Patients with type 2 diabetes on metformin had greater HbA1c and blood pressure reductions and lost more weight with the addition of empagliflozin than glimepiride, according to a presentation at the 50th European Association for the Study of Diabetes Annual Meeting.
In a randomized, double blind, 2-year phase 3 trial comparing safety and efficacy of the drugs as add-ons, researchers in Europe also observed a lower risk for hypoglycemia with empagliflozin (Jardiance, Boehringer Ingelheim) compared with glimepiride.
“Empagliflozin as an add-on to metformin is safe and effective, and the effect is consistent over time, superior to that of glimepiride,” Martin Ridderstråle, MD, vice president of Steno Diabetes Center in Gentofte, Denmark, told Endocrine Today. “[Empagliflozin] produced a decrease in HbA1c, weight and blood pressure.”
Ridderstråle and colleagues from other institutions evaluated patients (mean age, 55.9 years; BMI, 30.1; HbA1c, 7.92) assigned to empagliflozin 25 mg (n=765) or glimepiride 1 mg to 4 mg (n=780) for 104 weeks.
Change from baseline in HbA1c was the primary endpoint. Secondary endpoints included changes from baseline in weight, systolic BP and diastolic BP, as well as occurrence of confirmed hypoglycemic adverse events (plasma glucose ≤70 mg/dL and/or requiring assistance).
At the end of the study, HbA1c decreased more with empagliflozin (–0.66%) vs. glimepiride (–0.55%). Fewer hypoglycemic adverse events were reported with empagliflozin (2.5% of patients) vs. glimepiride (24.2% of patients; adjusted RR=0.102; 95% CI, 0.065-0.162); assistance was required by zero patients with empagliflozin and two with glimepiride.
Greater reductions were observed in weight (–3.1 kg vs. 1.3 kg) and systolic BP (–3.1 mm Hg vs. 2.5 mm Hg) with empagliflozin than glimepiride. The mean change in diastolic BP was –1.8 mm Hg with empagliflozin compared with 0.9 mm Hg with glimepiride, representing a difference of –2.7 mm Hg (95% CI, –3.4 to –1.9).
Adverse events were reported in 86.4% of patients treated with empagliflozin and 86.3% of patients treated with glimepiride, with events consistent with genital infection reported in 11.8% and 2.2% of patients, respectively.
“[Empagliflozin] can safely and effectively be used, as is stated in the approval by both the FDA and EU commission,” Ridderstråle said. — by Allegra Tiver
For more information:
Ridderstråle M. Abstract #2. Presented at: 50th EASD Annual Meeting; Sept. 16-19, 2014; Vienna.
Disclosure: The research was supported by Boehringer Ingelheim and Eli Lilly.