Drugs Xagena
European Commission has granted marketing authorization to Jentadueto, which combines the DPP-4 inhibitor, Linagliptin and Metformin in a single tablet.
Linagliptin and Metformin hydrochloride is a new single-tablet treatment option, taken twice-daily, for adults with type 2 diabetes, who are inadequately controlled on their maximal tolerated dose of Metformin alone, Metformin and a sulphonylurea, or those already being treated with the combination of Linagliptin and Metformin. It may also be used with a sulphonylurea.
In clinical trials, statistically significant, placebo-corrected mean reductions in haemoglobin A1c ( HbA1c or A1C ) levels of -1.7% were observed in patients with inadequate glycaemic control when the maximum dose of 2.5 mg Linagliptin / 1,000 mg Metformin HCI was administered twice daily.
In clinical studies, Linagliptin / Metformin HCl did not cause any significant change in body weight, and can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for type 2 diabetes.
In a 24-week, randomised, double-blind, placebo controlled study evaluating 791 patients with type 2 diabetes and inadequate glycaemic control with diet and exercise, 2.5 mg Linagliptin / 1,000 mg Metformin HCl twice daily demonstrated the following: a) statistically significant, placebo-corrected mean HbA1c reductions of -1.7%; b) statistically significant reductions in fasting plasma glucose ( FPG ) of -60 mg/dL.
The approval of Linagliptin / Metformin HCl tablets was based on clinical trials that evaluated Linagliptin and Metformin as separate tablets. Bioequivalence of Linagliptin / Metformin HCl was demonstrated in a previous study, with co-administered Linagliptin and Metformin tablets in healthy subjects with type 2 diabetes.
In clinical studies, adverse reactions were uncommon. Gastrointestinal disorders occurred most frequently during initiation therapy with Linagliptin / Metformin HCl or Metformin HCl and tended to resolve spontaneously. A comparable rate of diarrhoea was reported with Linagliptin / Metformin HCl treatment versus Metformin plus placebo. 2
Due to the impact of background therapy, hypoglycaemia was more commonly reported in patients treated with the combination of Linagliptin / Metformin HCl and sulphonylurea compared with those treated with the combination of placebo, Metformin and sulphonylurea.
Linagliptin / Metformin HCl is not intended to be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
The use of Linagliptin / Metformin HCl in combination with Insulin has not been adequately studied.
Jentadueto 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 / 1,000 mg Metformin tablets. ( Xagena )
Source: Boehringer Ingelheim, 2012
XagenaMedicine_2012
