Vildagliptin in New Onset Diabetes After Transplantation (VINODAT)
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ClinicalTrials.gov Identifier: NCT00980356 |
Recruitment Status
:
Completed
First Posted
: September 21, 2009
Last Update Posted
: April 5, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Drug: Vildagliptin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Vildagliptin in New Onset Diabetes After Transplantation - A Double-blind, Randomized, Placebo-controlled Trial |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Vildagliptin, 50 mg, peroral |
Drug: Vildagliptin
Patients receive once daily 50 mg Vildagliptin
|
Placebo Comparator: Placebo pill |
- To assess whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start compared to placebo. [ Time Frame: 3 months ]
- To assess differences in the change in HbA1c and fasting plasma glucose after 3 months after treatment start and to assess the safety and efficacy of Vildagliptin in renal transplanted patients. [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose): glucose ≥ 200mg/dl
- renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of triple therapy with tacrolimus or cyclosporine A, mycophenolate mofetil or azathioprine, and prednisone.
- stable graft function for more than 6 months post transplant.
- informed consent of the patient
Exclusion Criteria:
- patients with prior history of type 1 or type 2 diabetes
- body mass index (BMI) > 40
- pregnancy
- severe renal impairment (GFR < 30 mL/min./1.73 m2)
- severe liver impairment
- severe blood glucose elevation with the need for therapy with insulin or HbA1c >8.5%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980356
Austria | |
Medical University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Marcus D Säemann, MD | Medical University of Vienna |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marcus Saemann, Prof. Dr. Marcus Säemann, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00980356 History of Changes |
Other Study ID Numbers: |
EudraCT: 2009-14405-14 EK645/2009 |
First Posted: | September 21, 2009 Key Record Dates |
Last Update Posted: | April 5, 2013 |
Last Verified: | August 2012 |
Keywords provided by Marcus Saemann, Medical University of Vienna:
Diabetes Kidney transplantation New onset diabetes mellitus after transplantation |
Additional relevant MeSH terms:
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |