In an extensive clinical trial programme saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor (more commonly known as a gliptin), was shown to improve glycaemic control, with no increased risk of side-effects such as weight gain and hypoglycaemia (hypos), associated with other commonly-used oral diabetes treatments such as sulphonylureas. This was assessed by reductions against all key measures of glucose control; HbA1c, post prandial glucose (PPG) and fasting plasma glucose (FPG).
Anthony Barnett, Professor of Medicine, Consultant Physician and Clinical Director of Diabetes and Endocrinology at Heart of England NHS Foundation Trust, UK commented, "The launch of saxagliptin as a new treatment option for Type 2 diabetes in the UK is good news for both patients and clinicians. It comes at a time of change for Type 2 diabetes management in the UK with HbA1c and QOF targets having recently been reduced from ?‰¤7.5% to ?‰¤7.0% for the majority of patients and also the recent recommendations from NICE for a target HbA1c of 6.5% for the first two treatment steps. Treatments such as saxagliptin, which provide additional glycaemic control with no increased risk of hypoglycaemia, have the potential to make a real difference in helping patients reach recommended glycaemic targets."
There are currently at least 2 million people living with Type 2 diabetes in the UK. Many of these currently experience poor glycaemic control and as such are failing to reach target HbA1c levels, whilst at the same time experiencing side-effects such as hypoglycaemia and weight gain as a result of their treatment. A recent study has shown that 39% of patients taking sulphonylureas have experienced mild hypoglycaemia. Hypoglycaemia is associated with a reduced quality of life, reduced treatment satisfaction and reduced treatment adherence.
Gwen Hall, Diabetes Nurse Specialist and Clinical Educator, Surrey PCT commented, "It is clear that hypoglycaemia, a side effect associated with some of the therapies used to treat Type 2 diabetes, is relatively common and can affect an individual's quality of life. People hate having hypos and risk poor control of their diabetes to prevent them. We now have a range of therapies available to treat Type 2 diabetes and need to help people make informed choices about their medication, including those which have no increased risk of hypoglycaemia while maintaining effective control of their blood glucose levels."
The launch of saxagliptin follows marketing authorisation on 5 October 2009 by the European Medicines Agency (EMEA). The decision was reached after the Committee for Medicinal Products for Human Use (CHMP) reviewed data from a comprehensive clinical development programme that included six core Phase III trials which assessed the safety and efficacy of saxagliptin as a once-daily therapy. These involved 4,148 patients with Type 2 diabetes, including 3,021 patients treated with saxagliptin.-
In a joint statement, Frederic Duchesne, General Manager, Bristol-Myers Squibb UK and Dr Guy Yeoman, Medical Director, AstraZeneca UK commented, "The launch of saxagliptin in the UK, the first market to launch in Europe, represents a significant step forward for the Bristol-Myers Squibb and AstraZeneca diabetes collaboration as we work towards becoming a key partner in the diabetes community. Saxagliptin will provide another option for the many people with Type 2 diabetes who are not achieving optimal disease control with the current treatments available."
About Gliptins
Gliptins are a class of compounds that work by preventing the breakdown of natural hormones, incretins, which are released by the gut after food. Incretins decrease elevated blood glucose by increasing insulin production in the pancreas and decreasing glucagon secretion.
About Saxagliptin
Saxagliptin is indicated as a once-daily 5mg dose in adult patients with Type 2 diabetes to improve glycaemic control:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
- in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or
- in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.-
About Type 2 Diabetes
Type 2 diabetes is a chronic disease in which the body does not produce or properly use insulin. Type 2 diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations and nerve damage.
HbA1c is a measurement of a person's average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for Type 2 diabetes include fasting plasma glucose (FPG), a measure of a person's blood glucose after at least eight hours of fasting, and postprandial glucose (PPG), a measure of a person's blood glucose after a meal.
Sources
Bristol-Myers Squibb and AstraZeneca
View drug information on Glucagon; Onglyza.
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