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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000224729

Acronym

VAT (Vildagliptin after transplant)

Enrollment

Registered

2013-02-25

Start date

2013-03-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results