Comparing empagliflozin and linagliptin for diabetes management in kidney transplant recipients

Effect of Empagliflozin Versus Linagliptin on Glycemic Outcomes, Renal Outcomes and Body Composition in Renal Transplant Recipients With Diabetes Mellitus: Randomized Controlled Trial (EmLina Renal Trial)

This study is testing whether the diabetes medications empagliflozin and linagliptin can help kidney transplant recipients manage their blood sugar and improve their overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Medanta, The Medicity, India (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Gurgaon, Haryana)
• Trial ID: NCT06095492 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of empagliflozin and linagliptin on glycemic control, renal function, and body composition in renal transplant recipients with diabetes mellitus. It is a single-center, open-label, randomized study conducted over 12 months, focusing on patients who have undergone renal transplantation at least three months prior. Key outcomes include changes in fasting glucose, HbA1c, eGFR, and body composition metrics. The study aims to provide insights into the safety and efficacy of these medications in a unique patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 and above with diabetes mellitus who are at least three months post-renal transplantation.

Not a fit: Patients with type 1 diabetes or those who have had a history of diabetic ketoacidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diabetes management and renal health in kidney transplant recipients.

How similar studies have performed: While SGLT2 inhibitors have shown promise in other populations, this specific approach in renal transplant recipients is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Gurgaon, Haryana

• Division Of Endocrinology & Diabetes, Medanta The Medicity — Gurgaon, Haryana, India (Recruiting)

Study contacts

• Study coordinator: Mr Surender, Phd

Conditions Kidney Transplant; Complications; Diabetes Mellitus