Current NICE guidance on the management of type 2 diabetes recommends initial therapy with metformin alone, or in combination with a sulfonylurea. Where either drug is not tolerated or contra-indicated, a DPP-4 inhibitor such as sitagliptin or vildagliptin may be added as second-line agent.
Patients were randomised to receive either 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 HbA1c at week 24. The study was powered to detect a difference in HbA1c reduction between the combination of empagliflozin and linagliptin and the individual components assuming a common SD of 1.05% and using a significance level of 2.5% (one-sided).
At week 24, reductions in HbA1c were 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).