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Efficacy and safety of once‐daily insulin degludec/insulin aspart compared with once‐daily insulin glargine in participants with Type 2 diabetes: a randomized, treat‐to‐target study
Author(s) -
Kumar S.,
Jang H. C.,
Demirağ N. G.,
Skjøth T. V.,
Endahl L.,
Bode B.
Publication year - 2017
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13125
Subject(s) - medicine , insulin glargine , insulin aspart , evening , insulin , type 2 diabetes , insulin degludec , randomized controlled trial , type 1 diabetes , diabetes mellitus , endocrinology , meal , hypoglycemia , physics , astronomy
Aims To investigate, in a 26‐week, open‐label, randomized, treat‐to‐target trial, the efficacy and safety of insulin degludec/insulin aspart ( ID egAsp) once daily vs insulin glargine ( IG lar) once daily in adults with Type 2 diabetes, inadequately controlled on basal insulin. Methods Participants were randomized (1:1) to ID egAsp once daily or IG lar once daily in combination with existing oral antidiabetic drugs. ID egAsp once daily was administered with the main evening meal or the largest meal of the day (agreed at baseline); dosing time was maintained throughout the trial. Participants titrated their insulin dose weekly to a mean pre‐breakfast self‐measured plasma glucose target [3.9–4.9 mmol/l (70–89 mg/dl)]. Results ID egAsp once daily was non‐inferior to IG lar once daily in reducing HbA 1c after 26 weeks [mean estimated treatment difference ID egAsp once daily − IG lar once daily: −0.03% (95% CI −0.20, 0.14)]. The evening meal glucose increment was significantly lower with ID egAsp once daily vs IG lar once daily [estimated treatment difference ID egAsp once daily − IG lar once daily: −1.32 mmol/l (95% CI −1.93, −0.72); P < 0.05]. The overall confirmed hypoglycaemia rate was higher with ID egAsp once daily (estimated rate ratio 1.43; 95% CI 1.07, 1.92; P < 0.05). The rate of nocturnal hypoglycaemia did not significantly differ between the ID egAsp and IG lar groups [estimated rate ratio 0.80 (95% CI 0.49, 1.30); not significant]. Conclusions In participants with Type 2 diabetes inadequately controlled on basal insulin, ID egAsp once daily improved glycaemic control and was non‐inferior to IG lar once daily. ID egAsp led to higher rates of overall hypoglycaemia than IG lar, with no significant difference in rates of nocturnal hypoglycaemia.