Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F20%3A10419905" target="_blank" >RIV/00216208:11110/20:10419905 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/20:10419905
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=dkrOrVUBa9" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=dkrOrVUBa9</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.4236/jdm.2020.103010" target="_blank" >10.4236/jdm.2020.103010</a>
Alternative languages
Result language
angličtina
Original language name
Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic
Original language description
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 < 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. 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 < 7.0% 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 -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.
Czech name
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Czech description
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Classification
Type
J<sub>ost</sub> - Miscellaneous article in a specialist periodical
CEP classification
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OECD FORD branch
30202 - Endocrinology and metabolism (including diabetes, hormones)
Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2020
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Diabetes Mellitus
ISSN
2160-5831
e-ISSN
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Volume of the periodical
10
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
15
Pages from-to
109-123
UT code for WoS article
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EID of the result in the Scopus database
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