EC grants Marketing Authorisation to Boehringer Ingelheim and Lilly’s Jentadueto for diabetes

Published on July 25, 2012 at 5:02 AM · No Comments

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) received Marketing Authorisation from the European Commission for Jentadueto® which combines the DPP-4 inhibitor, linagliptin and metformin in a single tablet. Linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes.

"We're delighted that linagliptin/metformin hydrochloride (HCl) will soon be available across Europe to help people with Type 2 Diabetes," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Many patients need more than one treatment to adequately manage their diabetes. Linagliptin/metformin hydrochloride (HCl) offers a simplified, single tablet dosing option, to improve glycaemic control and with a favourable side effect profile."

The European Commission has approved linagliptin/metformin hydrochloride (HCl) for use alongside diet and exercise to improve glycaemic control in 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 percent 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. HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. 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.

Linagliptin/Metformin HCl Clinical Trials

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:

  • Statistically significant, placebo-corrected mean HbA1c reductions of -1.7 percent
  • Statistically significant reductions in fasting plasma glucose (FPG) of -60 mg/dL. FPG is used to determine glucose levels in a fasting state (usually upon waking in the morning)

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 (5 mg, once-daily) is marketed as Trajenta® across Europe and Canada, as Tradjenta® in the US, and Trazenta® in Japan, as well as in additional markets.

Source:

Boehringer Ingelheim

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