Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus

NCT06095492 · tracked via the Priya Life Science India tracker

Sponsor

Medanta, The Medicity, India

Phase

Not applicable

Started

2023-10-30

Last updated

2024-12-05

Condition(s) studied

Kidney Transplant; ComplicationsDiabetes Mellitus

Investigational drug(s) / intervention(s)

Empagliflozin 25 MGLinagliptin

Empagliflozin 25 MG: Patient will get Empagliflozin 25

Linagliptin: linagliptin 5 mg once a day

Study summary

In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce.

DPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation.

Since patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established.

In this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.

Eligibility

Sex

ALL

Min age

30 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. A man or woman, 30 years of age or above with the diagnosis of diabetes mellitus (pre-transplantation type 2 diabetes or post-transplantation diabetes mellitus) and after at least 3 months of renal transplantation. 2. Patients must have stable renal function (less than 20% deviation in serum creatinine in last one month: eGFR \>30 ml/min/1.73 m2) 3. Patients must be on a stable immunotherapy for last one month. 4. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations. 5. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 6. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study. Exclusion Criteria: 1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. 2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely. 3. BMI \<=18 kg/m2 4. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report. 5. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation. 6. Contraindications to the use of empagliflozin or linagliptin (per Prescribing Information). 7. History of recurrent urinary tract infections.

Primary outcome measure(s)

Estimated glomerular filtration rate (eGFR) — Basline to 12 Months
Spot urine albumin- creatinine ratio — Basline to 12 Months
Spot urine protein-creatinine ratio — Basline to 12 Months

Trial sites (1)

Facility	City	Region	Status
Division Of Endocrinology & Diabetes, Medanta The Medicity	Gurgaon	Haryana	Recruiting

On this site

📄 Tradjenta (linagliptin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095492 on ClinicalTrials.gov ↗ ← All trials in India