Navigation Links
Investigational Compound Once-Daily Lixisenatide Demonstrated Significant Improvement in Glucose Control in Patients with Type 2 Diabetes

PARIS, Sept. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

"These results demonstrated lixisenatide as a once daily GLP-1 agent with substantial A1C reduction and a pronounced effect on post-meal glucose control," said Dr. John E. Gerich of the University of Rochester School of Medicine and an investigator of the presented study. "The pronounced effect on postprandial glucose control provides a rationale to investigate the combined effect of lixisenatide and long-acting insulins in patients with type 2 diabetes."

The safety and efficacy of lixisenatide as monotherapy in patients with type 2 diabetes was assessed in a 12-week, randomized, double-blind, multicenter Phase III study. The study found that lixisenatide monotherapy administered once daily significantly improved glycemic control with a pronounced postprandial effect. The study also demonstrated that the therapy had an acceptable safety profile in patients with type 2 diabetes.

A total of 361 patients with type 2 diabetes (baseline A1C levels: 7 to 10 percent, mean age 53.7 years, mean diabetes duration 2.5 years) not currently receiving glucose-lowering therapy were randomized to: lixisenatide two-step titration (10 microgram for 1 week, 15 microgram for 1 week then 20 microgram; n=120); lixisenatide one-step titration (10 microgram for 2 weeks then 20 microgram; n=119) or placebo (n=122).

Lixisenatide significantly reduced A1C levels in both titration groups versus placebo (p<0.0001). There was a significantly higher number of patients achieving A1C levels less than or equal to 6.5 percent with lixisenatide (31.9% two-step, 25.4% one-step) and <7.0 percent (52.2% two-step, 46.5% one-step) versus placebo (p<0.01).

Lixisenatide significantly reduced the mean change from baseline two-hours postprandial glucose by respectively -4.51 and -5.47 mmol/L (p<0.0001) in the one-step and two-step titration groups with mean decreases in body weight observed in all groups. In addition, lixisenatide once-daily reduced glucose excursion respectively by -3.77 and -4.36 mmol/L in the one-step and two-step titration groups with mean decreases in body weight observed in all groups.

Lixisenatide was well tolerated. Only one serious treatment-emergent adverse event (TEAE) occurred in the lixisenatide group (0.4%) versus five in the placebo group (4.1%). Nausea was the most frequent TEAE with lixisenatide (24.2% for lixisenatide 2-step, 20.2% for lixisenatide 1-step, 4.1% for placebo). The rate of symptomatic hypoglycemia was 1.7 percent and 1.6 percent in the lixisenatide and placebo groups, respectively.

About Lixisenatide (AVE 0010)Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus.  Lixisenatide was in-licensed by sanofi-aventis from Zealand Pharma A/S (Copenhagen, Denmark).

The efficacy and safety of lixisenatide once-daily is being assessed in the GetGoal Phase III clinical trial program. The GetGoal clinical trial program started in May 2008 and has enrolled more than 4,500 patients. The enrollment of the eight other studies of the GetGoal Phase III program assessing efficacy and safety of lixisenatide in adult patients with type 2 diabetes mellitus treated with various oral antidiabetic agents or insulin was completed at the end of 2009.

The next results of the GetGoal Phase III program are expected to be released in Q2 2011.

About GLP-1 Receptor Agonists GLP-1 is a naturally occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the EASD, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

About the sanofi-aventis Diabetes Division Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people living with diabetes. The Company currently has insulin products that are also available as injection pens for people with type 1 or type 2 diabetes. Following the formation of its Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood glucose monitoring solutions and the potential first regenerative treatment for diabetes.  Investigational compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide as monotherapy and in combination with basal insulin as well as long-acting insulin analogs.

About sanofi-aventisSanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.  Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: Contacts: Susan BrooksUS:Tel: 908-981-6566E-mail: Susan.Brooks@sanofi-aventis.comYanyan ChangGlobal Diabetes Division:Tel: +49 69 305 22283E-mail: Yanyan.chang@sanofi-aventis.comMarisol Peron Corporate Media Relations:Tel: +33 (0) 1 53 77 45 02 Mobile : +33 (0) 6 08 18 94 78E-mail:

SOURCE sanofi-aventis
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. 24-Week Phase 3 Study Found Investigational Drug Dapagliflozin Improved Glycosylated Hemoglobin (HbA1c) When Added to Glimepiride in Adults With Type 2 Diabetes Mellitus
2. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
3. New Data Shows Investigational Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes
4. Abbott to Present Data on Several Investigational Cancer Treatments at American Society of Clinical Oncology Annual Meeting
5. Pivotal Data for the Investigational Treatment PSD502 for Primary Premature Ejaculation in the United States to be Presented at Major Medical Meeting
6. ProUroCare to Showcase Investigational Portable Platform for Its Prostate Imaging Device at AUA 2010
7. Abbotts Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
8. Protege Encore Clinical Trial Evaluates New Investigational Approach For Individuals Recently Diagnosed With Type 1 Diabetes
9. MicuRx Pharmaceuticals Files Investigational New Drug Application for MRX-I
10. New Data Demonstrates Abbotts Investigational MitraClip(R) System Has Potential to be a Valuable Treatment Option for Patients With Mitral Regurgitation, the Most Common Heart Valve Condition
11. FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Post Your Comments:
(Date:11/25/2015)... 2015  Today AVACEN Medical announced the issue of United States patent ... Adjustment ". This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific ... Photo - ... ... ...
(Date:11/25/2015)... YORK , November 25, 2015 ... market of self-monitoring blood glucose devices was valued at ... grow with a CAGR of 5.7% during 2015 - ... geriatric population and increasing prevalence of diabetes. In addition, ... diabetes care is also contributing to the growth of ...
(Date:11/25/2015)... Pennsylvania , November 25, 2015 - ... Continuing Medical Education (CME) --> ... Continuing Medical Education (CME) --> ... Care Continuing Medical Education (CME) ... medical information products and services, will feature latest diagnostic imaging textbooks ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... ... Today, Mothers Against Drunk Driving (MADD) learned that the number of ... time since 2011. In 2014, there were 9,967 fatalities involving an alcohol impaired driver, ... Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in 2014. Drunk ...
(Date:11/25/2015)... ... November 25, 2015 , ... In honor ... Periwinkle Pioneers, individuals and groups responsible for advancing care for pulmonary hypertension (PH) ... nominated by the public, will receive special recognition throughout 2016 as part of ...
(Date:11/25/2015)... ... 25, 2015 , ... Privately owned Contract Development and Manufacturing ... its current state of the art research, development and manufacturing facility outside of ... manufacturing capacity as well as to support its clients’ growing research and development ...
(Date:11/25/2015)... ... November 25, 2015 , ... Many people know of ... weight gain, cold hands, and dry skin. But many people who find their cholesterol ... exercise regimen instead of their thyroid, especially if they don’t have any of the ...
(Date:11/25/2015)... ... November 25, 2015 , ... Since its launch in ... involving adult stem cell therapies to patients with chronic degenerative medical conditions. Now, ... a Registered Trademark (RTM). , Organizations are required to hold a registered trademark ...
Breaking Medicine News(10 mins):