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Aims: This study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI‐supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla‐300) in adults with inadequately controlled type 2 diabetes (T2D). Materials and methods: This was a non‐interventional, multicentre, prospective 12‐month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non‐Gla‐300 BOT regimen, after the physician had decided to switch the BI to Gla‐300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target. Results: In total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla‐300 treatment (FAS‐M12). The main previous BI was insulin glargine 100 U/ml (Gla‐100; 47.2%). Twelve months after switching to Gla‐300, 27.0% of FAS‐M12 participants achieved the FPG target and 44.8% their individualized HbA1c target. The greatest FPG target achievements were seen in previous Gla‐100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). The mean FPG decreased by −36.3 ± 51.2 mg/dl to 135.5 ± 36.9 mg/dl and mean HbA1c by −0.79 ± 1.01% to 7.45 ± 0.94%. Symptomatic and nocturnal hypoglycaemia incidence significantly decreased over 12 months of Gla‐300 treatment. Body weight remained unchanged. Conclusions: Switching the BI to Gla‐300 in a BOT regimen improved metabolic control and treatment satisfaction in a substantial proportion of patients with T2D and inadequate target achievement within 12 months in clinical practice with a decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla‐300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). Materials and Methods: This non‐interventional, multi‐centre, prospective 52‐week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla‐300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target. Results: Of 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla‐300 treatment. Twelve months after starting Gla‐300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by −51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla‐300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged. Conclusions: Starting a BOT regimen with Gla‐300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia. [ABSTRACT FROM AUTHOR]