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

Sydney Local Health District0 个研究点目标入组 48 人开始时间: 2013年2月25日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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%

•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

发起方