The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli‐D randomized controlled trial

Author:

Liu Ming1ORCID,Gu Weijun2,Chen Li3ORCID,Li Yanbing4ORCID,Kuang Hongyu5,Du Jianling6,Alvarez Agustina7,Lauand Felipe8,Souhami Elisabeth8,Zhang Jiewen9,Xu Weiya10,Du Qin10,Mu Yiming2ORCID,

Affiliation:

1. Department of Endocrinology and Metabolism Tianjin Medical University General Hospital Tianjin China

2. Department of Endocrinology The First Medical Centre, Chinese People's Liberation Army General Hospital Beijing China

3. Department of Endocrinology Qilu Hospital of Shandong University Jinan China

4. Department of Endocrinology The First Affiliated Hospital, Sun Yat‐sen University Guangzhou China

5. Department of Endocrinology The First Affiliated Hospital of Harbin Medical University Harbin China

6. Department of Endocrinology The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China

7. Sanofi Madrid Spain

8. Sanofi Paris France

9. Sanofi Beijing China

10. Sanofi Shanghai China

Abstract

AbstractAimTo compare the efficacy and safety of a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin, insulin degludec plus insulin aspart (IDegAsp), in Chinese people with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drug(s) (OADs).MethodsIn Soli‐D, a 24‐week, multicentre, open‐label, study, insulin‐naïve adults were randomized 1:1 to once‐daily injections of iGlarLixi (n = 291) or IDegAsp (n = 291), with continued metformin ± sodium‐glucose co‐transporter‐2 inhibitors. The primary endpoint was non‐inferiority in HbA1c change from baseline to week 24. Key secondary endpoints included superiority in HbA1c change and body weight (BW) change at week 24. Hypoglycaemia rates were also assessed.ResultsAt week 24, iGlarLixi showed non‐inferiority and superiority over IDegAsp in HbA1c reduction (least squares [LS] mean difference: −0.20 [95% confidence interval {CI}: –0.33, −0.07]; P < .001 for non‐inferiority; [97.5% CI: –0.35, −0.05]; P = .003 for superiority). iGlarLixi decreased BW and IDegAsp increased BW from baseline to week 24, with a statistically significant LS mean difference of −1.49 kg in favour of iGlarLixi (97.5% CI: –2.32, −0.66; P < .001). Event rates (per person‐year) for American Diabetes Association (ADA) Level 1, 2 or 3 hypoglycaemia were lower for iGlarLixi (1.90) versus IDegAsp (2.72) (relative risk: 0.71; 95% CI: 0.52, 0.98). No ADA Level 3 hypoglycaemia or unexpected safety findings were reported.ConclusionsIn Chinese people with T2D suboptimally controlled with OADs, once‐daily iGlarLixi provided better glycaemic control with BW benefit and lower hypoglycaemia event rates versus IDegAsp.

Funder

Sanofi

Publisher

Wiley

Reference43 articles.

1. 9. Pharmacologic approaches to glycemic treatment: standards of care in diabetes‐2024;American Diabetes Association Professional Practice Committee;Diabetes Care,2023

2. Standards of medical care for type 2 diabetes in China 2019

3. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

4. Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition);Chinese Diabetes Society;Chin J Diabetes Mellitus,2021

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