Combination Type 2 Diabetes Pill Gets FDA Nod

Megan Brooks

Disclosures

January 31, 2012

January 31, 2012 — The US Food and Drug Administration (FDA) yesterday approved a combination pill containing the dipeptidyl peptidase-4 inhibitor linagliptin and metformin hydrochloride for the treatment of adults with type 2 diabetes.

The linagliptin/metformin combination sold as Jentadueto (Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly & Co) provides a single-tablet option that is taken twice daily. It can be used alone or in combination with a sulfonylurea.

As previously reported by Medscape Medical News, linagliptin (Tradjenta) received FDA approval in May 2011 for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone or in combination with other therapies.

In a 24-week, randomized, double-blind, placebo-controlled study involving 791 adults with type 2 diabetes inadequately managed with diet and exercise, linagliptin plus metformin led to reductions in hemoglobin A1c levels of up to 1.7 percentage points.

A Matter of Convenience

"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," Lance Sloan, MD, Texas Institute for Kidney and Endocrine Disorders in Lufkin noted in a statement. "The approval of Jentadueto is exciting because it combines 2 diabetes medications in a single tablet, making it a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate."

Anne L. Peters, MD, CDE, director of clinical diabetes programs at the University of Southern California in Beverly Hills, agrees, telling Medscape Medical News that the new linagliptin/metformin combination pill is a matter of "convenience only." Dr. Peters is also a member of Medscape Diabetes & Endocrinology's editorial advisory board.

The linagliptin/metformin combination pill is not indicated for patients with type 1 diabetes or those who have diabetic ketoacidosis. It has not been studied in combination with insulin. The package label contains a boxed warning alerting clinicians that serious adverse effects can occur in patients taking the drug, including lactic acidosis.

The company says the most common adverse effects with linagliptin/metformin are nasopharyngitis and diarrhea. They also note that hypoglycemia was more commonly reported in patients treated with the drug combination and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea, and metformin (22.9% vs 14.8%, respectively). Pancreatitis was reported more often in patients randomly assigned to receive linagliptin (1 per 538 person-years vs 0 in 433 person-years for comparator).

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