Study Shows Reduction In Blood Glucose With Investigational Compound Empagliflozin Used To Treat Adults With Type 2 Diabetes

Date: Jun-26-2013Data presented at the American Diabetes Association 73rd Scientific Sessions® also showed statistically significant reductions in mean daily glucose and body weight in treated study subjects

Boehringer Ingelheim and Eli Lilly and Company have announced results of two Phase III 24week clinical trials of the investigational compound empagliflozin* added to metformin with and without the addition of sulphonylurea, respectively, in people with Type 2 Diabetes (T2D). These results showed statistically significant reductions in blood glucose among people who received empagliflozin, as measured by reductions in HbA1c (average blood glucose) after 24 weeks.1,2

Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by reducing glucose reabsorption in the kidney.

The studies, presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose and body weight.1,2 Overall adverse events were reported in a similar percentage of patients treated with empagliflozin 10mg, empagliflozin 25mg and placebo, respectively.

"Metformin is the foundation of treatment for Type 2 Diabetes in people without clinically relevant renal impairment. However, many people don't meet their blood sugar target due to the progressive nature of the condition and have difficulties managing other risk factors such as weight and increased blood pressure," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The results from this study of empagliflozin as an addon to metformin or metformin plus sulphonylurea therapies are promising for people with Type 2 Diabetes".

24week study with empagliflozin as an addon to metformin

In this 24week randomised, doubleblind, placebocontrolled trial, the addition of empagliflozin to a background of metformin showed a placeboadjusted reduction in HbA1c of 0.57% (purinary tract infection (reported in 5.1% of patients on empagliflozin 10mg, 5.6% on empagliflozin 25mg and 4.9% on placebo) and genital infection (reported in 3.7% of patients on empagliflozin 10mg, 4.7% on empagliflozin 25mg and none on placebo).

24week study with empagliflozin as an addon to metformin and sulphonylurea

In this 24week randomised, doubleblind, placebocontrolled trial, the addition of empagliflozin to a background of metformin plus sulphonylurea therapy showed a placeboadjusted reduction in HbA1c of 0.64% (pAbout the empagliflozin phase III clinical trial programme

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that plans to enrol more than 14,500 patients. This programme comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

*Empagliflozin is an investigational compound. Its safety and efficacy have not been established.
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.