Pooled data from four Phase III trials presented at the 49th EASD Annual Meeting
ME Newswire / Business Wire
INGELHEIM, Germany & INDIANAPOLIS, US - Tuesday, September 24th 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 49th 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.
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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