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Aims  Insulin glargine 300 U/mL ( G la‐300) offers a flatter pharmacodynamic profile than insulin glargine 100 U/mL ( G la‐100). We have compared these insulins over 1 year in people with type 1 diabetes ( T1DM ).    Methods   EDITION  4 was a 6‐month, multicentre, randomized, open‐label phase 3 study. People with  T1DM  who completed the 6 months continued randomized  G la‐300 or  G la‐100 once daily, morning or evening, for a further 6 months.    Results  Among 549 participants randomized, 444 completed the 12‐month study period ( G la‐300, 80%;  G la‐100, 82%). Mean HbA1c decreased similarly from baseline to month 12 in the 2 treatment groups (difference, 0.02 [95% CI, −0.13 to 0.17]) %‐units [0.2 (−1.5 to 1.9) mmol/mol]), to a mean of 7.86 %‐units (62.4 mmol/mol) in both groups. For morning vs evening injection, there was no difference in  HbA1c  change over 12 months for  G la‐100, but a significantly larger decrease in  HbA1c  was observed in the  G la‐300 morning group than in the  G la‐300 evening group (difference, −0.25 [−0.47 to −0.04] %‐units [−2.7 (−5.2 to −0.4) mmol/mol]). Mean glucose from the 8‐point  SMPG  profiles decreased from baseline, and was similar between the 2 treatment groups. Basal insulin dose was 20% higher with  G la‐300 than with  G la‐100, while hypoglycaemia event rates, analysed at night, over 24 hours, or according to different glycaemic thresholds, did not differ between treatment groups, regardless of injection time. Adverse event profiles did not differ between groups.    Conclusions  In  T1DM ,  G la‐300 provides glucose control comparable to that of  G la‐100, and can be given at any time of day.

diabetes, obesity and metabolism

Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes ( EDITION  4)