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Introduction: 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-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 Results: HbA1c decreased significantly after 6 months (mean change 0.9% ± 1.1% DCCT [−9.9 ± 11.6 mmol/mol], p −1.8 ± 3.1 mmol/L) as well as the incidence of hypoglycemia decreased by 49% (p 0.0001) while no weight gain was observed. No significant safety signals were identified. Conclusion: 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.
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Prázný et al. (2020) studied this question.
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