1. 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
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Liu M, Gu W, Chen L, Li Y, Kuang H, Du J, Alvarez A, Lauand F, Souhami E, Zhang J, Xu W, Du Q, and Mu Y
- Subjects
- Humans, Male, Middle Aged, Female, Aged, China epidemiology, Hypoglycemia chemically induced, Hypoglycemia epidemiology, Peptides administration & dosage, Peptides adverse effects, Peptides therapeutic use, Treatment Outcome, Adult, Blood Glucose drug effects, Asian People, Administration, Oral, Metformin therapeutic use, Metformin administration & dosage, Metformin adverse effects, Drug Therapy, Combination, Glucagon-Like Peptide-2 Receptor, East Asian People, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 blood, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents adverse effects, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Glycated Hemoglobin drug effects, Drug Combinations, Insulin Glargine administration & dosage, Insulin Glargine therapeutic use, Insulin Glargine adverse effects, Insulin, Long-Acting administration & dosage, Insulin, Long-Acting therapeutic use, Insulin, Long-Acting adverse effects
- Abstract
Aim: To 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)., Methods: In 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., Results: At 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., Conclusions: In 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., (© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2024
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