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

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 À36.3 ± 51.2 mg/dl to 135.5 ± 36.9 mg/dl and mean HbA1c by À0.79 ± 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.

Trends in basal insulin prescribing in older adults with chronic kidney disease in Ontario, Canada: A population‐based analysis from 2010 to 2020

“…Degludec and glargine-300 provide stable glycaemic control with once-daily dosing, improve time in range, 27 and reduce hypoglycaemia compared with earlier-generation basal insulin analogues. [28][29][30] Interestingly, our study also illustrates that, in recent years, both prevalent and incident prescriptions for basal insulins have declined in older adults. Part of this might be explained by the increasing number of new oral and injectable medications available for people with type 2 diabetes.…”

“…Moreover, there are notable benefits with the use of newer analogues. Degludec and glargine‐300 provide stable glycaemic control with once‐daily dosing, improve time in range, 27 and reduce hypoglycaemia compared with earlier‐generation basal insulin analogues 28‐30 …”

Glycaemic Control in People with Type 2 Diabetes Mellitus Switching from Basal Insulin to Insulin Glargine 300 U/ml (Gla-300): Results from the REALI Pooled Database

“…However, in the present analysis, the direction of changes in hypoglycaemia risk throughout the 24-week Gla-300 treatment period as well as betweengroup comparisons seems to be maintained, thereby lending confidence to the data reported herein. Of note, symptomatic and severe hypoglycaemias occurring at any time of the day (24 h) and during the night were the only types of hypoglycaemic events that were consistently reported across the individual pooled studies [9][10][11][12][13][14][15][16][17][18][19]. Other hypoglycaemic events (e.g., asymptomatic hypoglycaemia, symptomatic confirmed hypoglycaemia, daytime hypoglycaemia) were not reported across all individual studies and were hence not included in the REALI analysis.…”

“…This REALI analysis included pooled data from 11 multicentre, prospective, open-label studies of a minimum duration of 24 weeks conducted between June 2015 and April 2019 in Germany, Austria, Switzerland, the Netherlands, Spain, France, the Czech Republic, Greece, Poland, Denmark, Slovenia, Slovakia, Croatia, the UK, Belgium, Serbia, Bulgaria, and Hungary [9][10][11][12][13][14][15][16][17][18][19]. The methodology of the REALI project and previous analyses from the REALI database have been presented elsewhere [20][21][22].…”

“…In the EDITION phase III clinical trial programme performed in a large population with a broad clinical spectrum of T2DM, patients who switched to Gla-300 from another BI, either Gla-100 or NPH insulin, demonstrated comparable glycaemic control with consistently fewer hypoglycaemic events at any time of the day and nocturnally compared with those who switched to Gla-100 [7]. Real-world evidence concerning switching to Gla-300 has also been encouraging, with real-life prospective studies from different countries across Europe showing that a direct switch to Gla-300 from other BIs resulted in improved glycaemic control and a reduced risk of hypoglycaemia without weight gain [8][9][10][11][12][13]. However, there are very limited prospective real-world data evaluating the switch from NPH insulin to Gla-300, with only one published study from Poland prospectively assessing the effectiveness of switching from NPH insulin to Gla-300 in a total of 469 people with T2DM [8].…”