Navigation Links
InteKrin Therapeutics Presented Phase 2b Clinical Data at the 2010 American Diabetes Association Annual Meeting, Demonstrating Improved Glycemic Control in Patients with Type 2 Diabetes Without Causing the Edema Seen with Pioglitazone
Date:6/29/2010

LOS ALTOS, Calif., June 29 /PRNewswire/ -- InteKrin Therapeutics presented 6 month Phase 2b clinical data for edema in diabetic patients showing differentiation for INT131, a Selective PPAR-gamma Modulator (SPPARM), from Actos® (pioglitazone), yesterday at the American Diabetes Association annual meeting in Orlando, FL.

INT131 besylate (INT131) is a novel, non-TZD, selective oral PPAR-gamma modulator (SPPARM) designed to improve glucose metabolism while minimizing the side effects of the TZD full PPAR-gamma agonists such as Actos®: fluid retention (edema), CHF, bone fracture, and weight gain. The Phase 2b trial, INT131-007, was a 366 patient 24 wk double blind study comparing 4 doses of INT131 to maximal dose Actos® (pioglitazone) or placebo in patients with poorly controlled T2DM on stable dose sulfonylurea (SU) with or without metformin (met). Lower extremity edema was assessed with a predefined scoring tool designed for maximal sensitivity for pitting edema at baseline, 12, and 24 wks. Results show INT131 improved glycemic control as measured by HbA1c comparable to Actos® but without evidence of any significant change in edema compared to baseline or placebo. Substantial edema was noted in the pioglitazone group, consistent with published data. These findings support the SPPARM function of INT131 and suggest it represents a safer insulin sensitizer.

"This data clearly differentiates INT131 besylate from pioglitazone with respect to the important clinical parameter of edema," remarked Dr. Alex DePaoli, Acting Chief Medical Officer of InteKrin Therapeutics, who presented the data. "These findings are consistent with previous clinical data and support the advantages of the SPPARM nature of this agent."

"Insulin sensitization is a core therapeutic mechanism for addressing the Type 2 Diabetes epidemic," added Dr. Linda Higgins, President & Chief Operating Officer of InteKrin Therapeutics. "INT131 besylate offers a potential significant advance in addressing the critical need for a safe insulin sensitizer."

About INT131:

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of Type 2 Diabetes. As a selective PPAR-gamma modulator (SPPARM), INT131 has been designed to provide potent glucose lowering and durability of effect without the recognized side effects of the currently available insulin sensitizers which, unlike INT131, are full PPAR-gamma agonists. InteKrin has completed an End-Of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for INT131 and is moving the program into Phase 3 development.

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin's business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.


'/>"/>
SOURCE InteKrin Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes with INT131
2. InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study
3. InteKrin Therapeutics to Present at the 2009 American Diabetes Association Annual Meeting
4. InteKrin Therapeutics Presents Positive Long Term INT131 Preclinical Cardiovascular Safety Data at the 45th Annual European Association for the Study of Diabetes Meeting
5. InteKrin Therapeutics Co-Founder Receives Appointment as Professor of Medicine at Harvard Medical School
6. InteKrin Therapeutics to Present Phase 2b Clinical Data for Edema at the 2010 American Diabetes Association Annual Meeting
7. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
8. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
11. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 27, 2016 , ... Quality metrics are proliferating in cancer care, and are ... the eye of the beholder, according to experts who offered insights and commentary in ... Managed Care. For the full issue, click here . , For the American ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... they have been diagnosed with endometriosis. These women need a treatment plan to ... a comprehensive approach that can help for preservation of fertility and ultimately achieving ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
Breaking Medicine News(10 mins):