NewInsulinGlargine 300 Units / mL Versus Glargine 100 Units / mL in People With Type 1 Diabetes : A Randomized , Phase 3 a , Open - Label Clinical Trial

Participants (n = 549) were a mean age of 47 years, had a duration of diabetes of 21 years, and a BMI of 27.6 kg/m. The change in HbA1c (primary end point; baseline 8.1%) was equivalent in the two treatment-groups (difference, 0.04% [95% CI 20.10 to 0.19]) (0.4 mmol/mol [21.1 to 2.1]), and Gla-300 was thus noninferior. Similar results with wider 95% CIs were found for morning and evening injection times and for prebreakfast self-measured plasma glucose (SMPG) overall. Results were also similar for Gla-300 when morning and evening injection time was compared, including overlapping 8-point SMPG profiles. Hypoglycemia did not differ, except for the first 8 weeks of the study, when nocturnal confirmed or severe hypoglycemia was lower with Gla-300 (risk ratio 0.69 [95% CI 0.53– 0.91]). Hypoglycemia with Gla-300 did not differ by time of injection. The basal insulin dose was somewhat higher at 6 months for Gla-300. The adverse event profile did not differ andwas independent of the Gla-300 time of injection.Weight gain was lower with Gla-300.