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FDA Approves Jentadueto for Type 2 Diabetes

By Carolyn Drake
Published Online: Friday, February 3, 2012
The US Food and Drug Administration (FDA) has approved Jentadueto, a type 2 diabetes treatment that combines two drugs (linagliptin and metformin) in a single pill.

From Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly, Jentadueto is a twice-daily prescription tablet designed for use in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes.

The drug’s approval is based on the results of a 24-week, randomized, double-blind, placebo-controlled study that assessed the safety and efficiency of linagliptin plus metformin when used with diet and exercise in 791 adults with type 2 diabetes.

They study found that 2.5 mg linagliptin in combination with 1,000 mg metformin twice daily resulted in a reduction of HbA1c levels of up to 1.7%.

While it is not yet known whether Jentadueto is safe and effective when used with insulin, many are excited about the approval.

"Most people with type 2 diabetes require more than one medication to help lower their blood sugar, due to the complex nature of type 2 diabetes," said Lance Sloan, MD, of the Texas Institute for Kidney and Endocrine Disorders, in a press release from the two companies.
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