Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00064165:_____/20:10419905

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic

Popis výsledku v původním jazyce

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 &lt; 7.0% DCCT (&lt; 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 &lt; 0.0001). HbA1c target &lt; 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 &lt; 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&apos; satisfaction with treatment increased.

Název v anglickém jazyce

Insulin Glargine 300 Units/mL Effectiveness in Patients with T2DM Uncontrolled by Basal Insulin in Real-Life Settings in the Czech Republic

Popis výsledku anglicky

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 &lt; 7.0% DCCT (&lt; 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 &lt; 0.0001). HbA1c target &lt; 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 &lt; 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&apos; satisfaction with treatment increased.

Druh

J_ost - Ostatní články v recenzovaných periodicích

CEP obor

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OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Diabetes Mellitus

ISSN

2160-5831

e-ISSN

—

Svazek periodika

10

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

15

Strana od-do

109-123

Kód UT WoS článku

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EID výsledku v databázi Scopus

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