Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: A 26-week, randomised, treat-to-target trial

Abstract

Aims: Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of IDeg and IAsp. This pan-Asian, 26-week trial investigated efficacy and safety of IDegAsp vs biphasic insulin aspart 30 (BIAsp 30) in Asian adults with type 2 diabetes (T2DM), inadequately controlled on once-or twice-daily (BID) basal, premixed or self-mixed insulin. Methods: Participants (mean age 59.8 years, HbA1c 8.4%, FPG 7.9 mmol/L, BMI 25.4 kg/m2) were randomised 2: 1 to BID IDegAsp (n = 282) or BIAsp 30 (n = 142) and continued existing metformin treatment. Insulins were administered with breakfast and main evening meal, titrated to a pre-breakfast and pre-main evening meal self-measured plasma glucose target of 4-5 mmol/L. Results: IDegAsp achieved the primary endpoint of non-inferiority to BIAsp 30 for mean change in HbA1c (estimated treatment difference [ETD] IDegAsp-BIAsp 30: 0.05% points [95% CI +/- 0.10; 0.20]). IDegAsp was superior in lowering fasting plasma glucose (FPG) (ETD +/- 1.06 mmol/L, 95% CI +/- 1.43; +/- 0.70, p < 0.001), and resulted in a lower final mean daily insulin dose (0.79 U/kg vs 0.99 U/kg, estimated rate ratio [RR] 0.79, 95% CI 0.73; 0.85, p < 0.0001).Rates of overall confirmed and severe hypoglycaemia were similar between treatments, while rate of nocturnal confirmed hypoglycaemia was numerically (p = ns) lower with IDegAsp. During the maintenance period there was a trend (p = ns) towards lower hypoglycaemia rates for IDegAsp. Conclusion: In Asian adults with T2DM, IDegAsp BID effectively improves long-term glycaemic control, and compared to BIAsp 30, provides superior reductions in FPG with a lower dose, and numerically less nocturnal hypoglycaemia. (C) 2014 The Authors. Published by Elsevier Ireland Ltd.