Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000224729
Ethics application status
Approved
Date submitted
21/02/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy and tolerability of Galvus (Vildagliptin) compared to Sulfonylureas in patients with new onset diabetes after transplantation (NODAT)
Scientific title
The efficacy and tolerability of Galvus (Vildagliptin) compared to Sulfonylureas in patients with new onset diabetes after transplantation (NODAT)
Secondary ID [1] 281255 0
Nil
Universal Trial Number (UTN)
Trial acronym
VAT (Vildagliptin after transplant)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
New onset diabetes after transplant 287447 0
Renal Transplant 287448 0
Condition category
Condition code
Metabolic and Endocrine 287786 287786 0 0
Diabetes
Renal and Urogenital 287787 287787 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 285723 0
Treatment: Drugs
Comparator / control treatment
Arm B- Oral tablet Gliclazide Modified release 60mg Once daily, for 16 weeks
Control group
Active

Outcomes
Primary outcome [1] 288008 0
Hypoglycaemic events, defined as blood glucose <3.9 mmol/L (with or without symptoms)
Timepoint [1] 288008 0
0 and 4 months
Secondary outcome [1] 299267 0
1. 24 hour CGM done at baseline and in the last week of each 120 day treatment period to measure the composite endpoints of Vildagliptin compare with sulfonylurea
a. mean afternoon blood glucose (1300 to 1900 pm)
b. percentage time of glucose >11mmol/L
c. percentage time of glucose < 3.9 mmol/L (hypoglycemia)
Timepoint [1] 299267 0
0 and 4 months
Secondary outcome [2] 299268 0
2. Efficacy
a. Difference of glycaemic control markers from baseline to endpoint between Vildagliptin and sulfonylurea arms
1. HbA1c - measured via whole blood assay
2. Fasting Plasma Glucose - measured via a plasma assay
3. Fructosamine - measured via serum assay
b. Difference of fasting insulin (serum assay), c-peptide (serum assay) and glucagon (plasma assay) level from baseline to endpoint between Vidagliptin and sulfonylurea arms
Timepoint [2] 299268 0
0-4 months
Secondary outcome [3] 299269 0
3. Safety
a. Symptomatic episodes of hypoglycaemia
b. BGL confirmed hypoglycaemia (<3.9 mmol/L)
c. eGFR,
d. Urine albumin:creatinine ratio
e. Haemoglobin, white cell count
f. Lipids
g. Liver function tests
h. Biopsy-proven acute rejection
i. Graft loss
j. Immunosuppressive drug levels (tacrolimus etc)
Timepoint [3] 299269 0
0-4 months

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited through file review and direct referral from Nephrologists in the renal transplant outpatient department at Royal Prince Alfred Hospital. After signing the consent form, patients will go into 1 month of screening to ensure stable BGL levels. Patients will then be randomised as per the procedures below. It is not a blinded study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomised 1:1 to each group, stratified by time post-transplant (less than 6 months vs more than 6 months). The randomisation sequence will consist of computer-generated random permuted blocks of size 4-8. The sequence will be stored in numbered, sealed, opaque envelopes. The envelopes will be opened by non-study personnel following successful completion of screening.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 637 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 6370 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 286040 0
Commercial sector/Industry
Name [1] 286040 0
Novartis Pharmaceuticals Pty Ltd
Country [1] 286040 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
Level 11 , KGV Building,
Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 284854 0
None
Name [1] 284854 0
Address [1] 284854 0
Country [1] 284854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288087 0
The SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 288087 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 288087 0
Australia
Date submitted for ethics approval [1] 288087 0
Approval date [1] 288087 0
18/12/2012
Ethics approval number [1] 288087 0
X12-0306

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34729 0
Prof Steven Chadban
Address 34729 0
Renal Medicine
Level 6 West
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Country 34729 0
Australia
Phone 34729 0
+61 2 9515 6600
Fax 34729 0
+61 2 9515 6329
Email 34729 0
[email protected]
Contact person for public queries
Name 17976 0
Georgia Whitman
Address 17976 0
Transplant Ambulatory Care
Lvl 9, Building 89
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 17976 0
Australia
Phone 17976 0
+61 2 9515 7618
Fax 17976 0
+61 2 9515 6329
Email 17976 0
[email protected]
Contact person for scientific queries
Name 8904 0
Steve Chadban
Address 8904 0
Renal Medicine
Level 6 West
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Country 8904 0
Australia
Phone 8904 0
+61 2 9515 6600
Fax 8904 0
+61 2 9515 6329
Email 8904 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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