. This placebo-controlled study compared the efficacy and side effects of INT131 besylate versus 45 mg pioglitazone HCl in subjects with type 2 diabetes (T2D).RESEARCH DESIGN AND METHODSThis was a 24-week randomized, double-blind, placebo- and active-controlled study of 0.5–3.0 mg INT131 versus 45 mg pioglitazone or placebo daily in 367 subjects with T2D on sulfonylurea or sulfonylurea plus metformin. The primary efficacy analysis was the comparison of change from baseline to week 24 in hemoglobin A1c (HbA1c) across treatment groups. Fluid status was assessed with a prospective scoring system for lower-extremity pitting edema.RESULTSINT131 had a steep dose response for efficacy as measured by changes in HbA1c. After 24 weeks’ treatment, the 0.5-mg dose demonstrated minimal efficacy (HbA1c −0.3 ± 0.12%) and the 2-mg dose demonstrated near-maximal efficacy (HbA1c −1.1 ± 0.12%), which was not statistically different from the efficacy of 45 mg pioglitazone (HbA1c −0.9 ± 0.12%; P < 0.01 for noninferiority). With the 1-mg dose, INT131 provided significant improvements in glycemic control (HbA1c 0.8 ± 0.12; P < 0.001 vs. placebo) but with less edema, weight gain, and hemodilution than observed with 45 mg pioglitazone.CONCLUSIONSINT131 demonstrated dose-dependent reductions in HbA1c, equivalent to 45 mg pioglitazone, but with less fluid accumulation and weight gain, consistent with its SPPARM design.

100 Deals associated with InteKrin Therapeutics, Inc.

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100 Translational Medicine associated with InteKrin Therapeutics, Inc.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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