Merck Frosst Canada's JANUMET receives Notice of Compliance in Canada

First Therapy To Combine a DPP-4 Inhibitor With Metformin

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. 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.

"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) 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.