One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in @entity1 with type 2 XXXX using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension.

@entity1 @entity9984 @entity4051 @entity6 @entity413
AIMS: To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml ( @entity9984 -300) versus glargine 100 U/ml ( @entity9984 -100) in @entity1 with @entity6 ( @entity6 ) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. METHODS: EDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. @entity1 completing the initial 6-month treatment period continued to receive @entity9984 -300 or @entity9984 -100, as previously randomized, once daily for a further 6-month open-label extension phase. Changes in glycated haemoglobin (HbA1c) and fasting plasma @entity413 concentrations, insulin dose, hypoglycaemic events and body weight were assessed. RESULTS: Of 807 @entity1 enrolled in the initial phase, 89% (359/404) assigned to @entity9984 -300 and 88% (355/403) assigned to @entity9984 -100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c: @entity9984 -300, 7.24%; @entity9984 -100, 7.42%), with more sustained @entity4051 c reduction for @entity9984 -300 at 12 months: least squares mean difference @entity9984 -300 vs @entity9984 -100: HbA1c -0.17 [95% confidence interval (CI) -0.30 to -0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for @entity9984 -300 and 0.90 U/kg for @entity9984 -100. Lower percentages of @entity1 had >= 1 confirmed [ <=3.9 mmol/l ( <=70 mg/dl)] or severe hypoglycaemic event with @entity9984 -300 than @entity9984 -100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89-0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75-0.94)], while the annualized rates of such hypoglycaemic events were similar. No between-treatment differences in adverse events were apparent. CONCLUSION: During 12 months of treatment of @entity6 requiring basal and meal-time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with @entity9984 -300 than with @entity9984 -100. The mean basal insulin dose was higher with @entity9984 -300 compared with @entity9984 -100, but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments.
