Clinical research of insulin glargine U300 in type 1 diabetes mellitus patients with frequent hypoglycaemia: real-world experience.

Introduction: We aimed to see whether insulin glargine U300 can provide better blood glucose control while reducing hypoglycaemia in a more homogeneous population compared to previous studies.

Material and methods: The retrospective study included type 1 diabetes mellitus (T1DM) patients with frequent hypoglycaemia. For evaluation of fasting blood glucose, haemoglobin glycated (HbA_1c) and weight at 6 months and 12 months (final), observation windows of 120-240 days (4-8 months) and 240-480 days (9-16 months) after insulin glargine U300 initiation, respectively, were permitted. Mean follow-up time was 12 months. Hypoglycaemia was defined as blood glucose level < 70 mg/dl, either symptomatic or asymptomatic, measured in hospital or at home.

Results: Forty-four patients were included in the study, and 35 patients completed the study - 20 (57.1%) females and 15 (42.9%) males, with a mean age of 24.1 ±6.6 years. Mean body mass index was 24.4 ±7.4 kg/m². A significant decrease was not found between baseline and HbA_1c values at 6 months (p = 0.199), but a significant decrease was found in the final period (between 9-16 months) (p = 0.025). Hypoglycaemic events occurred in all patients (100%) before using insulin glargine U300, while the incidence of hypoglycaemic events gradually decreased to 74.3%, 68.6%, and 68.6% between months 1-3, 3-6, and 6-9, respectively. Of the 26 patients who declared their level of satisfaction, 23 (88.5%) were satisfied, 2 (7.7%) indicated that there was no significant difference, and 1 (3.8%) patient was unsatisfied.

Conclusions: Over 9-16 months of follow-up, insulin glargine U300 led to a significant reduction not only of HbA_1c levels but also of the frequency of hypoglycaemia, and also yielded high satisfaction rates.