<strong>Introduction:</strong><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> To evaluate the clinical effectiven...<strong>Introduction:</strong><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> 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). </span><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> TOPAZ was a prospective, multi-center, 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 < 7.0% 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 month 3 and 6 were analysed as secondary objectives. Incidence of hypoglycemia, adverse events and patient treatment satisfaction were also assessed. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> HbA1c decreased significantly after 6 months (mean change 0.9% ± 1.1% DCCT [</span></span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">−</span><span style="font-family:Verdana;">9.9 ± 11.6 mmol/mol], p < 0.0001). HbA1c target < 7.0% DCCT was achieved in 17.6% of patients, 66.1% of patients showed mean HbA1c decrease of 0.5% ± 0.8%. At month 6, FPG decreased (mean change from baseline </span><span style="font-family:Verdana;">−</span><span style="font-family:Verdana;">1.8 ± 3.1 mmol/L) as well as the incidence of hypoglycemia decreased by 49% (p <</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> 0.0001) while no weight gain was observed. No significant safety signals were ident</span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">ified. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> In a real-life setting, switching to Gla-300 in T2DM patients uncontrolled with other basal insulin was associated with improved glycemic control and reduced risk of hypoglycemia without weight gain, while patients’ satisfaction with treatment increased.</span></span></span></span>展开更多
文摘<strong>Introduction:</strong><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> 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). </span><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"> TOPAZ was a prospective, multi-center, 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 < 7.0% 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 month 3 and 6 were analysed as secondary objectives. Incidence of hypoglycemia, adverse events and patient treatment satisfaction were also assessed. </span><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"> HbA1c decreased significantly after 6 months (mean change 0.9% ± 1.1% DCCT [</span></span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">−</span><span style="font-family:Verdana;">9.9 ± 11.6 mmol/mol], p < 0.0001). HbA1c target < 7.0% DCCT was achieved in 17.6% of patients, 66.1% of patients showed mean HbA1c decrease of 0.5% ± 0.8%. At month 6, FPG decreased (mean change from baseline </span><span style="font-family:Verdana;">−</span><span style="font-family:Verdana;">1.8 ± 3.1 mmol/L) as well as the incidence of hypoglycemia decreased by 49% (p <</span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> 0.0001) while no weight gain was observed. No significant safety signals were ident</span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">ified. </span><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"> In a real-life setting, switching to Gla-300 in T2DM patients uncontrolled with other basal insulin was associated with improved glycemic control and reduced risk of hypoglycemia without weight gain, while patients’ satisfaction with treatment increased.</span></span></span></span>
