Vildagliptin in New Onset Diabetes After Transplantation (ViNODAT). A double-blind, randomized, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014405-14-AT

Enrollment

Unknown

Registered

2009-08-11

Start date

2009-08-27

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

new onset diabetes mellitus after transplantation

Interventions

Trade Name: Galvus ® Product Name: NOVARTIS EUROPHARM LTD / GB Pharmaceutical Form: Tablet INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901-16-5 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Newly diagnosed NODAT as defined by a pathologic OGTT (2h, 75mg glucose): glucose = 200mg/dl - Age > 18 years - Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression of our center, consisting of tacrolimus or cyclosporine A, mycophenolate mofetil, and prednisone triple therapy without any induction - Stable graft function for more than 6 months post transplant - Informed consent of the patient and willingness/ability to follow the instructions of the study team Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with prior history of type 1 or type 2 diabetes - BMI > 40 - Pregnancy (ß-HCG in blood will be measured in all female study participants before enrollment) - severe renal impairment (GFR < 30 ML/min./1.73 m2)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether monotherapy with Vildagliptin improves glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start. Patients will take study medications 30 minutes before OGTT. ;Secondary Objective: • To assess differences in the change in HbA1c after 3 months after treatment start. • To assess differences in the fasting plasma glucose after 3 months after treatment start. • To assess the difference in insulin secretory capacity and insulin sensitivity in both groups after 3 months after treatment start. • To assess the safety and efficacy of Vildagliptin in renal transplanted patients. • To assess the long-lasting effect of Vildagliptin after 3 month treatment, as judged in OGTT 4 weeks after treatment stop. ;Primary end point(s): • Primary endpoint will be the difference in the performance at an OGTT (2h, 75g Glucose) on day 90 after study start compared to baseline.	—

Measure

Time frame

Main Objective: To assess whether monotherapy with Vildagliptin improves glycemic control in kidney transplanted patients with newly diagnosed NODAT as judged in OGTT 3 months after treatment start. Patients will take study medications 30 minutes before OGTT. ;Secondary Objective: • To assess differences in the change in HbA1c after 3 months after treatment start. • To assess differences in the fasting plasma glucose after 3 months after treatment start. • To assess the difference in insulin secretory capacity and insulin sensitivity in both groups after 3 months after treatment start. • To assess the safety and efficacy of Vildagliptin in renal transplanted patients. • To assess the long-lasting effect of Vildagliptin after 3 month treatment, as judged in OGTT 4 weeks after treatment stop. ;Primary end point(s): • Primary endpoint will be the difference in the performance at an OGTT (2h, 75g Glucose) on day 90 after study start compared to baseline.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026