Comparison of Outcomes of Linagliptin Plus Insulin and Insulin Only Among Type II Diabetes Mellitus Patients with Chronic Kidney Disease

Abstract

Objective: To compare the outcomes of linagliptin plus insulin versus insulin alone among patients with type II diabetes mellitus with chronic kidney disease.

Study Design: Randomized clinical trial study
Place and Duration of Study: This study was conducted at the Department of Medicine, Fauji Foundation Hospital, Rawalpindi, Pakistan, from October 2025 to December 2025.

Methods: A total of 284 patients with type II diabetes mellitus and chronic kidney disease were included in the study and randomly allocated into two equal groups. Group A received linagliptin 5 mg once daily in addition to insulin therapy, while Group B received insulin therapy alone. Patients aged 18–75 years with eGFR between 15–45 ml/min and HbA1c >6.5% were enrolled. Baseline demographic and clinical parameters including age, gender, BMI, duration of diabetes, CKD grade, HbA1c, and urine protein-creatinine ratio (UPCR) were recorded. Patients were followed for three months and post-treatment HbA1c and UPCR were measured. Data were analyzed using SPSS version 25. Independent sample t-test was applied to compare outcomes between the groups, with p ≤0.05 considered statistically significant.

Results: The mean age of the participants was 54.3 ± 10.7 years, with 158 (55.6%) males and 126 (44.4%) females. The mean BMI was 27.6 ± 4.2 kg/m². After three months of treatment, the mean HbA1c was significantly lower in the linagliptin plus insulin group (7.2 ± 0.6%) compared with the insulin-only group (7.6 ± 0.8%) (p = 0.001). Similarly, renal outcomes measured through urine protein-creatinine ratio improved in the combination therapy group (0.82 ± 0.14 mg/g) compared with the insulin-only group (0.91 ± 0.16 mg/g) (p = 0.003). Stratified analysis showed consistent improvement across different age groups and genders.

Conclusion: Linagliptin combined with insulin demonstrated significantly better glycaemic control and improvement in proteinuria compared with insulin monotherapy in patients with type II diabetes mellitus and chronic kidney disease.