Effectiveness and safety of insulin glargine 300?U/mL in insulin-naive patients with type 2 diabetes after failure of oral therapy in a real-world setting.

ABSTRACT: 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.

SUBMITTER: Pfohl M 

PROVIDER: S-EPMC7187365 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature