ClinicalTrialsFinder
Not Yet RecruitingPhase 4ACTRN12613000224729

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

Sponsor

Sydney Local Health District

Enrollment

48 participants

Start Date

Mar 1, 2013

Study Type

Interventional

Conditions

New onset diabetes after transplant

Summary

Diabetes is common after renal transplant and gliclazide is often used as a first line treatment. The objective of the trial is to show that Vildagliptin can be safely used to control hyperglycaemia, with less hypoglycaemic episodes than its comparator of Gliclazide. 48 participants will be randomly allocated to either the intervention arm of oral tablets of 50mg once daily or twice daily of vildalgliptin or to the comparator arm of oral tablet 60mg Gliclazide modified release once daily. The patients will be followed for 16 weeks to assess for hypoglyacaemic episodes and safety.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

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

Exclusion Criteria13

  • Diabetic at time of transplant
  • Less than 3 months post-transplant
  • Treatment with diabetic medications
  • eGFR < 30 ml/min/m2
  • Severe hyperglycemia HbA1c>8.0%
  • Active infection or inflammatory process
  • Unstable cardiac disease
  • Elevated alanine aminotransferase, aspartate aminotransferase, or creatine phosphokinase (more than 2 times upper limit of normal)
  • Inability to give informed consent
  • Pregnancy or breastfeeding, or, woman of child-bearing age not willing to use contraception during the study period
  • 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
  • Patient is unlikely or unable to comply with the visits scheduled in the protocol (e.g. due to excessive travel requirements)
  • Allergy to vildagliptin

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Arm A- Oral Tablet of Vildagliptin 50mg once daily or 50mg twice daily if kidney function is greater than eGFR 60ml/min, for 16 weeks

Arm A- Oral Tablet of Vildagliptin 50mg once daily or 50mg twice daily if kidney function is greater than eGFR 60ml/min, for 16 weeks

Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12613000224729