Study Finds Investigational Compound Empagliflozin Reduced Blood Glucose In Adults With Type 2 Diabetes And Impaired Kidney Function

Date: Jun-26-2013Data presented at American Diabetes Association 73rd Scientific Sessions® also showed reductions in weight and blood pressure

Boehringer Ingelheim and Eli Lilly and Company have announced results of a 52week Phase III clinical trial of the investigational compound empagliflozin*, which showed statistically significant reductions in HbA1c (average blood glucose) at week 24, with the addition of empagliflozin to existing oral glucoselowering therapy in people with Type 2 Diabetes (T2D) and mild to moderate renal impairment as measured by the estimated glomerular filtration rate (eGFR ≥60 to body weight and significant improvements in blood pressure with empagliflozin versus placebo in patients with mild to moderate renal impairment.1

"Today, nearly half of all new cases of kidney failure are due to diabetes. The Boehringer Ingelheim and Lilly Diabetes alliance is using its collective knowledge to find new treatment options that meet the different needs of people with diabetes," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "This data demonstrated the potential for empagliflozin in people with Type 2 Diabetes, including people with renal impairment".

At week 24, results of the study with empagliflozin in patients with renal impairment included:
Placeboadjusted reductions in HbA1c of 0.52% (p
Decrease in fasting plasma glucose (FPG) levels in patients with mild renal impairment of 13.88 mg/dL (p
Loss of 1.76kg (p
Improvements in both systolic (SBP) and diastolic blood pressure (DBP) with empagliflozin versus placebo:
SBP decreased in patients with mild renal impairment by 2.9mmHg (p=0.033) and 4.5mmHg (p=0.002) for empagliflozin 10mg and 25mg, respectively, while it increased by 0.7mmHg for placebo; SBP decreased in patients with moderate renal impairment by 3.9mmHg (p=0.001) for empagliflozin 25mg, and increased by 0.4mmHg for placebo1
DBP decreased in patients with mild renal impairment by 1.4mmHg (p=0.006) and 2.2mmHg (p
In this study group of people with T2D and mild or moderate renal impairment, the percentage of people who reported adverse events at 24 weeks were: 79.6%, 75.4% and 72.7% on empagliflozin 10mg, 25mg and placebo, respectively. Common adverse events include hypoglycaemia (plasma glucose ≤70mg/dL and/ or requiring assistance reported in  23.5% of patients on empagliflozin 10mg, 22.1% on empagliflozin 25mg and 22.9% on placebo), as well as adverse events consistent with  urinary tract infection (reported in 10.2% of patients on empagliflozin 10mg, 9.0% on empagliflozin 25mg and 8.2% on placebo) and genital infection (reported in 6.1% of patients on empagliflozin 10mg, 2.5% on empagliflozin 25mg and 1.3% on placebo).

At 52 weeks, results of the study showed placeboadjusted reductions in HbA1c of 0.62% (pAbout the study

The 52week randomised, doubleblind, placebocontrolled trial investigated the safety and efficacy of empagliflozin as an addon to existing therapy in people with T2D and renal impairment.1 The primary endpoint was change from baseline in HbA1c at week 24. Exploratory endpoints included changes from baseline in FPG, weight and blood pressure at week 24.1

About 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 people. 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.
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