Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation

Phase 2

Terminated

• Conditions: New Onset Diabetes Mellitus After Renal Transplantation
• Interventions: Drug: Cyclosporine A; Drug: Tacrolimus

• Registration Number: NCT01268995
• Lead Sponsor: Medical University of Vienna

Brief Summary

New onset diabetes after transplantation (NODAT) is a frequent and feared complication after kidney transplantation and leads to an increase in cardiovascular complications as well as in the rate of graft loss. Very little data exist on how patients in which NODAT has been diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the function of the insulin secreting cells in the pancreas. Therefore, the investigators test the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed NODAT who have just started early treatment with insulin. The hypothesis is that patients who are treated with insulin and who are switched to Cyclosporine A have improved glucose metabolism compared to patients who are treated with insulin and who remain on Tacrolimus therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study Completion: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Last Update Submitted: 2011-01-03
• Study First Posted: 2011-01-04
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose):

glucose ≥ 200mg/dl

• Defect in insulin secretion as judged by OGTT and HOMA B
• Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction
• stable graft function for more than 3 months post transplant
• informed consent of the patient

Exclusion Criteria

• patients with prior history of type 1 or type 2 diabetes
• time since transplantation more than 20 years
• allergy against long-acting insulin or cyclosporine A
• body mass index (BMI) > 35
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporine A	Cyclosporine A	Patients in this arm will be switched from immunosuppressive therapy with Tacrolimus to Cyclosporine A. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.
Tacrolimus	Tacrolimus	Patients in this arm will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.

Primary Outcome Measures

Name	Time	Method
90 days OGTT	90 days	The primary endpoint will be the difference in the 2h glucose value obtained from an oral glucose tolerance test (OGTT) after 90 days compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Beta cell function	90 and 180 days	One secondary endpoint is the change in beta cell function after 90 days compared to baseline as determined by a frequent sampling oral glucose glucose tolerance test.
Graft rejection	whole study period	The rate of episodes of acute allograft rejection will be compared between the two treatment arms.
Hypoglycemia	whole study period	The rate of clinically relevant hypoglycemic episodes will be desribed.

Trial Locations

Locations (1)

Medical University of Vienna/General Hospital; 🇦🇹 Vienna, Austria