New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2)

Aims To compare the efficacy and safety of insulin glargine 300 U/ml (Gla‐300) with glargine 100 U/ml (Gla‐100) in Japanese people with type 2 diabetes using basal insulin plus oral antihyperglycaemic drug(s) [OAD(s)]. Methods The EDITION JP 2 study (NCT01689142) was a 6‐month, multicentre, open‐lab...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2016-04, Vol.18 (4), p.366-374
Main Authors: Terauchi, Y., Koyama, M., Cheng, X., Takahashi, Y., Riddle, M. C., Bolli, G. B., Hirose, T.
Format: Article
Language:English
Subjects:
Administration, Oral
Aged
basal insulin
Body mass index
Confidence intervals
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Delayed-Action Preparations - therapeutic use
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Dose-Response Relationship, Drug
Drug Resistance, Multiple
Drug Therapy, Combination - adverse effects
Evidence-based medicine
Female
Follow-Up Studies
glycaemic control
Glycated Hemoglobin - analysis
Hemoglobin
Humans
Hyperglycemia - prevention & control
Hypoglycemia
Hypoglycemia - chemically induced
Hypoglycemia - epidemiology
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Hypoglycemic Agents - therapeutic use
Insulin
insulin analogues
Insulin Detemir - adverse effects
Insulin Detemir - therapeutic use
Insulin Glargine - administration & dosage
Insulin Glargine - adverse effects
Insulin Glargine - therapeutic use
Japan - epidemiology
Male
Middle Aged
Original
phase III study
randomized trial
Risk
type 2 diabetes
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Summary:Aims To compare the efficacy and safety of insulin glargine 300 U/ml (Gla‐300) with glargine 100 U/ml (Gla‐100) in Japanese people with type 2 diabetes using basal insulin plus oral antihyperglycaemic drug(s) [OAD(s)]. Methods The EDITION JP 2 study (NCT01689142) was a 6‐month, multicentre, open‐label, phase III study. Participants (n = 241, male 61%, mean diabetes duration 14 years, mean weight 67 kg, mean body mass index 25 kg/m2, mean glycated haemoglobin (HbA1c) 8.02 %, mean basal insulin dose 0.24 U/kg/day) were randomized to Gla‐300 or Gla‐100, while continuing OAD(s). Basal insulin was titrated to target fasting self‐monitored plasma glucose 4.4−5.6 mmol/l. The primary efficacy endpoint was HbA1c change over 6 months. Safety endpoints included hypoglycaemia and weight change. Results Gla‐300 was non‐inferior to Gla‐100 for HbA1c reduction [least squares (LS) mean difference 0.10 (95% confidence interval [CI] −0.08, 0.27) %]. The mean HbA1c at month 6 was 7.56 and 7.52 % with Gla‐300 and Gla‐100, respectively. Nocturnal confirmed (≤3.9 mmol/l) or severe hypoglycaemia risk was 38% lower with Gla‐300 versus Gla‐100 [relative risk 0.62 (95% CI 0.44, 0.88)]; annualized rates were 55% lower at night [rate ratio 0.45 (95% CI 0.21, 0.96)] and 36% lower at any time [24 h; rate ratio 0.64 (95% CI 0.43, 0.96)]. Severe hypoglycaemia was infrequent. A significant between‐treatment difference in weight change favoured Gla‐300 [LS mean difference −1.0 (95% CI −1.5, −0.5) kg; p = 0.0003]. Adverse event rates were comparable between groups. Conclusions Japanese people with type 2 diabetes using basal insulin plus OAD(s) experienced less hypoglycaemia with Gla‐300 than with Gla‐100, while glycaemic control did not differ.
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.12618