Empagliflozin was associated with dose-dependent improvements in glycemic control and weight when added to metformin in adults with type 2 diabetes, according to researchers. The study was published online in Diabetes Care.
At week 24, patients who received 25 mg daily of the investigational selective sodium glucose cotransporter 2 (SGLT2) inhibitor had an adjusted mean change in hemoglobin A1c of –0.77%, compared with –0.70% for the 10-mg empagliflozin group and –0.13% for patients who received placebo, both highly significant differences, reported Dr. Hans-Ulrich Häring of the University of Tübingen, Germany.
Empagliflozin also significantly reduced patients’ weight and mean daily glucose level compared with placebo, and was associated with similar rates of adverse effects, noted Dr. Häring and his associates (Diabetes Care 2014 April 10 [doi: 10.2337/dc13-2105]).
The double-blind, randomized trial comprised 637 adults whose HbA1c levels remained suboptimal (defined as 7%-10%) despite a diet and exercise program and at least 12 weeks of treatment with immediate-release metformin.
In addition to the improvements in HbA1c, patients who took 25 mg empagliflozin lost an average of 2.46 kg, compared with 2.08 kg for patients who took 10 mg empagliflozin and 0.45 kg for the placebo group, the investigators reported. Likewise, mean daily glucose levels dropped 0.80 mmol/L from baseline in the 25 mg empagliflozin group, versus 0.54 mmol/L for the 10 mg group and 0.11 mmol/L for the placebo group. All these differences were statistically significant.
Rates of adverse events were 49.5%-58.7% with empagliflozin, and it was associated with a low risk of hypoglycemia (1.8%-1.4% vs. 0.5% for placebo), the investigators reported. The treatment groups had higher rates of mild to moderate genital infections than did the placebo group, but only two patients dropped out as a result, said the investigators.
"This trial demonstrates the potential of empagliflozin to be used as add-on therapy in patients with type 2 diabetes who fail to achieve glycemic control while receiving metformin monotherapy," the researchers wrote.
The Food and Drug Administration denied Boehringer Ingelheim (BI) approval in March, citing concerns about the facility where empagliflozin is to be manufactured. Two other SGLT2 inhibitors – canagliflozin (Invokana) and dapagliflozin (Farxiga) – have already been approved.
Eli Lilly and BI funded the study. Dr. Häring is an advisory board member with BI, and five coauthors were employed by the company.