Intensive insulin therapy de-intensification with IGlarLixi in type 2 diabetes patients: results of the IDEAL randomised clinical trial

Czech version

Authors: Peter Novodvorský ¹; Lenka Thieme ¹; Ivana Laňková ¹; Štěpánka Fraňková ¹; Alica Veselá ²; Emil Záhumenský ³; Tomáš Edelsberger ⁴; Marie Löblová ⁵; Ondřej Žižka ¹; Miroslav Vytasil ⁶; Felipe Lauand ⁷; Mireille Bonnemaire ⁷; Filip Hrubý ⁸; Miloš Mráz ^1,9; Martin Haluzík ^1,9
Authors‘ workplace: Centrum diabetologie IKEM, Praha, Česká republika ¹; EDUMED s. r. o., Náchod, Česká republika ²; Diabetologická a angiologická ambulance, Valašské Klobouky, Česká republika ³; DiaKrnov s. r. o., Krnov, Česká republika ⁴; Diaclinic s. r. o., České Budějovice, Česká republika ⁵; Sanofi s. r. o., Praha, Česká republika ⁶; General Medicines, Sanofi, Paris, France ⁷; Oddělení datových věd IKEM, Praha, Česká republika ⁸; Ústav lékařské biochemie a laboratorní diagnostiky 1. LF UK a VFN v Praze, Česká republika ⁹
Published in: Diab Obez 2026; 26(1): 9-18
Category: Clinical studies

Overview

Aims: To evaluate the efficacy and safety of transitioning from Multiple Daily Injections (MDI) insulin regimen to once-daily, fixed-ratio combination of basal insulin analogue glargine 100 U/mL and a glucagon-like peptide 1 receptor agonist lixisenatide (IGlarLixi) in persons with type 2 diabetes (PsT2D). Materials and methods: Insulin therapy DE-intensificAtion with IGlarLixi (IDEAL) was a 5-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period. Eligible PsT2D (age 18–80 years, HbA_1c ≤ 9 %/75 mmol/mol, total daily dose of insulin ≤ 0.8 IU/kg, and fasting C-peptide above the lower limit of normal) were randomised in a 1 : 1 fashion to IGlarLixi initiation or continuation with MDI regimen. The primary endpoint was the mean change in HbA_1c from baseline to 24 weeks after randomisation between the two treatment groups. Results: Ninety individuals (n = 45 in both treatment groups), 71/91 (79.0%) male with mean age 66.2 (8.7) years, HbA_1c 7.9 (1.0) %/62.8 (10.9) mmol/mol, diabetes duration 17.5 (8.7) years and BMI 33.6 (5.5) kg/m² were analysed. The mean (95% CI) difference in the change in HbA_1c between the IGlarLixi and the MDI group was -0.12 % (-0.48, 0.23) /-1.39 (-5.21, 2.43 mmol/mol indicating comparable glycaemic control in both treatment groups. Significant between-group differences in favour of IGlarLixi were observed in body weight: -4.19 (-5.95, -2.43) kg, BMI: -1.49 (-2.11, -0.86) kg/m², total daily dose of insulin: -28.57 (-34.89, -22.24) IU, time spent in level 2 hyperglycaemia: -4.9 (-9.4, -0.34) %, and glycaemia risk index: -13.6 (-25.1, -2.1). The DTQSs/DTSQc treatment satisfaction scores were higher in the IGlarLixi group in comparison to the MDI group. Conclusions: Insulin therapy simplification from MDI regimen to once-daily IGlarLixi is an efficient and safe treatment option for PsDM2T with comparable glycaemic control and the benefits of weight reduction, reduction of total daily dose of insulin, number of insulin injections per day, then spent in level 2. hyperglycaemia as well as other benefits.

Keywords:

IGlarLixi – type 2 diabetes (T2D) – insulin therapy simplification (de-intensification) – Multiple Daily Injections insulin regimen (MDI) – Randomised controlled trial (RCT)

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