None listed
Conditions
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.
Interventions
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.
Sponsors
Associate Professor Seng Khee Gan
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed