Comparison of efficacy and safety of insulin degludec/liraglutide and insulin glargine U-100/lixisenatide in individuals with type 2 diabetes mellitus using professional continuous glucose monitoring.

AIM/INTRODUCTION: Insulin glargine U100/lixisenatide and insulin degludec/liraglutide are fixed-ratio combinations containing basal insulin and a glucagon-like peptide-1 receptor agonist capable of reducing both fasting and postprandial blood glucose levels with a single formulation. This study aimed to compare the time in range (TIR) and the time below range (TBR) level 1 using professional continuous glucose monitoring and to establish criteria for the differential use of the fixed-ratio combinations. MATERIALS AND METHODS: Thirty-six outpatients with type 2 diabetes mellitus (24 men and 12 women; average age, 62.1 years) were randomly assigned to the groups. At 0 and 18 weeks, a device was worn to compare the TIR and TBR level 1. The correlation between the C-peptide index at baseline and TIR at 18 weeks was assessed. RESULTS: The TIR and TBR level 1 showed no significant differences between the two groups. Both groups showed significant positive correlations between the C-peptide index and the TIR (P = 0.002, r = 0.679; P = 0.002, r = 0.681, respectively). The changes in glycemic variability, therapeutic indices, and body mass index were not significantly different among the groups (P > 0.05). The receiver operating curve analysis revealed that the cut-off values of the C-peptide index to achieve TIR of >70% at 18 weeks were 1.258 (sensitivity, 77.8%; specificity, 100%) and 1.099 (sensitivity, 57.1%; specificity, 90.9%) in the insulin glargine U100/lixisenatide and insulin degludec/liraglutide groups, respectively. CONCLUSIONS: A TIR of >70% was achieved for both fixed-ratio combinations without significant differences.

Efficacy and safety of finerenone in individuals with type 2 diabetes mellitus complicated by diabetic kidney disease: A retrospective observational study.

Aim/introduction: Early therapeutic interventions are necessary to reduce cardiovascular and renal composite endpoints in individuals with type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD). Clinical trials have shown that finerenone suppresses cardiovascular and renal composite endpoints by reducing the urinary albumin-to-creatinine ratio (UACR) and suppressing the decline in the Estimated Glomerular Filtration Rate (eGFR). However, the efficacy and safety of finerenone in real-world clinical practice remain unclear. This study aimed to evaluate the reduction in the UACR as an efficacy endpoint as well as changes in eGFR and serum potassium levels as safety endpoints before and after finerenone administration. Materials and methods: This retrospective observational study collected data from outpatients with T2DM and DKD upon initiation of finerenone treatment and 3 months after treatment. The primary efficacy endpoint was the change in the UACR from the start of finerenone treatment to after 3 months, while the primary safety endpoints were the changes in serum potassium levels and eGFR over the same period. Results: The mean UACR significantly decreased from 668.6 mg/gCr at the start of finerenone treatment to 367.8 mg/gCr after 3 months (p < 0.001). Contrastingly, serum potassium levels, eGFRs, systolic and diastolic blood pressures, body mass indices, and HbA1c levels showed no significant changes between treatment initiation and 3 months post-treatment (all p > 0.05). Conclusions: In individuals with T2DM and DKD, finerenone treatment significantly reduced the UACR, with no post-treatment changes in potassium levels or eGFRs. Trial registration: This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (UMIN000054821).