The efficacy and tolerability of Galvus (Vildagliptin) compared to Sulfonylureas in patients with new onset diabetes after transplantation (NODAT)

Phase 4

• Conditions: ew onset diabetes after transplant; Renal Transplant; New onset diabetes after transplant; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613000224729
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1.Renal transplant recipient
2.Adult (18 years or older)
3.New Onset Diabetes After Transplant (OGTT or random or fasting BSL > WHO recommendation)
4.HbA1c <8.0%

Exclusion Criteria

1.Diabetic at time of transplant
2.Less than 3 months post-transplant
3.Treatment with diabetic medications
4.eGFR < 30 ml/min/m2
5.Severe hyperglycemia HbA1c>8.0%
6.Active infection or inflammatory process
7.Unstable cardiac disease
8.Elevated alanine aminotransferase, aspartate aminotransferase, or creatine phosphokinase (more than 2 times upper limit of normal)
9.Inability to give informed consent
10.Pregnancy or breastfeeding, or, woman of child-bearing age not willing to use contraception during the study period
11.Patient is participating or has participated in another clinical trial and/or is taking or has taken an investigational drug in the past 28 days
12.Patient is unlikely or unable to comply with the visits scheduled in the protocol (e.g. due to excessive travel requirements)
13.Exclusion criteria will comply with local label product information sheet
14.Allergy to vildagliptin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoglycaemic events, defined as blood glucose <3.9 mmol/L (with or without symptoms)[0 and 4 months]