Navigation Links
LX4211 Achieves Positive Results in Type 2 Diabetes Patients with Renal Impairment

THE WOODLANDS, Texas, Oct. 1, 2013 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that LX4211, a first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), successfully met the primary endpoint of reducing post-prandial glucose, in a study of patients with type 2 diabetes and moderate to severe renal impairment.  Reducing elevated post-prandial glucose, high blood sugar levels after meals, is a key objective of diabetes therapy.

In a placebo-controlled, proof-of-concept study, LX4211 provided clinically meaningful and statistically significant reductions (p<0.05) in post-prandial glucose in diabetes patients with moderate to severe renal impairment (Stage 3 and 4 kidney disease). Importantly, these effects were maintained in a sub-group with the most advanced renal impairment, pre-defined as those with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2. LX4211 also produced significant elevations in GLP-1, a hormone involved in control of glucose and appetite.

Renal impairment occurs in approximately 30% of patients with type 2 diabetes and represents a major unmet medical need with limited treatment options.  LX4211's inhibition of SGLT1 in the gastrointestinal (GI) tract, reducing glucose absorption and triggering GLP-1 secretion, offers the potential for treating this medically challenging population with compromised kidney function.  In previous Phase 2 studies, LX4211 improved glycemic control in patients with type 2 diabetes with normal renal function.

"Our hypothesis was that LX4211 would improve glycemic control even in patients with the greatest degree of renal impairment due to its inhibition of SGLT1 in the GI tract," said Pablo Lapuerta, M.D., Lexicon's chief medical officer.  "The post-prandial glucose reductions and GLP-1 elevations observed in this study population support the rationale for demonstrating effective HbA1c reduction in a larger, longer-term Phase 3 trial, and provide further support for the clinical differentiation of LX4211 as a first-in-class dual SGLT1 and SGLT2 inhibitor." 

In this multicenter study, 30 patients with poorly controlled type 2 diabetes and moderate to severe renal impairment were randomized to either placebo or a 400 mg dose of investigational drug LX4211 taken orally once per day before breakfast. Patients' post-prandial glucose was measured after a standardized meal both at baseline before treatment and after one week of therapy. In addition to achieving the primary efficacy objective of post-prandial glucose reduction, there were no serious adverse events observed in the study and no discontinuations of LX4211 due to adverse events. Lexicon plans to present full results of the study at scientific congresses in 2014.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease.  Lexicon currently has multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications, all of which were discovered by Lexicon's research team.  Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets.  Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.  For additional information about Lexicon and its programs, please visit

Safe Harbor Statement

This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX4211, characterizations of the results of and projected timing of clinical trials of LX4211, and the potential therapeutic and commercial potential of LX4211.  The press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information.  All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements.  Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange Commission.  Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Lexicon Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
2. Lexicon Presents Data Regarding the Mechanism of Action and Safety of LX4211 at American Diabetes Association Meeting
3. Lexicon Announces Positive Results of LX4211 Phase 2b Trial For Type 2 Diabetes
4. Lexicon Announces Publication of Results of Two Studies of LX4211 in Patients with Type 2 Diabetes in the Journal Clinical Pharmacology & Therapeutics
5. LX4211 Phase 2b Results Presented At American Heart Association Annual Conference
6. Lexicon Advances LX4211 In Type 1 Diabetes Phase 2 Trial
7. Lexicon Presents Data at the American Diabetes Association Meeting On Blood Pressure Reduction and Weight Loss In Clinical Trial of LX4211
8. Greenville Hospital System Achieves Dramatic Improvement in Hand Hygiene Compliance Rates Using New Technology from DebMed®
9. Acuo Technologies Grows European Business and Achieves Successful Connectathon Results in Bern, Switzerland
10. CMC Biologics Achieves Successful Pre-Approval European GMP Inspection by MHRA for Commercial Manufacturing
11. QIAGEN Achieves Personalized Healthcare Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer
Post Your Comments:
(Date:11/30/2015)... , Nov. 30, 2015   Royal Philips ... Implant, the industry,s first MRI guided user interface and ... of patients with MR Conditional implants, such as knee ... 2015 Radiological Society of North America Annual Meeting ... and supports diagnostic confidence of this growing patient population. ...
(Date:11/30/2015)... BOCA RATON, Fla. , Nov. 30, ... of Public Research (the Institute) announced today that ... , a medical device start-up company with technology developed ... creation based on publicly-funded research, and bridges early funding ... -based universities and research institutions. ...
(Date:11/30/2015)... Nov. 30, 2015 Baxalta Incorporated ... leader dedicated to delivering transformative therapies to ... conditions, today announced the launch and first ... an extended circulating half-life recombinant factor VIII ... full-length ADVATE [Antihemophilic Factor (Recombinant)]. The treatment ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... ... Centers’ National Poison Data System (NPDS) reveals that in 2014, someone called a ... cases, over two million of which were human exposure cases. , The American ...
(Date:11/30/2015)... ... November 30, 2015 , ... Brenntag Specialties, Inc. ... partner for the Nutraceutical Specialties products into oral solid dosage in the over ... , “We are pleased to announce our expanded distribution agreement with ASI.” said ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... announced at the Radiology Society of North America (RSNA) annual meeting, being held ... 60% growth from 2014. Throughout 2015, the company has completed installations for ...
(Date:11/30/2015)... ... November 30, 2015 , ... Holcomb – Kreithen Plastic ... surgery practices in Florida, is proud to announce that Dr. Joshua Kreithen, one ... Ethicon Inc., a Johnson & Johnson Company. , Ethicon is a global medical ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... strategic alliance around Novus’ TIGR® Matrix Surgical Mesh technology for soft tissue repair ... polymers, TIGR® Matrix is a long-term resorbable surgical mesh intended to support and ...
Breaking Medicine News(10 mins):