TORONTO, Jan. 3, 2008/CNW/ - Merck Frosst Canada Ltd. announced today that Januvia(TM) (sitagliptin phosphate monohydrate), a once-daily, oral medication in a new class of anti-hyperglycemic agents known as DPP-4 (dipeptidyl peptidase-4) inhibitors, has been approved by Health Canada. Sitagliptin is approved in combination therapy with metformin, a commonly prescribed diabetes medication, to improve blood sugar (glucose) control in adult patients with type 2 diabetes when diet and exercise plus metformin do not provide adequate glycemic control. "Many Canadians with type 2 diabetes continue to face challenges in optimizing their diabetes control. The introduction of sitagliptin provides an important and innovative new option for the management of type 2 diabetes, which will be welcome news for patients and health care providers across Canada," said Dr. Daniel Drucker, Professor of Medicine and Director of the Banting and Best Diabetes Centre in Toronto.
Enhances a natural body system to significantly lower elevated blood sugar
Sitagliptin represents a new and different approach to lowering blood sugar in patients with type 2 diabetes. Sitagliptin enhances a natural body system called the incretin system, which helps regulate glucose levels in the blood. Incretins are hormones produced in the gut in response to a meal. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose. Sitagliptin keeps these hormones active for a longer period of time by preventing their breakdown. One in two Canadians being treated for type 2 diabetes does not achieve the targeted HbA1c level (average blood sugar level over three months) of less than or equal to 7 per cent as per the Canadian Diabetes Association Guidelines. The percentage of patients with type 2 diabetes who do not achieve adequate blood sugar control increases the longer the patients have the disease.(1)
More than twice as many patients reached an HbA1c of less than 7 percent with sitagliptin added to metformin
In a 24-week study of 701 patients with type 2 diabetes who were inadequately controlled on metformin alone, sitagliptin 100 mg was added to metformin. In this study, more than twice as many patients uncontrolled on metformin alone reached a level of HbA1c less than 7 per cent when sitagliptin was added, (47 per cent with sitagliptin and metformin vs. 18 per cent for patients continuing on metformin alone) (p less than 0.001). The regimen of sitagliptin and metformin also provided significant improvements in FPG (fasting plasma glucose) and 2-hour PPG (postprandial blood glucose).(2)
Not associated with weight gain or increased risk of hypoglycemia
In a pre-specified analysis, the incidence of hypoglycemia (very low blood sugar) in patients treated with sitagliptin plus metformin (1.3%) was similar to patients treated with placebo and metformin (2.1%).(2) Long-term maintenance of effect was evaluated in a 52-week, double-blind, glipizide (a sulfonylurea agent)-controlled trial in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy at greater than or equal to 1500 mg/day. In this study, the incidence of hypoglycemia in the sitagliptin group (4.9%) was significantly lower than that in the glipizide group (32.0%). Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glipizide (-1.5 kg vs. +1.1 kg).(2) Sitagliptin was generally well tolerated in controlled clinical studies in combination therapy with an overall incidence of side effects similar to that reported with placebo.(2)
Diabetes, an emerging health problem
Currently there are more than two million Canadians living with type 1 and type 2 diabetes.(3) It is estimated that over three million Canadians will be diagnosed with diabetes by 2010.(3) Type 2 diabetes accounts for 90 per cent of all diagnosed cases of diabetes(4) but it has been estimated that about one third of adults with type 2 diabetes are unaware of their condition.(5) Most patients with type 2 diabetes eventually require multiple drugs with different mechanisms of action to achieve glycemic control because of the progression of the disease. There is a need for new therapies to help patients manage their blood glucose levels.
Commitment to diabetes
Recognizing the toll that diabetes is taking globally, Merck Frosst is committed to the research and development of diabetes medications to bring new treatment options to physicians and patients who struggle with managing the complexity of type 2 diabetes. JANUVIA(TM) was awarded the Prix Galien USA 2007 Award for the Best Pharmaceutical Agent. The Prix Galien recognizes outstanding achievement in the pharmaceutical industry in the development of new medicines.
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