Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation (ISINODAT)

Medical University of Vienna

Status and phase: Terminated; Phase 2

Conditions: New Onset Diabetes Mellitus After Renal Transplantation

Treatments: Drug: Cyclosporine A; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01268995

EudraCT: 2009-012712-40

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Cyclosporine A

Experimental group

Description:

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.

Treatment:

Drug: Cyclosporine A

Tacrolimus

Active Comparator group

Description:

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.

Treatment:

Drug: Tacrolimus