Diabetes, obesity & metabolism · 2026
Efficacy and safety of switching basal insulin to insulin glargine 300 U/mL in individuals with inadequately controlled type 2 diabetes on advanced insulin therapies: The Toujeo-Neo T2DM study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Pscherer Stefan, Fritsche Andreas, Anderten Helmut, Pegelow Katrin, Han Henry Y, Pfohl Martin, Seufert Jochen
Аннотация
AIMS: This real-world study evaluated the effectiveness and safety of switching basal insulin (BI) to insulin glargine 300 U/mL (Gla-300) in adults with inadequately controlled type 2 diabetes mellitus (T2DM), previously receiving basal-supported oral therapy plus prandial insulin (BOTplus) or multiple (≥3) daily injections (MDI) of short-acting insulins.
MATERIALS AND METHODS: This non-interventional, multicentre, open-label, prospective 12-month study in Germany included adult participants (≥18 years) with T2DM, HbA1c between 7.5% and 10.0%, and fasting plasma glucose (FPG) >130 mg/dL (>7.2 mmol/L). The participants were switched from non-Gla-300 BOTplus or MDI regimen (including Gla-100, IDet, IDeg, or NPH) to Gla-300. The primary endpoint was the duration of glycaemic target achievement, defined as the time between ≥2 FPG values ≤110 mg/dL (≤6.1 mmol/L) or ≥1HbA1c value below the predefined target.
RESULTS: Of 1217 participants, 582 completed the documentation of the 12-month Gla-300 treatment (FAS2-M12). Target achievement with Gla-300 was reported for 280/582 FAS2-M12 participants (48.1%). The median response duration was 295 days (95% CI: 226, 381). The mean (±SD) change in HbA1c and FPG from baseline was -0.56% (±1.08; n = 568) and -29.3 mg/dL or 1.63 mmol/L (±54.95; n = 540) at month 12, respectively (p < 0.0001). Numbers and incidence of hypoglycaemia were similar before starting Gla-300 therapy and at month 12. Body weight (100.1 kg ± 21.07; n = 571 at baseline) remained unchanged until month 12 (mean change: -0.0 kg ± 8.40; n = 513).
CONCLUSIONS: Switching BI to Gla-300 from a BOTplus or MDI regimen with prior insulin Gla-100, IDeg, IDet, or NPH improved glycaemic control in participants with inadequately controlled T2DM over 12 months without increasing hypoglycaemia risk or weight gain.
MATERIALS AND METHODS: This non-interventional, multicentre, open-label, prospective 12-month study in Germany included adult participants (≥18 years) with T2DM, HbA1c between 7.5% and 10.0%, and fasting plasma glucose (FPG) >130 mg/dL (>7.2 mmol/L). The participants were switched from non-Gla-300 BOTplus or MDI regimen (including Gla-100, IDet, IDeg, or NPH) to Gla-300. The primary endpoint was the duration of glycaemic target achievement, defined as the time between ≥2 FPG values ≤110 mg/dL (≤6.1 mmol/L) or ≥1HbA1c value below the predefined target.
RESULTS: Of 1217 participants, 582 completed the documentation of the 12-month Gla-300 treatment (FAS2-M12). Target achievement with Gla-300 was reported for 280/582 FAS2-M12 participants (48.1%). The median response duration was 295 days (95% CI: 226, 381). The mean (±SD) change in HbA1c and FPG from baseline was -0.56% (±1.08; n = 568) and -29.3 mg/dL or 1.63 mmol/L (±54.95; n = 540) at month 12, respectively (p < 0.0001). Numbers and incidence of hypoglycaemia were similar before starting Gla-300 therapy and at month 12. Body weight (100.1 kg ± 21.07; n = 571 at baseline) remained unchanged until month 12 (mean change: -0.0 kg ± 8.40; n = 513).
CONCLUSIONS: Switching BI to Gla-300 from a BOTplus or MDI regimen with prior insulin Gla-100, IDeg, IDet, or NPH improved glycaemic control in participants with inadequately controlled T2DM over 12 months without increasing hypoglycaemia risk or weight gain.