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A randomized, open‐label, multicentre, parallel‐controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral antidiabetic drugs: The merit study
Author(s) -
Guo Lixin,
Chen Li,
Chang Baocheng,
Yang Liyong,
Liu Yu,
Feng Bo
Publication year - 2018
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13454
Subject(s) - metformin , medicine , type 2 diabetes , diabetes mellitus , endocrinology , clinical endpoint , insulin , randomized controlled trial
Aim To confirm non‐inferiority of biphasic insulin aspart 30 (BIAsp 30) plus metformin to BIAsp 30 in lowering glycated haemoglobin (HbA1c) in Chinese patients with inadequately controlled type 2 diabetes using oral antidiabetic drugs. Materials and methods In this 16‐week, prospective, randomized, open‐label, multicentre, parallel‐controlled study, patients aged 18‐79 years with HbA1c ≥7% were randomized to BIAsp 30 plus metformin ( n = 130) or BIAsp 30 ( n = 127). Initially, 500 mg metformin was administered twice daily and BIAsp 30 was administered at 0.2‐0.3 U/kg/d. Changes in HbA1c % from baseline to week 16 as well as secondary and safety endpoints were assessed. Results In total, 83.66% of patients in the BIAsp 30 plus metformin ( n = 110) and the BIAsp 30 ( n = 105) groups completed the study. Mean (±standard deviation) change in HbA1c from baseline to endpoint was −1.74 ± 1.64% and −1.32 ± 2.05% with BIAsp 30 plus metformin and BIAsp 30, respectively. Least squares mean treatment difference was −0.67% (95% CI, −1.06; −0.28). The upper limit of the 95% CI was <0.4 (non‐inferiority margin). A significantly higher proportion of individuals reached HbA1c <7% with BIAsp 30 plus metformin than with BIAsp 30 (53.15% vs 35.19%; P = 0.0074). At endpoint, daily BIAsp 30 dose ( P < 0.001) and weight gain were significantly lower ( P < 0.05) in the BIAsp 30 plus metformin group compared with the BIAsp 30 group. No between‐group differences in number of hypoglycaemic events were observed. Conclusion BIAsp 30 plus metformin was non‐inferior to BIAsp 30 in safely reducing HbA1c in this study.