Lilly, Boehringer Ingelheim receive positive opinion from EMA for Jentadueto

Boehringer IngelheimMay 28 2012

Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto™, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta^® tablets) and metformin in a single tablet. If approved by the European Commission, linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes who need to improve control of their blood glucose. In clinical studies, linagliptin/metformin HCl demonstrated benefit to patients by offering another dosing option with effective glycaemic control and a favourable side effect profile.    

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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 or those already being treated with the combination of linagliptin and metformin. In clinical trials, statistically significant, placebo-corrected mean reductions in haemoglobin A_1c (HbA_1c 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.

"The CHMP positive opinion for Jentadueto™ marks another important regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Across Europe many people with Type 2 Diabetes require more than one treatment to adequately manage their diabetes. As a single-tablet treatment, we believe that Jentadueto™ will help patients with Type 2 Diabetes achieve and maintain glycaemic control and improve overall wellbeing."

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 recommendation for 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 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 (0.9 percent and 1.2 per cent respectively). 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 (22.9 percent versus 14.8 percent, respectively).

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.