Health Canada approves ONGLYZA for type 2 diabetes treatment

ONGLYZA(TM) (saxagliptin) approval coincides with new research that shows 91 per cent of Canadians with diabetes are drifting in the management of their disease

Bristol-Myers Squibb Canada and AstraZeneca Canada today announced that Health Canada has approved ONGLYZA(TM) (saxagliptin) which improves all three key measures of glycemic control - hemoglobin A1c (A1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG) - when taken in combination with other commonly used oral anti-diabetic agents (metformin or a sulfonylurea). Taken once daily, ONGLYZA provides additional help to patients when first-line therapy fails to provide sufficient glycemic control.

"Diabetes is the third most frequently diagnosed disease by physicians in Canada and, due to complications, patients with the condition visit their doctor more than adults without diabetes," explained Dr. Stewart Harris lead investigator for the National Diabetes Management Strategy who holds the Canadian Diabetes Association Chair in Diabetes Management at the Schulich School of Medicine & Dentistry. "New treatments provide additional options to physicians which ultimately, will facilitate improved patient outcomes."

Disconnect exists between Canadians' perceptions of effective management and reality of "diabetes drift"

According to a recent national survey of adults with type 2 diabetes, 87 per cent believe they are effectively managing their disease, however, even more - 91 per cent - admit that they do not fully comply with diabetes management behaviours recommended by the Canadian Diabetes Association.

The research indicates that people drift from healthy to unhealthy behaviours beginning, on average, 21 months after diagnosis. For example, 76 per cent of respondents claimed to have modified their diet upon first diagnosis, but within 14 months, 74 per cent had regressed to former eating habits. Accompanying this shift in behaviour, respondents identified strongly with feelings of frustration/anger (45 per cent), guilt/embarrassment (36 per cent) and depression/sadness (32 per cent) as adherence waned.

"The survey identifies a critical stage in the patient journey where motivation declines and added support and recommitment is crucial to effectively managing diabetes to prevent long-term complications," commented Dr. Michael Vallis, Psychologist, Queen Elizabeth II Health Sciences Centre. "Almost all respondents - 94 per cent - believe it is possible to live an active, healthy life with diabetes. These findings reflect the urgent need to identify best practices for empowering patients through this important phase of the disease."

Other highlights of the survey include: - Residents of Quebec are more likely than residents of any other region to feel that their doctor pressures them to continue lifestyle changes (85 per cent compared to 47 per cent of residents in Saskatchewan and Manitoba). - Ontarians with type 2 diabetes are least compliant compared to any other region at taking their medication as prescribed (66 per cent versus 82 per cent in both Quebec and Atlantic Canada). - Residents of British Columbia and Ontarians who are living with type 2 diabetes are most likely to agree that being physically active is important (95 per cent for both provinces). However, they are also most likely to drift from an exercise program (71 per cent in British Columbia, 69 per cent in Ontario). - Fewer than one in three Albertans with type 2 diabetes (28 per cent) say that they always maintain a healthy body weight. Though they are drifting with their diabetes control, 75 per cent do not think that their health is getting worse. - Atlantic Canadians, more than any other region in Canada, are most likely to drift in their control of diabetes when measuring the following lifestyle changes: - Following a balanced meal plan: At 15 per cent, Atlantic Canadians are only half as likely to follow a balanced meal plan compared to residents in Saskatchewan and Manitoba (32 per cent). - Maintaining a healthy weight: Only 12 per cent of Atlantic Canadians affirm that they always comply with this recommended lifestyle change compared to 28 per cent of Albertans.

New option for patients not well controlled on first-line therapy

ONGLYZA is a dipeptidyl peptidase-4 (DPP-4) inhibitor which works by affecting the action of hormones - incretins - to increase insulin production in the pancreas and reduce the liver's production of glucose. It is prescribed to patients who are failing to gain adequate glycemic control through first-line therapies and diet and exercise alone. The majority - 83 per cent - of survey respondents claim that they do not want to rely on insulin to control their diabetes.

"More than two million Canadians are living with diabetes and almost half are uncontrolled in their current treatment regime," said Mark Jones, President & CEO, AstraZeneca Canada. "AstraZeneca Canada, through our collaboration with Bristol-Myers Squibb Canada, is proud to provide doctors and their patients a new treatment option in ONGLYZA to help them better manage their diabetes."

"Developed in collaboration between Bristol-Myers Squibb and AstraZeneca, ONGLYZA draws on the strengths of both companies and represents the first significant milestone in our shared commitment to supporting advances in this important disease area," said Wayne Quigley, President, Bristol-Myers Squibb Canada. "We are excited about ONGLYZA's potential to assist people in achieving glucose control so that they may enjoy healthier lives and prevent complications."

Diabetes is a complex chronic illness that is affecting Canadians at an alarming pace. Estimates suggest that by 2010, three million Canadians will have diabetes and this will drain $15.6 billion from the health care system per year. A challenging illness that brings serious health consequences when treatment is lacking, diabetes requires constant monitoring and vigilance on the part of patients and physicians alike.

Clinical Data Support

In patients with type 2 diabetes, the addition of ONGLYZA 5 mg to metformin or a sulfonylurea resulted in statistically significant improvements in A1c,fasting plasma glucose (FPG), and postprandial glucose (PPG), including 2-hour PPG following standard oral glucose test (OGTT), compared to metformin or a sulfonylurea alone. The recommended adult dose is 5 mg, once daily, taken with or without food.

Source: ASTRAZENECA CANADA INC.