Comparing empagliflozin and linagliptin for diabetes management in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Mr Surender, Phd
• Email: yadavsurender89@gmail.com
• Phone: 0124141414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.