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Combination Type 2 Diabetes Pill Approved in Europe


July 27, 2012 — The European Commission has approved the combination pill containing the dipeptidyl peptidase-4 inhibitor linagliptin and metformin hydrochloride for the treatment of adults with type 2 diabetes, alongside diet and exercise. The approval follows a favorable recommendation by the European Medicines Agency in May.
The linagliptin/metformin combination sold in Europe as Jentadueto (Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly & Co) provides a single-tablet option that is taken twice daily.
It is intended for patients with type 2 diabetes that is inadequately controlled on their maximal tolerated dose of metformin alone, metformin plus a sulfonylurea, or those already being treated with the combination of linagliptin and metformin. It can be used alone or in combination with a sulfonylurea.
As previously reported by Medscape Medical News, the linagliptin/metformin combination was approved by the US Food and Drug Administration earlier this year.
In a 24-week, randomized, double-blind, placebo-controlled study involving 791 adults with type 2 diabetes inadequately managed with diet and exercise, 2.5 mg linagliptin/1000 mg metformin led to mean reductions in hemoglobin A1c levels of 1.7 percentage points. Statistically significant reductions in fasting plasma glucose (FPG) of −60 mg/dL were also seen.
In clinical studies, linagliptin/metformin did not cause any significant change in body weight.
Adverse reactions were uncommon in clinical studies. Gastrointestinal disorders occurred most often during the initiation period and tended to resolve spontaneously. A comparable rate of diarrhea was reported with linagliptin/metformin treatment vs metformin plus placebo.
Hypoglycemia was more commonly reported in patients treated with the combination of linagliptin/metformin and a sulfonylurea compared with those treated with the combination of placebo, metformin, and a sulfonylurea.
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.
Linagliptin/metformin combination tablets will be made available in the following twice-daily doses in Europe: 2.5 mg linagliptin/850 mg metformin tablets and 2.5 mg linagliptin/1000 mg metformin tablets.

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