Status:
UNKNOWN
Empagliflozin Versus Linagliptin in Renal Ransplant Recipients With Diabetes Mellitus
Lead Sponsor:
Medanta, The Medicity, India
Conditions:
Diabetes Mellitus
Kidney Transplant; Complications
Eligibility:
All Genders
30+ years
Phase:
NA
Brief 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. linaglipt...
Detailed Description
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. linaglipt...
Eligibility Criteria
Inclusion
- 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.
- Patients must have stable renal function (less than 20% deviation in serum creatinine in last one month: eGFR \>30 ml/min/1.73 m2)
- Patients must be on a stable immunotherapy for last one month.
- Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations.
- Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- 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
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- 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.
- BMI \<=18 kg/m2
- 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.
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
- Contraindications to the use of empagliflozin or linagliptin (per Prescribing Information).
- History of recurrent urinary tract infections.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06098625
Start Date
November 10 2023
End Date
December 1 2025
Last Update
October 24 2023
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