INGELHEIM, Germany & INDIANAPOLIS, US--(BUSINESS WIRE)--For Non-US and Non-UK Media
Boehringer Ingelheim and Eli Lilly and Company today announced results of a 52-week 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 glucose-lowering 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 <90mL/min/1.73m2 and eGFR ≥30 to <60mL/min/1.73 m2).1
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.
Results from the study, presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, also demonstrated a significant reduction in 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:
- Placebo-adjusted reductions in HbA1c of 0.52% (p<0.001) and 0.68% (p<0.001) for empagliflozin 10mg and 25mg, respectively, in patients with mild renal impairment; for empagliflozin 25mg, placebo-adjusted reductions in HbA1c of 0.42% (p<0.001) in patients with moderate renal impairment1
- Decrease in fasting plasma glucose (FPG) levels in patients with mild renal impairment of 13.88 mg/dL (p<0.001) and 18.08mg/dL (p<0.001) for empagliflozin 10mg and 25mg, respectively, and an increase of 5.67mg/dL for placebo; in patients with moderate renal impairment, a decrease in FPG levels of 9.26mg/dL (p<0.001) for empagliflozin 25mg and an increase of 10.16mg/dL for placebo1
- Loss of 1.76kg (p<0.001) and 2.33kg (p<0.001) of body weight in patients with mild renal impairment for empagliflozin 10mg and 25mg, respectively, compared with a loss of 0.33kg for placebo; loss of 0.98kg (p<0.001) in body weight in patients with moderate renal impairment for empagliflozin 25mg, compared with a loss of 0.08kg for placebo1
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<0.001) for empagliflozin 10mg and 25mg, respectively, while it increased by 1.1mmHg for placebo; DBP decreased in patients with moderate renal impairment by 1.7mmHg (p=0.020) for empagliflozin 25mg, and increased by 0.2mmHg for placebo.1
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 placebo-adjusted reductions in HbA1c of 0.62% (p<0.001) and 0.65% (p<0.001) for empagliflozin 10mg and 25mg, respectively, in patients with mild renal impairment. In patients with moderate renal impairment, results at 52 weeks showed placebo-adjusted reductions in HbA1c of 0.44% (p<0.001) for empagliflozin 25mg. Across all randomised groups at 52 weeks, adverse events were reported by 87.8% and 83.5% of patients on empagliflozin 10mg and 25mg respectively, and 84.6% on placebo.
About the study
The 52-week randomised, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin as an add-on 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.
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_empagliflozin1.html