FDA approves tablets for adult patients with type 2 diabetes

February 6, 2012

FDA has approved (linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar.

FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combined the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.

Jentadueto provides a single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the United States as Tradjenta (linagliptin) tablets.

The drug is used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

At the maximum dose, Jentadueto demonstrated placebo-corrected reductions in hemoglobin A1C (HbA1C or A1C) levels of up to 1.7% (+0.1% for placebo and -1.6% for Jentadueto). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous 2 to 3 months. Jentadueto did not cause any meaningful change in body weight. Jentadueto can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes.

According to the CDC’s National Health and Nutrition Examination Survey, approximately 60% of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen, said David Pass, PharmD, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim.

“Therefore, alternative treatment options are important because type 2 diabetes can be difficult to manage, and it is often very personal, meaning treatment regimens need to address individual patient needs,” Pass told Formulary.

“The oral diabetes market is a $15-billion market and DPP-4s are the fastest growing segment of this market,” he continued. “We believe Jentadueto will further expand this growing market and bring a new treatment option to patients and healthcare providers.”

Jentadueto was approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects.

Adverse reactions reported in greater than or equal to 5% of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhea.

Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto 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 linagliptin (1 per 538 person years vs 0 in 433 person years for comparator).

Jentadueto is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).It is not known if Jentadueto is safe and effective when used with insulin. The Jentadueto label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.

Jentadueto will reportedly be available in pharmacies across the United States early in 2012; it is expected that it will be widely accessible and available to most insured eligible patients, according to Pass.