Empagliflozin Versus Linagliptin in Renal Ransplant Recipients With Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This EmLina Renal trial is an investigator initiated, single-center, prospective, open-label, randomized clinical study to examine the safety and effect of empagliflozin 25 mg once a day vs. linagliptin 5 mg once a day for 12 months on glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus. Glycemic variables will include fasting glucose and glycated hemoglobin (HbA1c). Renal outcomes will include change in eGFR, spot urine albumin-creatinine ratio (UACR) and spot urine protein-creatinine ratio (UPCR). Body composition variables will include total fat mass, fat percentage, total lean mass, and bone mineral content as measured by dual-energy X-ray absorptiometry (DEXA). Body composition will also be measured by BIA. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine and nephrology out-patient clinic. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medanta, The Medicity, India
• Treatments: Empagliflozin; Linagliptin

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.