Health Canada Approves BYETTA® Injection Added On To Insulin Glargine For Adult Patients With Type 2 Diabetes

TORONTO, Sept. 19, 2012 /CNW/ - Eli Lilly Canada is pleased to announce that Health Canada has approved BYETTA® (exenatide) injection added on to insulin glargine (with or without metformin) to improve glycemic control in adult patients with type 2 diabetes mellitus when insulin glargine (with or without metformin) in addition to diet and exercise does not provide adequate glycemic control. Insulin glargine is a type of long-acting insulin analogue used to produce a steady level of insulin between meals and overnight.

"Type 2 diabetes is a complicated condition that requires regular monitoring and individualized treatment," said Dr. Bernard Zinman, Director of the Leadership Sinai Centre for Diabetes, Professor of Medicine, University of Toronto and Mount Sinai Hospital. "In addition to a healthy lifestyle which includes a balanced diet and exercise, recent studies have shown that GLP-1 receptor agonists when used with insulin appears to be a particularly effective treatment combination and Canadians with type 2 diabetes can use this strategy to better manage their condition."

Adding BYETTA in a fixed dose, twice daily before meals, can help improve control of patients' blood sugars overall as well as after meals. In a clinical study, patients on BYETTA with insulin glargine (alone or in combination with metformin), achieved better glycemic control, without increased hypoglycemia or weight gain.1

About BYETTA (exenatide) injection
BYETTA is also indicated in combination with metformin and/or sulfonylurea, or insulin glargine (with or without metformin) to improve glycemic control in patients with type 2 diabetes mellitus.2  It is self-administered as a fixed dose injection before morning and evening meals3 and is in a class of diabetes treatments called GLP-1 receptor agonists.  GLP-1 receptor agonists mimic several antihyperglycemic actions of incretins.4,5

In the three placebo-controlled pivotal clinical trials where BYETTA was used in combination with metformin and/or a sulfonylurea, the most commonly observed adverse reactions in BYETTA-treated patients were: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache and dyspepsia. Adverse reactions were usually mild to moderate in intensity. In the three pivotal studies, the incidence of nausea was dose-dependent and most common in the initial weeks of exenatide treatment or after an increase in exenatide dose.6 When BYETTA was used in combination with insulin glargine, the incidence and type of adverse events observed were generally similar to those seen in the placebo-controlled pivotal clinical trials of BYETTA with metformin and/or a sulfonylurea.7

About Diabetes in Canada
Today, more than nine million Canadians live with diabetes or pre-diabetes.8  Diabetes is a contributing factor in the deaths of approximately 41,500 Canadians each year, and approximately 80 per cent of people with diabetes will die as a result of heart disease or stroke.9

About Eli Lilly Canada Inc.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs more than 500 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca.

® Trademark of Amylin Pharmaceuticals, Inc. and is used under license by Eli Lilly Canada Inc.

References:
1 John B. Buse, MD, et AL, Use of Twice-Daily Exenatide in Basal Insulin-Treated Patients With Type 2 Diabetes. American College of Physicians. 2011; 154:103-112.
2 BYETTA Product Monograph. Indications and Clinical Use.  Eli Lilly Canada.  July 27, 2012.
3 BYETTA Product Monograph. Dosage and Administration.  Eli Lilly Canada. July 27, 2012.
4 Nielsen LL, Baron AD, Pharmacology of exenatide (synthetic exendin-4) for the treatment of type 2 diabetes. Curr Opinion Invest Drugs. 2003; 4:401-405.
5 Parkes DG, Pittner R, Jodka C, Smith P, Young A, Insulinotropic actions of exendin-4and glucagon- like peptide-1 in vivo and in vitro. Metabolism. 2001; 50:583-589.
6 BYETTA Product Monograph. Adverse Reactions. Eli Lilly Canada. July 27, 2012.
7 BYETTA Product Monograph. Adverse Reactions. Eli Lilly Canada. July 27, 2012.
8 Canadian Diabetes Association.  The prevalence and costs of diabetes. The Changing Face of Diabetes in Canada. http://www.diabetes.ca/diabetes-and-you/what/prevalence/ (Accessed August 7, 2012).
9 Canadian Diabetes Association.  The prevalence and costs of diabetes. The Cost of Diabetes. http://www.diabetes.ca/diabetes-and-you/what/prevalence/ (Accessed August 7, 2012). 

SOURCE: Eli Lilly

For further information:

Helen Stone
Manager, Communications
Eli Lilly Canada Inc.
416-693-3169

Shaday Livingston
Environics Communications
416-969-2759
Slivingston@environicspr.com

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