Pooled analysis data showed improvements in glycaemic parameters, body weight and blood pressure with investigational agent

  Pooled analysis data showed improvements in glycaemic parameters, body
  weight and blood pressure with investigational agent empagliflozin* in
  adults with Type 2 Diabetes

Pooled data from four Phase III trials presented at the 49^th EASD Annual
Meeting

Business Wire

INGELHEIM, Germany & INDIANAPOLIS, US. -- September 24, 2013

For Non-US and Non-UK Media

Poster No. 943 and 944

Boehringer Ingelheim and Eli Lilly and Company today announced results from a
new analysis of pooled efficacy data from four Phase III trials that showed
treatment with investigational compound empagliflozin*, a member of the sodium
glucose cotransporter 2 (SGLT2)inhibitor class of drugs, improved glycaemic
parameters, body weight and blood pressure, in adults with Type 2 Diabetes
(T2D).^1 Data from this pooled analysis are being presented at the 49^th
European Association for the Study of Diabetes (EASD) Annual Meeting.

“Management of Type 2 Diabetes in people with elevated cardiovascular risk
represents a challenge for physicians” said John E. Gerich, M.D. Professor of
Medicine and Physiology, University of Rochester School of Medicine. “Results
from this pooled analysis showed that empagliflozin was associated with
reductions of elevated blood pressure and modest body weight loss, in addition
to improving glycaemic parameters. These are important considerations for
people with Type 2 Diabetes.”

The pooled analysis of four Phase III trials was based on efficacy data from
2,477 patients treated with empagliflozin (10mg or 25mg) for 24 weeks either
as monotherapy or as add-on to metformin, metformin with sulphonylurea, or
pioglitazone with or without metformin. This abstract only presented pooled
efficacy data; pooled safety results were presented in a separate analysis.^2

At week 24, patients administered empagliflozin 10mg and 25mg showed:^1

  *Significant reductions from baseline in HbA1c of 0.70 percent and 0.76
    percent respectively, compared to a change of -0.08 percent for placebo
  *Loss of 2.05kg and 2.25kg of body weight respectively from baseline,
    compared to a reduction of 0.24kg for placebo
  *Reductions in systolic blood pressure of 3.9mmHg and 4.3mmHg, and
    diastolic blood pressure of 1.8mmHg and 2.0mmHg, respectively. Reductions
    of 0.5mmHg in systolic blood pressure and 0.6mmHg in diastolic blood
    pressure were achieved by patients treated with placebo
  *Changes from baseline in LDL cholesterol of +3.1mg/dL and +3.9mg/dL
    respectively, versus a change of +0.8mg/dL for placebo
  *Changes from baseline in HDL cholesterol of +2.7mg/dL for both doses,
    versus a change of 0mg/dL for placebo
  *Changes from baseline in triglyceride levels of -9.7mg/dL and -1.8mg/dL
    respectively, versus a change of +2.7mg/dL for placebo

“The results presented today encourage us to further investigate the efficacy
and cardiovascular safety of empagliflozin as a potential new treatment option
for people with Type 2 Diabetes,” said Professor Klaus Dugi, Senior Vice
President Medicine, Boehringer Ingelheim.

In addition to the pooled analysis of efficacy data, Boehringer Ingelheim and
Lilly are also presenting the design of the empagliflozin cardiovascular (CV)
outcomes trial at the EASD annual meeting.

The long-term impact of treatment with empagliflozin on CV events is being
investigated in a CV outcomes event trial in patients with T2D. The
approximately four-year study of more than 7,000 patients with T2D at elevated
CV risk, is investigating the long term treatment of empagliflozin versus
placebo on CV morbidity and mortality in 42 countries at more than 620
sites.^3

The primary endpoint is time to first occurrence of CV death, non-fatal
myocardial infarction (heart attack) or non-fatal stroke. ^ In addition, the
study is assessing long term blood glucose lowering efficacy, body weight
changes, the incidence of hypoglycaemia and other safety measures. Recruitment
for EMPA-REG OUTCOME™ completed in April 2013 and the study is currently
expected to complete in 2018.

About the empagliflozin Phase III clinical trial programme

Empagliflozin is being investigated in adults with T2D in a Phase III clinical
trial programme, which has enrolled more than 14,500 patients. This programme
comprises more than 10 multinational clinical trials.

* Empagliflozin is an investigational compound. Its safety and efficacy have
not been established.

                                   ~ ends ~

Please click on the link below for “Notes to Editors” and “References”
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/24_september_2013empagliflozin.html

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Contact:

Boehringer Ingelheim GmbH
Marco Winkler
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (151) 689 46812
or
Lilly Diabetes
Tammy Hull
Communications Manager
Email: hullta@lilly.com
Phone: +1 (317) 651 9116
 
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