First Therapy To Combine a DPP-4 Inhibitor With Metformin
KIRKLAND, QC, Oct. 13 /CNW/ - Merck Frosst Canada Ltd. announced today that its new diabetes treatment, JANUMET(TM) (sitagliptin/metformin HCI, MSD), has received Notice of Compliance (NoC) in Canada. JANUMET(TM) (sitagliptin/metformin HCI, MSD) is the first medicine combining a DPP-4 inhibitor with metformin in a single tablet, addressing 3 core defects associated with type 2 diabetes - insufficient insulin production and release and/or inability to use insulin produced properly, insulin resistance, and overproduction of glucose by the liver.
"A single tablet that combines two different blood glucose lowering agents will make it easier for our patients to achieve good blood glucose control and will help to delay or prevent the complications of diabetes," says Dr. Lawrence Leiter, Head, Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Ontario.
In Canada, it is estimated that there are more than two million Canadians living with type 1 and type 2 diabetes.(1) In fact, type 2 diabetes accounts for about 90 per cent of all diagnosed cases of diabetes and is one of the fastest growing diseases in Canada. The incidence of diabetes in Canada is expected to reach three million by 2010.(2)
"While the approval of JANUMET(TM) (sitagliptin/metformin HCI, MSD) is great news for those who live with type 2 diabetes, medication alone is not enough to optimally manage the disease," says Lori Berard, diabetes nurse educator, Health Sciences Centre Diabetes Research Program which is affiliated with the University of Manitoba, Winnipeg, Manitoba. "People who live with type 2 diabetes need to combine treatment with healthy eating and physical activity to help control weight and blood sugar levels," says Berard.
JANUMET(TM) (sitagliptin/metformin HCI, MSD)(3) was shown to be equivalent to sitagliptin and metformin taken separately. In a separate clinical study, patients treated with sitagliptin plus metformin compared to a sulfonylurea (glipizide, a sulfonylurea not available in Canada) plus metformin achieved similar glycemic efficacy with the added benefits of significant weight loss compared to weight gain with glipizide as well as significantly fewer episodes of hypoglycemia. In this 52-week non-inferiority clinical study, patients on metformin (greater than or equal to)1500 mg/day plus sitagliptin, compared to treatment of a sulfonylurea (glipizide) plus metformin ((greater than or equal to) 1500 mg/day), showed patients taking sitagliptin with metformin lost weight 1.5 kg compared to patients taking glipizide plus metformin who gained weight 1.1 kg. Hypoglycaemia (when blood sugar becomes too low) was more common in patients treated with glipizide plus metformin (32%) compared to patients treated with sitagliptin with metformin (4.9%).
In clinical trials with patients treated with sitagliptin and metformin, all doses of sitagliptin plus metformin were generally well-tolerated. Gastrointestinal side effects, including nausea, vomiting, abdominal pain and diarrhea, were similar to metformin alone.
"Our goal is to help patients reach glucose targets quickly and keep them there. Good blood glucose control can reduce the risk of the devastating complications including blindness, kidney damage, and cardiovascular problems, such as stroke and heart attack, yet recent surveys have suggested that half of Canadians with diabetes have glucose levels above the recommended targets. New treatment options, which help improve blood glucose levels without the risk of weight gain and too low blood sugar associated with some of our older medications, are most welcome," says Dr. Leiter.
JANUMET(TM) (sitagliptin/metformin HCI, MSD) is indicated as an adjunct to healthy eating habits and physical activity to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on metformin or in patients already being treated with the combination of sitagliptin and metformin. JANUMET(TM) (sitagliptin/metformin HCI, MSD) is currently available in Canada.
With JANUMET(TM) (sitagliptin/metformin HCI, MSD), Merck continues to build a portfolio of oral anti-diabetic agents that provide physicians with new treatment options for a broad range of patients.
About JANUMET(TM) (sitagliptin/metformin HCI, MSD)
JANUMET(TM) (sitagliptin/metformin HCI, MSD) includes two effective treatments with complementary modes of action, that of the incretin-enhancing power of a dipeptidyl peptidase-4 (DPP-4) inhibitor and the proven glucose-lowering benefits of metformin. DPP-4 inhibitors work by enhancing the body's own ability to lower blood sugar (glucose). This unique new therapy addresses 3 core defects of type 2 diabetes.
About Merck Frosst Canada Ltd
At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a research-driven pharmaceutical company. Merck Frosst discovers, develops and markets a broad range of innovative medicines and vaccines to improve human health. The Merck Frosst Centre for Therapeutic Research, one of the largest biomedical research facilities in Canada, has the mandate to discover new therapies for the treatment of infectious diseases. More information about Merck Frosst and JANUMET(TM) is available at http://www.merckfrosst.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect MSD's business, particularly those mentioned in the cautionary statements in Item 1 of MSD's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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(1) The Prevalence and Cost of Diabetes. The Canadian Diabetes
Association. Accessed September 21, 2009,
(2) The Prevalence and Cost of Diabetes. The Canadian Diabetes
Association. Accessed September 21, 2009,
(3) All clinical data referenced in this press release for JANUMET were
from studies including sitagliptin plus metformin as separate
tablets. A bioequivalence study has demonstrated the equivalence of
sitagliptin plus metformin as separate tablets and JANUMET.
SOURCE Merck Canada Inc.
For further information: For further information: or to arrange an interview, please contact: Andrea Herman, Cohn & Wolfe, (416) 924-5700 ext. 4020, email@example.com; Natacha Raphael, Merck Frosst Canada Ltd., (514) 428-3280, firstname.lastname@example.org