Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000992909
Ethics application status
Approved
Date submitted
30/08/2011
Date registered
16/09/2011
Date last updated
29/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Galvus on post-meal artery function and triglyceride levels in Type 2 diabetic individuals with high triglyceride levels who are on a statin medication.
Scientific title
The effect of Galvus (vildagliptin) on post-prandial endothelial function and post-prandial hypertriglyceridaemia in individuals with Type 2 diabetes and fasting hypertriglyceridaemia, treated with statins.
Secondary ID [1] 262863 0
Nil
Universal Trial Number (UTN)
U1111-1123-8144
Trial acronym
VIPER Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 270581 0
Hypertriglyceridaemia 270582 0
Condition category
Condition code
Metabolic and Endocrine 270748 270748 0 0
Diabetes
Cardiovascular 270749 270749 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
vildagliptin 50mg oral tablet twice daily for 6 weeks.

The wash out period between the two treatment arms is 6 weeks.

During the study period participants will continue with their usual metformin and statin treatments.
Intervention code [1] 269211 0
Treatment: Drugs
Comparator / control treatment
Placebo replica oral tablet without the active ingredient, twice daily for 6 weeks.


The wash out period between the two treatment arms is 6 weeks.


During the study period participants will continue with their usual metformin and statin treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 279445 0
AUC and incremental AUC for serum triglycerides following standardised fat meal which contains 129 grams of fat.
Timepoint [1] 279445 0
At the Week 6 and Week 18 Visits AUC and incremental AUC for serum triglycerides following a standardised fat meal will be assessed at timepoints 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420 and 480 minutes
Primary outcome [2] 279446 0
Peak post-ischaemic forearm blood flow and post-ischaemic flow debt repayment, measured by forearm plethysmography.
Timepoint [2] 279446 0
At the Week 6 and Week 18 Visits Peak post-ischaemic forearm blood flow and post-ischaemic flow debt repayment, measured by forearm plethysmography will be measured at timepoints 0 and 4 hours post a standardised fat meal.
Secondary outcome [1] 287663 0
AUC and incremental AUC for serum apoB48, apoB100, glucose, insulin, cholesterol and free fatty acids following standardized fat meal.
Timepoint [1] 287663 0
At the Week 6 and Week 18 Visits AUC and incremental AUC for serum apoB48, apoB100, glucose, insulin, cholesterol and free fatty acids following standardized fat meal will be assessed at timepoints 0, 120, 240, 360 and 480 minutes

Eligibility
Key inclusion criteria
Outpatients with Type 2 diabetes on metformin treatment only (at doses 500mg to 1000mg twice daily).
HbA1c < 8%.
Already treated with a statin for at least 6 weeks with LDL cholesterol<2.5 mmol/L.
Hypertriglyceridaemia (Triglycerides > 1.7 mmol/L) on a random blood sample.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with other oral diabetes medications other than metformin.
Treatment with insulin or exenatide.
HbA1c > 8%.
Treatment with fibrates.
Premenopausal females. Menopause is defined as 12 consecutive months without menstruation. If menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 30 mIU/ml must be documented.
Primary dyslipidaemia, including the E2/E2 genotype.
Type III dyslipedaemia.
Uncontrollable hypertension: resting BP > 150/90.
Consumption of > 30g alcohol per week.
Tobacco smoking.
Significantly abnormal liver function (ALT or AST > 3 times ULN).
Creatine kinase > 3 x ULN.
Creatinaemia (> 150 micromols).
Macroproteinuria.
Significantly abnormal thyroid function.
Atrial fibrillation or significant dysrythmia.
Cardiovascular event in the last 6 months.
Anaemia.
Gastric disorders.
Any other serious medical / systemic illness (e.g cancer).
Use of steroids or other medications that may affect lipid metabolism.
Psychiatric illness.
Allergies to eggs, cream, milk.
Likelihood of poor compliance to the study.
Likelihood of not completing the study.

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)
Type 2 diabetes who fulfill the selection criteria will be randomly allocated to one of two sequence groups (Group A and B).


Allocation will be concealed from study staff.

Allocation involves contacting the person holding the allocation schedule who is not involved in the study.


Group A will be treated with vildagliptin in addition to Metformin and Statin medications for a 6 week treatment period, followed by 6 weeks washout period, then followed by treatment with placebo in addition to Metformin and Statin medication for a 6 week treatment period.


Group B will be treated with placebo in addition to Metformin and Statin medications for a 6 week treatment period, followed by 6 weeks washout period, then followed by treatment with valdagliptin in addition to Metformin and Statin medication for a 6 week treatment period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised sequence generated by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
29/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4361 0
6000-6250

Funding & Sponsors
Funding source category [1] 269679 0
University
Name [1] 269679 0
University of Western Australia
Country [1] 269679 0
Australia
Funding source category [2] 269680 0
Commercial sector/Industry
Name [2] 269680 0
Novartis Pharmaceuticals Australia Pty Limited
Country [2] 269680 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Seng Khee Gan
Address
University of Western Australia
School of Medicine and Pharmacology, Royal Perth Hospital
Level 4, MRF Building
50 (rear) Murray Street,
Perth. 6000
Western Australia
Country
Australia
Secondary sponsor category [1] 268717 0
Hospital
Name [1] 268717 0
Royal Perth Hospital
Address [1] 268717 0
Wellington Street
Perth. 6000
Western Australia
Country [1] 268717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271632 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 271632 0
Level 5, Colonial House
Royal Perth Hospital
Murray Street,
Perth. 6000
Western Australia
Ethics committee country [1] 271632 0
Australia
Date submitted for ethics approval [1] 271632 0
Approval date [1] 271632 0
Ethics approval number [1] 271632 0

Summary
Brief summary
Cardiovascular disease is a common major complication in patients with Type 2 diabetes. People with Type 2 diabetes have abnormal blood fat levels which contribute to this risk of heart disease, particularly high triglycerides, low HDL (good) cholesterol and high small dense LDL (bad) cholesterol. Cholesterol lowering medications called ‘statins’ are widely used to treat this abnormal blood fat metabolism found in Type 2 diabetes. Cholesterol guidelines advise that the LDL-cholesterol be treated to a level of less than 2.5mmol/L. However, more than 30% of patients with Type 2 diabetes continue to have high triglycerides at levels greater than 1.7mmol/L even when their LDL-cholesterol is treated to less than 2.5mmol/L. These patients with high triglyceride levels remain at higher risk of cardiovascular disease despite the statin therapy.

Vildagliptin is used to lower blood sugar in patients with Type 2 diabetes. It belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) and is effective in lowering post-meal blood sugar levels. Current evidence suggests that vildagliptin lowers post-meal blood triglyceride levels in patients with Type 2 diabetes not taking statin therapy. It is not known whether vildagliptin improves artery function (a marker of risk of cardiovascular disease) in people with Type 2 diabetes. It is proposed that, for the group of patients with Type 2 diabetes and high blood triglyceride levels despite statin treatment, an improvement of artery function could occur concurrently with improvement of post-meal blood triglyceride levels with vildagliptin treatment. Thus, vildagliptin may help reduce the high risk of future cardiovascular disease in this group of patients.

The aim of this study is to examine the effect of vildagliptin on post-meal blood fat levels and post-meal artery function in patients with type 2 diabetes and high blood triglyceride levels despite taking statins. Participating patients will already be receiving metformin to control blood sugar.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33037 0
Address 33037 0
Country 33037 0
Phone 33037 0
Fax 33037 0
Email 33037 0
Contact person for public queries
Name 16284 0
Laurie Kear
Address 16284 0
University of Western Australia
School of Medicine and Pharmacology
Royal Perth Hospital
Level 3, MRF Building
50 (rear) Murray Street,
Perth. 6000
Western Australia
Country 16284 0
Australia
Phone 16284 0
+61, 8, 92240390
Fax 16284 0
+61, 8, 92240243
Email 16284 0
[email protected]
Contact person for scientific queries
Name 7212 0
A/Prof. Seng Khee Gan
Address 7212 0
University of Western Australia
School of Medicine and Pharmacology
Royal Perth Hospital
Level 4, MRF Building
50 (rear) Murray Street,
Perth. 6000
Western Australia
Country 7212 0
Australia
Phone 7212 0
+61, 8 92240256
Fax 7212 0
+61, 8, 92240246
Email 7212 0
[email protected]

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No Supporting Document Provided



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