Guaranteeing the safety performance of chemical process units is the premise for the safety production of chemical enterprises.Only to have the system safety management of the whole life cycle of the process units can...Guaranteeing the safety performance of chemical process units is the premise for the safety production of chemical enterprises.Only to have the system safety management of the whole life cycle of the process units can operate the process systems under the state of controllable risk.展开更多
<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Guaranteeing the safety performance of chemical process units is the premise for the safety production of chemical enterprises.Only to have the system safety management of the whole life cycle of the process units can operate the process systems under the state of controllable risk.
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>