INGELHEIM, Germany & INDIANAPOLIS. - Tuesday, September 16th 2014 [ME NewsWire]
(BUSINESS
WIRE) Boehringer Ingelheim and Eli Lilly and Company today presented
results from a 52-week Phase III study that demonstrated sustained
efficacy of the investigational empagliflozin/linagliptin combination
tablet in adults with type 2 diabetes (T2D) already taking metformin and
in those who were previously untreated. Results from the study,
presented during the 50th Annual Meeting of the European Association for
the Study of Diabetes (EASD), also confirmed the safety profile of the
combination tablet.
“We are encouraged by the results of this study
because it showed clinically meaningful reductions in blood glucose
levels with the empagliflozin/linagliptin combination when used with or
without metformin,” said Prof Hans-J. Woerle, Vice President, Head of
medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “As Type 2
Diabetes is a complex and progressive condition, new treatment
approaches may be required to help control blood glucose and the single
tablet combination of empagliflozin/linagliptin may provide an important
option for these patients.”
About the study
In the parallel group
study, 1,363 adults with T2D were randomised to five groups to
investigate the efficacy and safety of two doses of the
empagliflozin/linagliptin combination tablet compared to two doses of
empagliflozin and one dose of linagliptin with or without metformin.
Overall, empagliflozin/linagliptin combination therapy was well
tolerated, with safety profiles similar to those known for the
individual components. Patients were randomised to one the following
treatments:
Empagliflozin 25mg/linagliptin 5mg, combination tablet
Empagliflozin 10mg/linagliptin 5mg, combination tablet
Empagliflozin 25mg
Empagliflozin 10mg
Linagliptin 5mg
Empagliflozin/linagliptin combination therapy as add-on to stable dose metformin
At
52 weeks, both empagliflozin 25mg/linagliptin 5mg and empagliflozin
10mg/linagliptin 5mg led to significant reductions in blood glucose
(HbA1c) of -1.21 and -1.04 percent, respectively, compared to baseline.
The glucose lowering effects of the other treatments were as follows:
linagliptin 5mg (-0.45 percent), empagliflozin 25mg (-0.69 percent) and
empagliflozin 10mg (-0.70 percent).
Confirmed hypoglycaemic adverse
events (AEs) were reported in 3.6 percent, 2.2 percent, 3.5 percent, 1.4
percent and 2.3 percent of subjects on empagliflozin 25mg/linagliptin
5mg, empagliflozin 10mg/linagliptin 5mg, empagliflozin 25 mg,
empagliflozin 10mg and linagliptin 5mg respectively; no subject required
assistance.
Genital infection was reported in 2.2 percent, 5.9
percent, 8.5 percent, 7.9 percent and 2.3 percent, on the same regimens
respectively. Urinary tract infections were reported in 10.2 percent,
9.6 percent, 13.5 percent, 11.4 percent and 15.2 percent, on the same
regimens respectively.
Empagliflozin/linagliptin combination therapy in previously untreated adults with T2D
At
52 weeks, both empagliflozin 25mg/linagliptin 5mg and empagliflozin
10mg/linagliptin 5mg led to reductions in blood glucose (HbA1c) compared
to baseline of -1.18 and -1.25 percent, respectively, as did
linagliptin 5mg (-0.51 percent), empagliflozin 25mg (-1.02 percent) and
empagliflozin 10mg (-0.87 percent).
The reduction in blood glucose
for empagliflozin 10mg/linagliptin 5mg combination tablet was
statistically significant compared with empagliflozin 10mg or
linagliptin 5mg; however, reductions seen with empagliflozin
25mg/linagliptin 5mg did not reach statistical significance compared
with empagliflozin 25mg.
Confirmed hypoglycaemic AEs were reported in
1 patient each in both the empagliflozin 25mg and linagliptin 5mg
groups and 4 patients on empagliflozin 10mg; no subject required
assistance.
Genital infection was reported in 5.9 percent, 2.9
percent, 4.4 percent, 5.2 percent and 3.0 percent in empagliflozin
25mg/linagliptin 5mg, empagliflozin 10mg/linagliptin 5mg, empagliflozin
25mg, empagliflozin 10mg and linagliptin 5mg. Urinary tract infections
were reported in 12.5 percent, 15.4 percent, 10.4 percent, 16.3 percent
and 10.4 percent, on the same regimens respectively.
In April this
year, Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly announced the
U.S. Food and Drug Administration (FDA) accepted the filing of the New
Drug Application for the investigational oral combination of
empagliflozin/linagliptin in a single tablet for the treatment of T2D.
If granted approval by the FDA, this combination will bring together,
for the first time into one tablet, the distinct mechanisms of action of
a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl
peptidase-4 (DPP-4) inhibitor.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/16_september_2014_diabetes.html
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140916005441/en/
Contacts
Marco Winkler
Product Communication Manager
Boehringer Ingelheim GmbH
Email: press@boehringer-ingelheim.com
Phone: +49 (151) 689 46812
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: +1 (317) 651 9116
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