A combination of a branded drug from Boehringer Ingelheim and Eli Lilly and a drug widely available in generic form has been shown in a phase III trial to be effective in treating type 2 diabetes.

Boehringer and Lilly’s Trajenta (linagliptin) in combination with metformin was shown to be more effective in controlling blood glucose levels than metformin alone.

Metformin, a successful glucophage drug for control of type 2 diabetes, was developed by Bristol-Myers Squibb and is now available in multiple branded and generic formulations.

Both drugs are used as monotherapies for type 2 diabetes in the UK, and some doctors already prescribe them together; but the new findings are likely to make the combination a standard treatment option.

The 24-week trial, part of a wider phase III study of the combination, showed that poorly controlled patients who received both drugs achieved an average reduction of 3.7% in HbA1c.

The drug combination was well tolerated, with only 9% of patients suffering side-effects and only 1.5% suffering hypoglycaemic events.

A previous one-year monotherapy trial had shown Trajenta to be of similar efficacy to glimepiride but with a significantly lower risk of side-effects, hypoglycaemic events and weight gain.

Trajenta is also the only approved diabetes medication with no need for dose adjustment in adult patients.

Professor Klaus Dugi, Corporate Senior VP of Medicine at Boehringer Ingelheim, said: “Many patients with high HbA1c levels require more than metformin alone to reach their blood glucose targets. Linagliptin can support patients with type 2 diabetes to effectively manage their condition.”

Boehringer Ingelheim and Eli Lilly have received Marketing Authorisation from the European Commission (EC) for its type 2 diabetes tablet Trajenta (linagliptin).

The EC has approved Trajenta in combination with metformin and metformin plus sulphonylurea after clinical trials involving approximately 6,000 adults showed it reduced haemoglobin A1c (HbA1c) levels.

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, says Trajenta has been shown to be a “reliable and efficacious treatment” for type II diabetes.

The tablet has also been approved for use as monotherapy in patients who have not responded to diet and exercise alone, and for whom metformin is inappropriate.

Unlike other DPP-4 inhibitors, Trajenta is primarily excreted unmetabolised via bile and gut which means there is no dose adjustment required for adult patients that may have declining kidney or liver function.

Professor Anthony Barnett, Consultant Physician, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, says that with Trajenta only available at a single 5mg dose, it is “convenient for physicians”.

“The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes,” said Enrique Conterno, President of Lilly Diabetes. “Linagliptin can be an important treatment option for people living with type II diabetes.”

Boehringer and Lilly began an alliance in January this year that centres on four pipeline compounds which represent several of the largest treatment classes in the field of diabetes.