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

This study has been terminated.
(It was impossible to recruit the scheduled number of patients)
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01268995
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 3, 2011
January 3, 2011
September 2009
Not Provided
90 days OGTT [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • Beta cell function [ Time Frame: 90 and 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
    The rate of episodes of acute allograft rejection will be compared between the two treatment arms.
  • Hypoglycemia [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
    The rate of clinically relevant hypoglycemic episodes will be desribed.
Same as current
Not Provided
Not Provided
 
Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation
A Randomized, Prospective Trial to Evaluate the Effect of Conversion From Tacrolimus to Cyclosporine A After Early Initiation of Insulin Therapy in Patients With New-onset Diabetes Mellitus After Kidney Transplantation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
New Onset Diabetes Mellitus After Renal Transplantation
  • Drug: Cyclosporine A
    Patients randomized into arm A will be switched from Tacrolimus to Cyclosporine A. Conversion will be done by a "stop and go" protocol. Patients will take their last dose Tacrolimus in the morning of the day of conversion and will start taking Cyclosporine A in the evening of the same day at a dose of 3mg/kg/d. The first measurement of Cyclosporine A trough levels will be performed 3 days after conversion and the dose will then be adjusted if necessary. Furthermore, treatment with NPH insulin once daily in the morning will be initiated.
  • Drug: Tacrolimus
    Patients in arm B will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, treatment with NPH insulin once daily in the morning will be initiated.
  • Experimental: 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.
    Intervention: Drug: Cyclosporine A
  • Active Comparator: 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.
    Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
December 2010
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01268995
EudraCT: 2009-012712-40
Yes
Dr. Marcus Säemann, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP