Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12‐month trial including 6‐month extension

• DOI: 10.1111/dom.12532
• Publication Date: 2015-07-14T14:57:27Z
• Authors: H. Yki‐Järvinen; R. M. Bergenstal; G. B. Bolli; M. Ziemen; M. Wardecki; I. Muehlen‐Bartmer; M. Maroccia; M. C. Riddle
• Keywords: Basal (medicine)

Aims To compare the efficacy and safety of new insulin glargine 300 U/ml ( Gla ‐300) with 100 ‐100) over 12 months treatment in people type 2 diabetes using basal oral antihyperglycaemic drugs OADs ). Methods EDITION NCT01499095 ) was a randomized, 6‐month, multicentre, open‐label, two‐arm, phase IIIa study investigating once‐daily ‐300 versus ‐100, plus (excluding sulphonylureas), 6‐month extension. Results Similar numbers participants each group completed [ ‐300, 315 (78%); 314 (77%)]. The reduction glycated haemoglobin maintained for both treatments: least squares LS mean (standard error) change from baseline −0.55 (0.06)% G la‐300 −0.50 ‐100; difference −0.06 [95% confidence interval CI −0.22 to 0.10)%]. A significant relative 37% annualized rate nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia observed compared ‐100: ratio 0.63 [(95% 0.42–0.96); p = 0.031], fewer experienced ≥1 event [relative risk 0.84 (95% 0.71–0.99)]. Severe infrequent. Weight gain significantly lower than ‐100 −0.7 −1.3 −0.2) kg; 0.009]. Both treatments were well tolerated similar pattern adverse events (incidence 69 60% groups). Conclusions In treated non‐sulphonylurea , glycaemic control sustained months, less group.