FDA Approves Combo Type 2 Medicine

On the heels of its recent approval of the injectable drug Bydureon, the US Food and Drug Administration has approved linagliptin/metformin hydrochloride (brand name Jentadueto), an oral medicine for Type 2 diabetes manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., and Eli Lilly and Company. Jentadueto combines the DPP-4 inhibitor linagliptin (Tradjenta) with the commonly prescribed diabetes drug metformin.

DPP-4 inhibitors work by helping a hormone known as incretin to stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. Metformin works by decreasing glucose production by the liver, as well as improving insulin sensitivity in the liver, muscle, and fat cells.

Jentadueto tablets are approved for use in conjunction with diet and exercise in people with Type 2 diabetes alone or in combination with a sulfonylurea (a drug class that includes Diabinese, Diabeta, Glynase, Micronase, Glucotrol, Glucotrol XL, and Amaryl). In studies, the using maximum dose of the drug led to a 1.7% reduction in A1C (an indicator of blood glucose control over the previous 2–3 months) compared to placebo.

The medicine comes in three tablet strengths of 2.5 milligrams of linagliptin/500 milligrams metformin, 2.5 milligrams of linagliptin/850 milligrams of metformin, and 2.5 milligrams of linagliptin/1000 milligrams of metformin, respectively. It should be taken twice daily with meals, with the dose being escalated gradually to minimize any gastrointestinal symptoms from the metformin.

This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). The medicine should also not be used in people who have kidney problems.

The most common side effects of Jentadueto are stuffy or runny nose, sore throat, and diarrhea. Like metformin alone, Jentadueto carries a small but serious risk of lactic acidosis (a potentially fatal condition in which lactic acid builds up in the blood, depriving the body’s tissues of oxygen).

For more information, see the press release on the Eli Lilly Web site or see Jentadueto’s Web site.