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

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 A_1c (HbA_1c or A_1C) 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. HbA_1c 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 HbA_1c 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.