The EDITION program demonstrated similar efficacy with lower risk of hypoglycemia (HG) of insulin glargine U300 (Gla-300) compared to insulin glargine U100 in T2DM. Data prospectively collected on real world use of Gla-300 are still of scarce. This single-arm, non-interventional, observational study aimed to describe the effectiveness of Gla-300 in real world setting in people with advanced T2DM. Data on HbA1c, fasting BG, weight (BMI), insulin doses and HG were collected for 6 months in routine clinical care in Hungary from 229 people with T2DM (age: 60.9 years±10.4, diabetes duration:13.4 years±7.9, being on insulin for: 7.4 years±6.2, HbA1c: 8.9%±1.5, BMI: 32.5kg/m2±5.7 (mean±SD)) previously treated with human basal-bolus (BB) regime (NPH+regular insulin) who were switched to analogue BB with Gla-300 and insulin glulisine. Data on safety and efficacy were available for 217 (95%) and 189 (83%) patients, respectively. Reasons for switching were: uncontrolled diabetes (68%), HG (15%), combination of the two (17%). By Month 6, HbA1c decreased by 1.36% (-1.55; -1.17), (mean+95% CI), fasting BG by 47 mg/dl (-57; -37), (p<0.001 for both), while BMI decreased by 0.28 (-0.68; 0.13, NS). An HbA1c of 8.0%, the glycemic target for long term reimbursement for insulin analogues was achieved in 78% of the patients. Daily basal dose (U) was increased from 34.5 to 41.0, bolus dose remained the same (+0.13, (+0.3%)). From safety perspective, proportion of patients with documented (severe/non-severe) HG (BG≤70mg/dl) decreased from 44.2% to 27.6% (change in HG incidence: patients with HG within the preceding 3 months before switching vs. patients with HG during follow-up). The effectiveness of Gla-300 in routine clinical care was consistent with results from the EDITION program. When used concomitantly with glulisine, Gla-300 provided a clinically significant HbA1c reduction alongside with a decreased risk of hypoglycemia allowing 78% of patients to reach an HbA1c goal ≤8%.
T. Hidvegi: None. P. Stella: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi.