Overview
Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus
Status:
Recruiting
Recruiting
Trial end date:
2025-12-01
2025-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce. DPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation. Since patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established. In this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Medanta, The Medicity, IndiaTreatments:
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.