FDA Approves Extended-Release Metformin Combo Medicine for Type 2 Diabetes

On May 31, the U.S. Food and Drug Administration (FDA) approved the combination oral diabetes medicine Jentadueto XR for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. Jentadueto XR, a joint development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, combines linagliptin (brand name Tradjenta), a DPP-4 inhibitor, and metformin (brand name Glucophage and others).

DPP-4 inhibitors work to lower blood sugar by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which 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. With DPP-4 inhibited, the incretins have longer to carry out these actions. Metformin works by decreasing the amount of glucose made by the liver and by improving insulin sensitivity in the liver, muscle, and fat cells.

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Jentadueto XR tablets are an extended-release form of Jentadueto (approved in 2012), and will be offered in doses of 2.5 milligrams of linagliptin/1,000 milligrams of metformin extended-release and 5 milligrams of linagliptin/1,000 milligrams of metformin extended-release, to be taken once daily with a meal.

The safety and effectiveness of Jentadueto XR were based on results from studies of linagliptin and metformin given together to people with Type 2 diabetes who did not achieve target blood sugar control using diet and exercise along with sulfonylurea drugs.

This medicine should not be used in people with Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body) or in those who have kidney problems. It has not been studied in people who have a history of pancreatitis (inflammation of the pancreas). As with all medicines containing metformin, this drug contains a boxed label warning on the risk for a rare but serious complication known as lactic acidosis (a buildup of lactic acid in the bloodstream).

The most commonly reported side effects of Jentadueto XR include stuffy or runny nose, sore throat, and diarrhea.

For more information about Jentadueto XR, see the piece “FDA Oks Linagliptin/Metformin Combo for Type 2 Diabetes” or the official press release.

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  • RAWLCM

    Often these combination drugs are a tricky way of getting around the patent laws that allow generic versions. When a drug patent expires, the company combines it with a compatible drug and issues a fresh patent on the “new” drug. It is sometimes possible to get the same therapeutic value for considerably less by having your doctor prescribe the generics separately. The same applies to “extended release” versions of existing drugs, with the major difference being you have to take them less often, although the active ingredients are identicle.