Diabetes Obes Metab. 2025;27(5):2730-2739.

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

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제1저자 Martin Haluzík · 교신저자 Martin Haluzík, 임수

PMID 40098261 PMC11965013 DOI 10.1111/dom.16276 IF 6.1 내분비대사내과

소속 (6)

Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Department of Internal Diseases and Diabetology, Medical University of Lodz, Lodz, Poland.
Sanofi, Madrid, Spain.
Sanofi, Paris, France.
Adana Dr. Turgut Noyan Training and Research Hospital, Endocrinology, Baskent University, Adana, Turkey.
Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Abstract

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: ≥18 years; premixed insulin therapy for ≥3 months and < 10 years; ± 1-2 oral antidiabetic drugs (OADs); HbA1c ≥7.5% to ≤10.0%. The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included: participants achieving HbA1c <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 <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.

Keywords

clinical trialiGlarLixiinsulin glarginelixisenatidephase IV studytype 2 diabetes

Figures

**FIGURE 1** Change from baseline to Week 24 in the overall population for (A) HbA1c, (B) FPG, PPG and fasting SMPG and (C) Mean 7‐point SMPG profile over a single 24‐h period, (D) total daily insulin dose, (E) total daily insulin dose by body weight and (F) body weight. CI, confidence interval; HbA1c, glycated haemoglobin; FPG, fasting plasma glucose; n, number; LS, least squares; PPG, post‐prandial glucose; SD, standard deviation; SE, standard error; SMPG, self‐measured plasma glucose.

**FIGURE 2** Participants in the overall population who switched to iGlarLixi without deterioration of glycaemic control, achieving HbA1c <7% and achieving HbA1c <7% with composite endpoints at Week 24. Clinically relevant hypoglycaemia is defined as any hypoglycaemia (ADA Level 2) or severe hypoglycaemia (ADA Level 3) event. CI, confidence interval; HbA1c, glycated haemoglobin; iGlarLixi, insulin glargine 100 U/mL + lixisenatide.

**FIGURE 3** Derived time‐below‐range, derived time‐in‐range and derived time‐above‐range at baseline and Week 24 for the overall population. dTAR, derived time above range; dTBR, derived time below range; dTIR, derived time in range; SMPG, self‐monitored plasma glucose; SD, standard deviation.

그림 출처: PubMed Central 공개 논문 (PMC11965013)

Conflict of interest statement

MH received lecture fees from Sanofi, Novo Nordisk, Eli Lilly, Novartis, Merck, Berlin Chemie, Astra Zeneca and Boehringer Ingelheim and research support from Sanofi. SL received honoraria for speaking from Astra Zeneca, Novo Nordisk, Boehringer Ingelheim and LG chem. KC received honoraria for speaking from Novo Nordisk, Eli Lilly, Merck, Boehringer Ingelheim, AstraZeneca and Sanofi. AA, FL and VCdG are employees of Sanofi and may hold shares and/or stock options in the company. OSB received honoraria for speaking from Novo Nordisk, Eli Lilly and Sanofi.

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