Efficacy and Safety of Empagliflozin versus Linagliptin as Add on Therapy to Insulin in Patients of Chronic Kidney Disease and Type 2 Diabetes Mellitus: A Randomised Controlled Trial

Introduction:Patients with an eGFR of less than 60 ml/min have a limited selection of medication alternatives for glycaemic management.Most oral anti-diabetic medications are either not recommended or require dose decrease to prevent kidney damage, which would reduce their effectiveness and result in poor glycaemic control.Finding a medication that is quick acting, safe, and successful in attaining correct glycaemic control and so postponing the beginning and progression of CKD is crucial.Aims/ objective: To compare the efficacy and safety of empagliflozin and linagliptin as add-on therapies to insulin in patients with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease. Materials and Method:Following screening and application of the inclusion and exclusion criteria, 120 patients were randomly assigned, with 60 patients in each group using web-generated random numbers.Patients in the empagliflozin group received 10 mg of empagliflozin once daily in addition to their regular insulin medication, while those in the linagliptin group received 5 mg of linagliptin once daily.HbA1c, fasting blood sugar, eGFR, urine protein-creatinine ratio (UPCR) was recorded at baseline, 3 months, 6 months and 12 months of follow-up and compared between two groups.Results: At 6 month and 12 months of follow up, HbA1c was lower in patients receiving empagliflozin than patients receiving linagliptin with statistically significant difference (p<0.05).Both the groups showed significant decline in mean HbA1c from baseline and end of the study (p<0.05).There was no statistically significant decline in eGFR in patients receiving linagliptin or empagliflozin (p>0.05).The decline in UPCR was better in patients receiving empagliflozin than patients receiving linagliptin with statistically significant difference (p<0.05).Gastrointestinal adverse effects were limiting adverse events in linagliptin pharmacotherapy whereas hypoglycaemia and urinary tract infection were frequent adverse effect associated with empagliflozin. Conclusion:Empagliflozin has been demonstrated to be more efficacious than linagliptin when added to background insulin treatment.By reducing the amount of insulin needed to achieve the ideal blood glucose level, oral hypoglycaemic medications might reduce the risk of hypoglycaemia and weight gain associated with insulin therapy.