2331-PUB: Effectiveness of Insulin Glargine 300 units/mL in Treating Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic (TOPAZ Study)

Objective: To evaluate the clinical effectiveness of Gla-300 units/mL (Gla-300) in the treatment of patients with type 2 diabetes (T2DM) uncontrolled by basal insulin in real-life clinical settings in the Czech Republic (TOPAZ study).

Methods: TOPAZ was a prospective, multi-centric, non-interventional, 6-month study. Of the 312 patients screened, 289 were evaluated at month 6. The primary objective was the change of HbA1c after 6 months. The proportion of patients with HbA1c <7% DCCT (<53 mmol/mol), and those with a decrease of at least 0.5% of HbA1c at month 6, change in FPG, body weight and insulin dose at months 3 and 6 were analysed as secondary objectives. Incidence of hypoglycaemia, adverse events and patient treatment satisfaction (DTSQ) were also assessed.

Results: HbA1c decreased significantly after 6 months (mean change 0.9 ± 1.1% DCCT [-9.9 ± 11.6 mmol/mol], p < 0.0001). HbA1c target < 7% DCCT was achieved in 17.6% of patients, 66.1% of patients showed mean HbA1c decrease of -1.5 ± 0.8%. At month 6, FPG decreased (mean change from baseline -1.8 ±3.1 mmol/L) as well as the incidence of hypoglycaemia decreased by 49% (p ˂ 0.0001) while no weight gain was observed. No significant safety signals were identified. Patients reported significantly better satisfaction with the treatment with Gla-300 (p < 0.0001).

Conclusion: In a real-world setting, switching to Gla-300 in T2DM patients uncontrolled with any other basal insulin was associated with improved glycemic control and reduced risk of hypoglycaemia without weight gain, while patients′ satisfaction with treatment increased.