| Trial ID: | L3947 |
| Source ID: | NCT01268995
|
| Associated Drug: |
Cyclosporine A
|
| Title: |
Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation
|
| Acronym: |
ISINODAT
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
New Onset Diabetes Mellitus After Renal Transplantation
|
| Interventions: |
DRUG: Cyclosporine A|DRUG: Tacrolimus
|
| Outcome Measures: |
Primary: 90 days OGTT, 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., 90 days | Secondary: Beta cell function, 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., 90 and 180 days|Graft rejection, The rate of episodes of acute allograft rejection will be compared between the two treatment arms., whole study period|Hypoglycemia, The rate of clinically relevant hypoglycemic episodes will be desribed., whole study period
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Vienna
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-09
|
| Completion Date: |
2010-12
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-04
|
| Locations: |
Medical University of Vienna/General Hospital, Vienna, A-1090, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT01268995
|
