New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1)

被引:73
|
作者
Matsuhisa, M. [1 ]
Koyama, M. [2 ]
Cheng, X. [3 ]
Takahashi, Y. [2 ]
Riddle, M. C. [4 ]
Bolli, G. B. [5 ]
Hirose, T. [6 ]
机构
[1] Univ Tokushima, Tokushima 7708503, Japan
[2] Sanofi, Tokyo, Japan
[3] Sanofi, Beijing, Peoples R China
[4] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[5] Univ Perugia, Sch Med, I-06100 Perugia, Italy
[6] Toho Univ, Sch Med, Tokyo, Japan
关键词
basal insulin; glycaemic control; insulin analogues; phase III study; randomised trial; type; 1; diabetes; GLYCEMIC CONTROL; PEOPLE; MELLITUS; DEGLUDEC; MANAGEMENT; EFFICACY; PROVIDES; UNITS/ML;
D O I
10.1111/dom.12619
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aim: To compare efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of insulin glargine 100 U/ml (Gla-100) in Japanese adults with type 1 diabetes. Methods: The EDITION JP 1 study (NCT01689129) was a 6-month, multicentre, open-label, phase III study. Participants (n=243) were randomized to Gla-300 or Gla-100 while continuing mealtime insulin. Basal insulin was titrated with the aim of achieving a fasting self-monitored plasma glucose target of 4.4-7.2 mmol/l. The primary endpoint was change in glycated haemoglobin (HbA1c) over 6months. Safety measures included hypoglycaemia and change in body weight. Results: Gla-300 was non-inferior to Gla-100 for the primary endpoint of HbA1c change over the 6-month period {least squares [LS] mean difference 0.13% [95 % confidence interval (CI) -0.03 to 0.29]}. The annualized rate of confirmed (<= 3.9 mmol/l) or severe hypoglycaemic events was 34 % lower with Gla-300 than with Gla-100 at night [rate ratio 0.66 (95% CI 0.48-0.92)] and 20% lower at any time of day [24 h; rate ratio 0.80 (95% CI 0.65-0.98)]; this difference was most pronounced during the first 8 weeks of treatment. Severe hypoglycaemia was infrequent. The basal insulin dose increased in both groups (month 6 dose: Gla-300 0.35 U/kg/day, Gla-100 0.29 U/kg/day). A between-treatment difference in body weight change over 6months favouring Gla-300 was observed [LS mean difference -0.6 kg (95 % CI -1.1 to -0.0); p=0.035]. Adverse event rates were comparable between the groups. Conclusions: In Japanese adults with type 1 diabetes using basal plus mealtime insulin, less hypoglycaemia was observed with Gla-300 than with Gla-100, particularly during the night, while glycaemic control did not differ.
引用
收藏
页码:375 / 383
页数:9
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