Study design: A total of 686 patients with type 2 diabetes participated in a double-blind, active-controlled study to evaluate
the efficacy and safety of empagliflozin 10 mg or 25 mg in combination with
linagliptin 5 mg, compared to the individual components. Patients with type 2 diabetes inadequately
controlled on at least 1500 mg of metformin per day entered a single-blind placebo run-in period for 2 weeks.
At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10.5% were randomized
1:1:1:1:1 to 1 of 5 active-treatment arms of empagliflozin 10 mg or 25 mg,
linagliptin 5 mg, or linagliptin 5 mg in combination with
10 mg or 25 mg empagliflozin as a fixed-dose combination tablet.
The primary endpoint was A1C change from baseline at 24 weeks. Achievement of A1C target <7.0%, FPG change from baseline,
and weight change from baseline at 24 weeks were key secondary endpoints.3