INGELHEIM, Germany & INDIANAPOLIS, US--(BUSINESS WIRE)--A Phase III clinical trial has found that empagliflozin in combination with metformin reduces blood glucose levels in adults with type 2 diabetes (T2D). Boehringer Ingelheim and Eli Lilly and Company presented these findings in a late-breaking poster at the American Diabetes Association’s (ADA) 75th Scientific Sessions®. The 24-week study compared dual therapy of empagliflozin and metformin to monotherapy of either empagliflozin or metformin in patients with T2D.
“The American Diabetes Association recommends a blood sugar level below seven percent for many people with type 2 diabetes and we are encouraged that more adults achieved HbA1c levels lower than 7.0 percent after 24 weeks in the empagliflozin and metformin combination group than either the metformin or empagliflozin group,” said Professor Hans-J. Woerle, Vice President, Head of Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim.
The HbA1c test, expressed as a percentage, provides a measure of average blood sugar levels over the past two to three months.
The primary endpoint of this study of 1,364 randomised adults with T2D was change from baseline in HbA1c at 24 weeks. Patients enrolled in this study were not receiving any glucose lowering therapy for at least 12 weeks prior to the start of the trial and had a mean baseline HbA1c of approximately 8.7 percent.
All four empagliflozin and metformin combination doses showed statistically significant reductions in HbA1c vs. the individual components of empagliflozin or metformin. Statistical models showed the following estimated average HbA1c level reductions from baseline:
- Empagliflozin 12.5 mg bid/metformin 1000 mg bid: 2.08 percent
- Empagliflozin 12.5 mg bid/metformin 500 mg bid: 1.93 percent
- Empagliflozin 5 mg bid/metformin 1000 mg bid: 2.07 percent
- Empagliflozin 5 mg bid/metformin 500 mg bid: 1.98 percent
- Empagliflozin 25 mg qd: 1.36 percent
- Empagliflozin 10 mg qd: 1.35 percent
- Metformin 1000 mg bid: 1.75 percent
- Metformin 500 mg bid: 1.18 percent
Changes from baseline in fasting plasma glucose (FPG) and weight were exploratory analyses. Patients in this study had a mean baseline FPG of approximately 169.6 mg/dL. The empagliflozin and metformin combinations resulted in larger reductions in FPG versus either empagliflozin or metformin alone. The empagliflozin and metformin combinations also resulted in a statistically significant reduction in weight versus metformin monotherapy.
The overall frequency of adverse events (AEs) was consistent across all patient groups (56.7 - 66.3 percent). The percentage of patients with confirmed hypoglycaemic AEs (glucose ≤70mg/dL and/or requiring assistance) was low in all groups (0-1.8 percent); none required assistance.
Initial combination treatment with empagliflozin and metformin was part of an investigational trial. The fixed dose combination of empagliflozin and metformin hydrochloride (Synjardy®) was approved for the treatment of T2D in adults on 27 May 2015 in the European Union, but is not approved for first line use.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about the global business of the Diabetes Alliance. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
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Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/08_june_2015_empagliflozin.html
