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
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.