Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus

NCT06095492 | Recruiting DMC

• 1 other identifier: MMENDO01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Complications; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Estimated glomerular filtration rate (eGFR)

  Basline to 12 Months

• Spot urine albumin- creatinine ratio

  Basline to 12 Months

• Spot urine protein-creatinine ratio

  Basline to 12 Months

Secondary Outcomes (6)

• Changes in total fat content

  Basline to 12 Months

• Changes in fat percentage

  Basline to 12 Months

• Changes in lean mass

  Basline to 12 Months

• Changes in bone mineral content

  Basline to 12 Months

• Changes in fasting glucose

  Basline to 12 Months

Study Arms (2)

Empa group

EXPERIMENTAL

Drug: Empagliflozin 25 MG

Lina group

ACTIVE COMPARATOR

Drug: Linagliptin

Interventions

Empagliflozin 25 MG DRUG

Patient will get Empagliflozin 25

Empa group

Linagliptin DRUG

linagliptin 5 mg once a day

Lina group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medanta, The Medicity, India: lead

Study Sites (1)

Division Of Endocrinology & Diabetes, Medanta The Medicity

Gurgaon, Haryana, 122001, India

RECRUITING

Related Publications (7)

• Halden TAS, Kvitne KE, Midtvedt K, Rajakumar L, Robertsen I, Brox J, Bollerslev J, Hartmann A, Asberg A, Jenssen T. Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus. Diabetes Care. 2019 Jun;42(6):1067-1074. doi: 10.2337/dc19-0093. Epub 2019 Mar 12.

  PMID: 30862658 RESULT

• Baron PW, Infante S, Peters R, Tilahun J, Weissman J, Delgado L, Kore AH, Beeson WL, de Vera ME. Post-Transplant Diabetes Mellitus After Kidney Transplant in Hispanics and Caucasians Treated with Tacrolimus-Based Immunosuppression. Ann Transplant. 2017 May 23;22:309-314. doi: 10.12659/aot.903079.

  PMID: 28533501 RESULT

• Cosio FG, Kudva Y, van der Velde M, Larson TS, Textor SC, Griffin MD, Stegall MD. New onset hyperglycemia and diabetes are associated with increased cardiovascular risk after kidney transplantation. Kidney Int. 2005 Jun;67(6):2415-21. doi: 10.1111/j.1523-1755.2005.00349.x.

  PMID: 15882287 RESULT

• Sharif A, Hecking M, de Vries AP, Porrini E, Hornum M, Rasoul-Rockenschaub S, Berlakovich G, Krebs M, Kautzky-Willer A, Schernthaner G, Marchetti P, Pacini G, Ojo A, Takahara S, Larsen JL, Budde K, Eller K, Pascual J, Jardine A, Bakker SJ, Valderhaug TG, Jenssen TG, Cohney S, Saemann MD. Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. Am J Transplant. 2014 Sep;14(9):1992-2000. doi: 10.1111/ajt.12850. Epub 2014 Aug 6.

  PMID: 25307034 RESULT

• Guardado-Mendoza R, Cazares-Sanchez D, Evia-Viscarra ML, Jimenez-Ceja LM, Duran-Perez EG, Aguilar-Garcia A. Linagliptin plus insulin for hyperglycemia immediately after renal transplantation: A comparative study. Diabetes Res Clin Pract. 2019 Oct;156:107864. doi: 10.1016/j.diabres.2019.107864. Epub 2019 Sep 17.

  PMID: 31539565 RESULT

• Haidinger M, Werzowa J, Hecking M, Antlanger M, Stemer G, Pleiner J, Kopecky C, Kovarik JJ, Doller D, Pacini G, Saemann MD. Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation--a randomized, double-blind, placebo-controlled trial. Am J Transplant. 2014 Jan;14(1):115-23. doi: 10.1111/ajt.12518. Epub 2013 Nov 26.

  PMID: 24279801 RESULT

• Soliman AR, Fathy A, Khashab S, Shaheen N, Soliman MA. Sitagliptin might be a favorable antiobesity drug for new onset diabetes after a renal transplant. Exp Clin Transplant. 2013 Dec;11(6):494-8. doi: 10.6002/ect.2013.0018.

  PMID: 24344941 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Central Study Contacts

Mr Surender, Phd

CONTACT

0124141414; yadavsurender89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: A research assistant will randomize the patients into either Empa group or Lina group in a 1:1 ratio using computer-generated numbers.

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 23, 2023
• Study Start: October 30, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)