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AstraZeneca and Bristol-Myers Squibb have announced that the European Commission has granted marketing approval for Komboglyze, used to treat adult patients with type 2 diabetes mellitus.
The once-daily Komboglyze combines saxagliptin, metformin, a biguanide plus dipeptidyl peptidase-4 inhibitor in one tablet, providing glycaemic control across glycosylated haemoglobin levels, fasting plasma glucose and post-prandial glucose.
The Komboglyze is generally administered with the evening meal and exercise to improve glycaemic control, and reduce gastrointestinal side effects associated with metformin in adult patients aged 18 years and older with type 2 diabetes.
The maximum daily recommended doses of saxagliptin and metformin are 5mg and 2,000mg respectively.
Komboglyze acts by increasing insulin secretion in a glucose-dependent manner, decreasing hepatic glucose production, and increasing peripheral glucose uptake and use.
The approval of the drug follows the review of Phase III saxagliptin development by the Committee for Medicinal Products for Human Use, and a study that involved 4,326 patients, including 2,158 individuals who received saxagliptin as well as metformin for the treatment of type 2 diabetes.
The additional studies have demonstrated the bioequivalence of Komboglyze to co-administered saxagliptin and metformin.
The Center for Disease Control and Prevention estimates that by the end of 2011, diabetes will affect nearly 53 million people aged 20-79 in Europe, a figure expected to rise to more than 64 million by 2030.
The US Food and Drug Administration-approved Komboglyze has met efficacy and safety in the two Phase III clinical trials and bioequivalence studies.
The studies evaluated the efficacy and safety of saxagliptin and metformin as separate tablets compared to placebo added to metformin, while bioequivalence was demonstrated in healthy adults between Komboglyze and saxagliptin plus metformin XR as separate tablets.
The Komboglyze combination pill is not suggested for patients with type 1 diabetes or diabetic ketoacidosis, and has not been studied in combination with insulin.