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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
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.1
References: 1. DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015;38(3):384-393. 2. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
References: 1. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc. 2. American Diabetes Association. Standards of Medical Care in Diabetes—2020. Diabetes Care. 2020;43(suppl 1):S1-S212. 3. DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015;38(3):384-393.
In the modified intent-to-treat analysis of the primary endpoint,: the adjusted mean A1C change from baseline for TRIJARDY XR 10/5/≥1500 mg was -1.1% (n=135); TRIJARDY XR 25/5/≥1500 mg, -1.2% (n=133); linagliptin 5 mg, -0.7% (n=128); empagliflozin 10 mg, -0.7% (n=137); empagliflozin 25 mg, -0.6% (n=139). TRIJARDY XR vs individual components, P<0.0001.1
References: 1. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
Reference: 1. American Diabetes Association. Standards of Medical Care in Diabetes—2020. Diabetes Care. 2020;43(suppl 1):S1-S212.
