Empagliflozin Versus Linagliptin in Renal Ransplant Recipients With Diabetes Mellitus
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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