782-P: Insulin Therapy Deintensification with iGlarLixi—The IDEAL Randomized Controlled Trial

Introduction: Multiple daily injection (MDI) insulin therapy in people with type 2 diabetes (PwT2D) often leads to weight gain, increased risk of hypoglycemia and lower QoL. The Insulin therapy DE-intensificAtion with iglarLixi (IDEAL) trial examined the efficacy and safety of MDI de-intensification into once-daily administered FRC of insulin glargine U100 and GLP-1 RA lixisenatide (iGlarLixi) in PwT2D.

Methods: IDEAL was a 5-centre, open-label, parallel-group, phase 4 RCT with a 24-week treatment period. Eligible individuals (age 18-80 years, total daily dose of insulin [TDD] ≤ 0.8 IU/kg and fasting c-peptide above the lower limit of normal) were randomized in a 1:1 fashion into once-daily administered iGlarLixi or continuation with MDI, both titrated to fasting plasma glucose (FPG) ≤ 6 mmol/L (108 mg/dL). Primary outcome was HbA1c change at 24 weeks. Secondary outcomes were change in body weight (BW), TDD, FPG, postprandial glycemia (PPG), hypoglycemia, CGM-related metrics and QoL.

Results: Altogether 91 individuals (20/91, 22% women) with mean (SD) age 66 (9) years, diabetes duration 17 (9) years and BMI 33.5 (5.5) kg/m² were analyzed. Mean change in HbA1c in the iGlarLixi group was non-inferior to the MDI group (-0.47 [0.91] % vs (-0.37 [0.77] %, p = 0.01 for non-inferiority, p = 0.25 for superiority). Mean reduction in BW in the iGlarLixi group was higher in comparison to the MDI group (-4.8 [4.3] kg vs -0.5 [3.7] kg, p < 0.001). TDD reduced in the iGlarLixi group (p < 0.0001) and remained unchanged in the MDI group (p = 0.233). The proportion of study visits at which hypoglycemia was reported was lower in the iGlarLixi vs MDI group (5.5% vs 9.6%, p = 0.029). No differences in FPG and PPG were observed.

Conclusion: Insulin therapy de-intensification from MDI into iGlarLixi is an efficient and safe treatment option for PwT2D that provides comparable glycemic control with the benefits of reduction of BW, TDD, number of insulin injections and lower proportion of visits as which hypoglycemia was reported.