Abstract 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, HbA 1c 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 ≥1HbA 1c 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 HbA 1c 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.
Pscherer et al. (Tue,) studied this question.