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New Diabetes Combination Drug Given FDA Approval
Fri, 03 Feb 2012
A new type 2 diabetes treatment from pharmaceutical giants Eli Lilly and Boehringer Ingelheim has been approved by the US Food and Drug Administration (FDA) to help adult diabetics better control their condition.

Jentadueto is a twice-daily prescription medication that combines DPP-4 inhibitor, linagliptin, and metformin in a single tablet, to improve glycemic control, in combination with diet and exercise .

The drug joins a number of other metformin/DPP-4 inhibitor combinations, including sitagliptin (Janumet) and saxagliptin (Kombiglyze).

Approval of Jentadueto was based on a 24-week randomized controlled trial of 791 adults with type 2 diabetes and inadequate blood sugar control .

The results showed that the combination agent improved glycated hemoglobin (HbA1c) levels compared with placebo. The mean reduction in HbA1c levels was 1.6 pc with 2.5 mg linagliptin plus 1,000 mg metformin, compared with a 0.1 pc increase for the placebo.

Common side effects included stuffy or runny nose and sore throat, as well as diarrhea, but there was no significant change in body weight.

The drug is also approved for use in combination with a sulfonylurea, but cannot be used by patients with kidney disease or diabetic ketoacidosis (increased ketones in the blood or urine).

Earlier this week, Amylin Pharmaceuticals’ diabetes drug Bydureon finally received FDA approval after being twice rejected by the regulator due to claims of potential side effects to the heart. The once-weekly injectable drug is a longer-acting form of Amylin‘s older Byetta treatment.
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