Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300?U/mL in People with Type?1 Diabetes on Basal–Bolus Insulin: Phase?4 OPTIMIZE Study

摘要

IntroductionOPTIMIZE evaluated the efficacy, safety and treatment satisfaction of insulin glargine 300?U/mL once daily (Gla-300 OD) in people with type?1 diabetes mellitus (T1DM) previously uncontrolled on basal insulin twice daily (BID) as part of basal–bolus therapy.MethodsOPTIMIZE was a 28-week, prospective, interventional, single-arm phase?4 trial in adults with T1DM. At baseline, basal insulin BID treatment was switched to Gla-300 OD titrated to a fasting self-monitored blood glucose target of 4.4–7.2?mmol/L (80–130?mg/dL). The primary endpoint was the mean glycated haemoglobin (HbA 1c ) change from baseline to week?24. Secondary endpoints included self-monitored blood glucose, fasting-plasma glucose, hypoglycaemia and patient-reported outcomes including the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs).ResultsSwitching to Gla-300 OD significantly improved mean HbA 1c (8.54% at baseline and 8.27% at week?24 [last observation carried forward, N =?94, p ?0.0001]; mean difference 0.27% [95% CI 0.15, 0.40]). There was a statistically significant decrease in fasting self-monitored blood glucose during the study (analysis of variance for repeated measures, p =?0.014; N =?72). Eight-point self-monitored blood glucose was significantly improved between baseline and week?24 for post-breakfast ( p =?0.009), post-dinner ( p =?0.009) and bedtime ( p =?0.049) values. The study did not allow for any significant effects on confirmed and/or severe hypoglycaemia at the ≤?3.9?mmol/L [≤?70?mg/dL] or ?3.0?mmol/L [?54?mg/dL] blood glucose cut-offs to be observed. Statistically significant improvements were observed in DTSQs total scores from baseline (24.1) to week?24 (29.4, p ?0.0001).ConclusionsA basal–bolus regimen including Gla-300 OD was associated with improvements in HbA 1c and treatment satisfaction in people with uncontrolled T1DM previously receiving basal–bolus insulin including a basal insulin BID analogue.