FDA

Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced that the US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin / metformin hydrochloride) tablets, used for treating adults with type 2 diabetes.

Jentadueto is a prescription medicine containing two diabetes medicines, the DPP-4 inhibitor linagliptin and metformina, and is taken twice-daily along with diet restrictions and exercise to improve glycemic control in adults with type 2 diabetes.

The approval of jentadueto is backed by a 24-week randomised double-blind placebo-controlled factorial study evaluating 791 adult patients with type 2 diabetes and showed that, at the maximum dose, the drug demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) or A1C) levels of up to 1.7%.

A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months.

Boehringer Ingelheim Pharmaceuticals Cardiovascular and Metabolic disorders marketing vice president David Pass said jentadueto, the product of a Boehringer Ingelheim and Lilly diabetes alliance, may help people with type 2 diabetes to control their blood sugar levels.

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Texas Institute for Kidney and Endocrine Disorders professor Lance Sloan said the combination of two diabetic medications in a single tablet provides a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate.

"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," Sloan added.

The company said jentadueto can be used alone or in combination with sulfonylurea, and is not intended for the treatment of type 1 diabetes or diabetic ketoacidosis.

Headquartered in Germany, Boehringer Ingelheim operates globally with 145 affiliates and has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

Image: Jentadueto, a type 2 diabetes drug, has received FDA clearance.