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.

Phase 4

Withdrawn

• Conditions: Type 2 Diabetes; Hypertriglyceridaemia; Metabolic and Endocrine - Diabetes; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12611000992909
• Lead Sponsor: Associate Professor Seng Khee Gan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified