Abstract：
AIMS:To compare insulin glargine 300 U/mL (Gla-300) with glargine 100 U/mL (Gla-100) in Japanese adults with uncontrolled type 2 diabetes on basal insulin and oral anti-hyperglycaemic drugs over 12 months. METHODS:EDITION JP 2 was a randomised, open-label, phase 3 study. Following a 6-month treatment period, participants continued receiving previously assigned once daily Gla-300 or Gla-100, plus oral anti-hyperglycaemic drugs, in a 6-month extension period. Glycaemic control, hypoglycaemia and adverse events were assessed. RESULTS:The 12-month completion rate was 88% for Gla-300 and 96% for Gla-100, with comparable reasons for discontinuation. Mean HbA1c decrease from baseline to month 12 was 0.3% in both groups. Annualised rates of confirmed (≤3.9mmol/L [≤70mg/dL]) or severe hypoglycaemia were lower with Gla-300 than Gla-100 (nocturnal [00:00-05:59h]: rate ratio 0.41; 95% confidence interval: 0.18 to 0.92; anytime [24h]: rate ratio 0.64; 95% confidence interval: 0.44 to 0.94). Cumulative number of hypoglycaemic events was lower with Gla-300 than Gla-100. Adverse event profiles were comparable between treatments. CONCLUSION:Over 12 months, Gla-300-treated participants achieved sustained glycaemic control and experienced less hypoglycaemia, particularly at night, versus Gla-100, supporting 6-month results.
journal_name
Diabetes Metabjournal_title
Diabetes & metabolismauthors
Terauchi Y,Koyama M,Cheng X,Sumi M,Riddle MC,Bolli GB,Hirose T,EDITION JP 2 study group.doi
10.1016/j.diabet.2017.03.001subject
Has Abstractpub_date
2017-10-01 00:00:00pages
446-452issue
5eissn
1262-3636issn
1878-1780pii
S1262-3636(17)30049-6journal_volume
43pub_type
杂志文章,多中心研究,随机对照试验abstract：BACKGROUND:Although the management of diabetes mellitus varies according to non medical factors, the influence of socioprofessional category has been not fully studied. This study compared the management of type 2 diabetes mellitus in craftsmen or tradesmen with professionals categories. METHODS:All claims to the Fren...
journal_title：Diabetes & metabolism
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