TITLE:
Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic
AUTHORS:
Martin Prázný, Milan Flekač, Petr Jelínek, Jana Mašková
KEYWORDS:
Fasting Plasma Glucose, Glycated Hemoglobin, Hypoglycemia, Insulin Glargine (Gla-300 Units/Ml), Real Life Data, Type 2 Diabetes (T2DM)
JOURNAL NAME:
Journal of Diabetes Mellitus,
Vol.10 No.3,
June
23,
2020
ABSTRACT: 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.