Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve 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. K E Y W O R D Sglycaemic control, hypoglycaemia, insulin analogues, observational study, type 2 diabetes

Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study

“…However, there is a paucity of real-world comparative effectiveness research in European patient populations [ 26 ]. Non-comparative studies conducted in Europe have shown that switching to [ 27 – 29 ] or initiating [ 30 ] Gla-300 improves glycemic control, but the impact on hypoglycemia is unclear.…”

<p>Real-World Effectiveness of Insulin Glargine 300 Initiation in Switzerland</p>

“…The Toujeo-1 explored the real-world effectiveness of Gla-300 in adult patients with T2D uncontrolled on their previous OAD therapy with or without a Glucagon-Like Peptide1 Receptor Agonist (GLP-1 RA). 7 Investigators were general practitioners and specialists in internal medicine, endocrinology/diabetology. The Swiss cohort started Gla-300 treatment between November 2015 and December 2016 in 21 participating centers.…”

“…5,6 Toujeo-1 is a 12-month prospective real-world study to investigate the effectiveness and safety of Gla-300 in patients with T2D who were uncontrolled on oral antidiabetic drugs (OADs) ± Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA). Data for the pooled patients from Germany and Switzerland have been published recently, 7 but data specific for Switzerland are lacking. It was therefore the purpose of the present analysis to provide Switzerland specific data and to put these data into perspective with the ones in the overall Toujeo-1 dataset.…”

Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis

“…in whom glycaemic targets have not been achieved) initiated on Gla-300 therapy, and had to have a duration of at least 24 weeks and individual participant-level data available for both efficacy and safety outcomes [16]. In the present analysis, 14 trials conducted between June 2015 and December 2018 were pooled (Table 1), ten of which are already published [17][18][19][20][21][22][23][24][25][26][27]. The rationale, methodology and a detailed description of the variables have been already provided in the published protocol of the REALI project [16].…”