<a href=AstraZeneca” height=”200″ src=”https://www.drugdevelopment-technology.com/wp-content/uploads/static-progressive/AstraZeneca301111.JPG” style=”padding: 10px” width=”300″ />

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.