Vildagliptin in New Onset Diabetes After Transplantation (VINODAT)
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| ClinicalTrials.gov Identifier: NCT00980356 |
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Recruitment Status
:
Completed
First Posted
: September 21, 2009
Last Update Posted
: April 5, 2013
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Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna
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Brief Summary:
The purpose of this study is to determine whether monotherapy with Vildagliptin improve glycemic control in kidney transplanted patients with newly diagnosed New Onset Diabetes after Transplantation (NODAT).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus | Drug: Vildagliptin | Phase 2 |
Development of new onset diabetes mellitus after transplantation (NODAT) also called post-transplant diabetes mellitus (PTDM) increases the risk of cardiovascular disease and poor short term clinical outcomes. There is currently no doubt about the fact that NODAT is a condition that needs medical attention and treatment. Although most centers follow treatment regimens for DM type II prospective data about their effectiveness in NODAT are lacking. Little information exists in kidney transplantation regarding conventional glucose-lowering therapies, either oral hypoglycemic agents or traditional insulin regimens. The Aim of this study was to evaluate whether a monotherapy with Vildagliptin improve glycemic control and to assess the safety in kidney transplanted patients with newly diagnosed NODAT.
| 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
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| Placebo Comparator: Placebo pill |
Primary Outcome Measures
:
- 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 ]
Secondary Outcome Measures
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- 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 |
Criteria
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%
Information from the National Library of Medicine
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
Locations
| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| 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:
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Diabetes Kidney transplantation New onset diabetes mellitus after transplantation |
Additional relevant MeSH terms:
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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 |