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Seufert, J.* ; Wiesli, P.* ; Fritsche, A. ; Anderten, H.* ; Pegelow, K.* ; Pscherer, S.* ; Pfohl, M.*

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.

Diabetes Obes. Metab., DOI: 10.1111/dom.14549 (2021)
Publ. Version/Full Text Research data DOI PMC
Open Access Gold (Paid Option)
Creative Commons Lizenzvertrag
AIMS: This study evaluated 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 adult people with inadequately controlled type 2 diabetes (T2D). MATERIALS AND METHODS: This non-interventional, multicentre, prospective 12-month study, conducted in Germany, Austria and Switzerland, documented people with T2D with an HbA1c between 7.5-10.0%, 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 fasting plasma glucose (FPG; ≤110 mg/dL) target. RESULTS: 1,194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla-300 treatment (FAS-M12). 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. Greatest FPG target achievements were seen in previous Gla-100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). 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 decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain.
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Publication type Article: Journal article
Document type Scientific Article
Corresponding Author
Keywords Basal Insulin ; Hypoglycaemia ; Insulin Analogues ; Insulin Therapy ; Observational Study ; Type 2 Diabetes; Hypoglycemia; Units/ml; Outcomes
ISSN (print) / ISBN 1462-8902
e-ISSN 1463-1326
Journal Diabetes, Obesity and Metabolism
Publisher Wiley
Publishing Place 111 River St, Hoboken 07030-5774, Nj Usa
Non-patent literature Publications
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research and Metabolic Diseases (IDM)
Grants Sanofi-Aventis Deutschland GmbH, Berlin, Germany