Efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes: The Soli-SWITCH study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F25%3A00085496" target="_blank" >RIV/00023001:_____/25:00085496 - isvavai.cz</a>

Výsledek na webu

<a href="https://dom-pubs.pericles-prod.literatumonline.com/doi/epdf/10.1111/dom.16276" target="_blank" >https://dom-pubs.pericles-prod.literatumonline.com/doi/epdf/10.1111/dom.16276</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/dom.16276" target="_blank" >10.1111/dom.16276</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes: The Soli-SWITCH study

Popis výsledku v původním jazyce

Aims To assess the efficacy and safety of switching from premixed insulin to a once-daily, fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D). Methods In this phase 4, 24-week, single-arm study, participants switched from once-daily or twice-daily premixed insulin to iGlarLixi (EudraCT number 2021-003711-25). Key inclusion criteria: &gt;= 18 years; premixed insulin therapy for &gt;= 3 months and &lt; 10 years; +/- 1-2 oral antidiabetic drugs (OADs); HbA1c &gt;= 7.5% to &lt;= 10.0%. The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included: participants achieving HbA1c &lt;7% and change in body weight at Week 24, and safety. Results Overall, 162 participants switched to iGlarLixi (89.5% from twice-daily premixed insulin); mean duration of diabetes was 15.7 (standard deviation [SD]: 8.3) years. Mean baseline HbA1c (8.5%) reduced by least squares (LS) mean of 1.2% (95% confidence interval [CI]: -1.4, -1.1) at Week 24, and 37.6% of participants had achieved an HbA1c target of &lt;7% (95% CI: 30.0, 45.7). LS mean body weight change from baseline to Week 24 was -1.0 kg (95% CI: -1.6, -0.5). Fasting and post-prandial plasma glucose decreased from baseline to Week 24 by 45.6 mg/dL (SD +/- 52.4) and 67.6 mg/dL (SD +/- 65.1), respectively. Confirmed symptomatic hypoglycaemia occurred in 38.3% of participants (ADA level 1: 35.8%; level 2: 15.4%; level 3: 0.0%). Conclusions iGlarLixi initiation was associated with improved glycaemic control, without body weight gain or increased hypoglycaemia over 24 weeks.

Název v anglickém jazyce

Efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes: The Soli-SWITCH study

Popis výsledku anglicky

Aims To assess the efficacy and safety of switching from premixed insulin to a once-daily, fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D). Methods In this phase 4, 24-week, single-arm study, participants switched from once-daily or twice-daily premixed insulin to iGlarLixi (EudraCT number 2021-003711-25). Key inclusion criteria: &gt;= 18 years; premixed insulin therapy for &gt;= 3 months and &lt; 10 years; +/- 1-2 oral antidiabetic drugs (OADs); HbA1c &gt;= 7.5% to &lt;= 10.0%. The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included: participants achieving HbA1c &lt;7% and change in body weight at Week 24, and safety. Results Overall, 162 participants switched to iGlarLixi (89.5% from twice-daily premixed insulin); mean duration of diabetes was 15.7 (standard deviation [SD]: 8.3) years. Mean baseline HbA1c (8.5%) reduced by least squares (LS) mean of 1.2% (95% confidence interval [CI]: -1.4, -1.1) at Week 24, and 37.6% of participants had achieved an HbA1c target of &lt;7% (95% CI: 30.0, 45.7). LS mean body weight change from baseline to Week 24 was -1.0 kg (95% CI: -1.6, -0.5). Fasting and post-prandial plasma glucose decreased from baseline to Week 24 by 45.6 mg/dL (SD +/- 52.4) and 67.6 mg/dL (SD +/- 65.1), respectively. Confirmed symptomatic hypoglycaemia occurred in 38.3% of participants (ADA level 1: 35.8%; level 2: 15.4%; level 3: 0.0%). Conclusions iGlarLixi initiation was associated with improved glycaemic control, without body weight gain or increased hypoglycaemia over 24 weeks.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Diabetes, obesity and metabolism

ISSN

1462-8902

e-ISSN

1463-1326

Svazek periodika

27

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

2730-2739

Kód UT WoS článku

001447081700001

EID výsledku v databázi Scopus

2-s2.0-105000273229