Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety. Issue 1 (24th September 2021)

• Record Type: Journal Article
• Authors: Seufert, Jochen; Wiesli, Peter; Fritsche, Andreas; Anderten, Helmut; Pegelow, Katrin; Pscherer, Stefan; Pfohl, Martin
• Is Part Of: Diabetes, obesity & metabolism. Volume 24:Issue 1(2022)
• Page Start: 72
• Page End: 81
• Publication Date: 2021-09-24
• Subjects: basal insulin -- hypoglycaemia -- insulin analogues -- insulin therapy -- observational study -- type 2 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14549
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: 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.