门冬氨酸胰岛素
医学
脱胶胰岛素
胰岛素
内科学
内分泌学
糖尿病
胰岛素detemir
1型糖尿病
甘精胰岛素
低血糖
作者
Edward Franek,Martin Haluzı́k,Silvija Canecki Varžić,Mehmet Sargın,Stanislava Macura,Jeppe Zacho,Jens Sandahl Christiansen
摘要
Abstract Aim To evaluate the efficacy and safety of twice‐daily insulin degludec/insulin aspart vs. twice‐daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. Methods In this 26‐week, multinational, open‐label, controlled, two‐arm, parallel‐group, treat‐to‐target trial, participants [mean (± sd ) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA 1c 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m 2 ) were randomized (1:1) to insulin degludec/insulin aspart ( n = 197) or biphasic insulin aspart 30 ( n = 197), administered with breakfast and the main evening meal, titrated to a self‐monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. Results The mean HbA 1c was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non‐inferiority margin (estimated treatment difference 0.02%; 95% CI −0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference −1.00 mmol/l; 95% CI −1.4, −0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. Conclusions Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long‐term glycaemic control, with superior reductions in FPG , and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin‐naïve.
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