AIMS: To compare the efficacy and safety of insulin glargine 300 U/ml ( @entity9984 -300) with glargine 100 U/ml ( @entity9984 -100) in Japanese @entity1 with type 2 @entity6 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. @entity1 (n = 241, male 61%, mean @entity6 duration 14 years, mean weight 67 kg, mean body mass index 25 kg/m(2) , mean glycated haemoglobin (HbA1c) 8.02 %, mean basal insulin dose 0.24 U/kg/day) were randomized to @entity9984 -300 or @entity9984 -100, while continuing OAD(s). Basal insulin was titrated to target fasting self-monitored plasma @entity413 4.4-5.6 mmol/l. The primary efficacy endpoint was @entity4051 c change over 6 months. Safety endpoints included hypoglycaemia and weight change. RESULTS: @entity9984 -300 was non-inferior to @entity9984 -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 @entity9984 -300 and @entity9984 -100, respectively. Nocturnal confirmed ( <=3.9 mmol/l) or severe hypoglycaemia risk was 38% lower with @entity9984 -300 versus @entity9984 -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 @entity9984 -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 @entity1 with type 2 @entity6 using basal insulin plus OAD(s) experienced less hypoglycaemia with @entity9984 -300 than with @entity9984 -100, while glycaemic control did not differ.

New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese @entity1 with type 2 @entity6 using basal insulin and oral antihyperglycaemic drugs: XXXX control and hypoglycaemia in a randomized controlled trial (EDITION JP 2).

@entity1 :: ('9606', 'Species') :: ['Participants', 'people'] @entity9984 :: ('CHEBI:28661', 'Chemical') :: ['Gla'] @entity4051 :: ('3039', 'Gene') :: ['HbA1'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity413 :: ('MESH:D005947', 'Chemical') :: ['glucose']
@entity413 :: (MESH:D005947,Chemical) :: ['glucose']
