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OBJECTIVETo evaluate the efficacy and safety of combinations of empagliflozin/linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. RESEARCH DESIGN AND METHODSSubjects were randomized to a combination of empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 141), empagliflozin 10 mg (n = 140), or linagliptin 5 mg (n = 132) as add-on to metformin for 52 weeks. The primary end point was change from baseline in HbA 1c at week 24. (27.6 mmol/mol [0.7]) with linagliptin 5 mg (P < 0.001 for all comparisons). In these groups, respectively, 61.8, 57.8, 32.6, 28.0, and 36.1% of subjects with baseline HbA 1c ‡7% ( ‡53 mmol/mol) had HbA 1c <7% (<53 mmol/mol) at week 24. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across treatment arms (68.6-73.0%), with no hypoglycemic AEs requiring assistance. RESULTS At week 24, reductions in CONCLUSIONSCombinations of empagliflozin/linagliptin as second-line therapy for 52 weeks significantly reduced HbA 1c compared with the individual components and were well tolerated.

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The addition of linagliptin 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin resulted in a significant and clinically meaningful improvement in glycaemic control without weight gain or increased risk of hypoglycaemia.

OBJECTIVETo evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes. RESEARCH DESIGN AND METHODSSubjects not receiving antidiabetes therapy for ‡12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg (n = 135) for 52 weeks. The primary end point was change from baseline in HbA 1c at week 24. % (27.3 [0.7] mmol/mol), respectively. Reductions in HbA 1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects with baseline HbA 1c ‡7% ( ‡53 mmol/mol) reached HbA 1c <7% with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across groups (68.9-81.5%), with no confirmed hypoglycemic AEs. RESULTS Mean CONCLUSIONSReductions from baseline in HbA 1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.Empagliflozin is a potent and selective sodium-glucose cotransporter 2 (SGLT2) inhibitor (1) approved for the treatment of type 2 diabetes. Empagliflozin reduces renal glucose reabsorption, thereby increasing urinary glucose excretion, leading to a reduction in plasma glucose levels in subjects with type 2 diabetes in an insulinindependent manner (2). In a phase 3 trial in subjects with type 2 diabetes,