Effect of Liraglutide on lipid synthesis and metabolism after mixed meal. Asingle-center randomized controlled study.

• Conditions: Type 2 diabetes; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-005075-40-FI
• Lead Sponsor: Research Programs' Unit, Diabetes & Obesity, University of Helsinki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-03
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Obese subjects with T2D and a large waist (waist > 88 cm in women and > 92 cm in men, BMI 27–40 kg/m2, triglycerides between 1.0 – 4.0 mmol/L and LDL < 4.5 mmol/l) treated with a lifestyle or metformin (any dose) (HbA1c 6.5-9% ) and aged 30 – 75 years will be included. Subjects may or may not use statins
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

?Type 1 diabetes
?Apo E2/2 phenotype
?ALT/AST > 3x ULN
?GFR < 60 ml/min, clinically significant TSH outside normal range
?Lipid-lowering drugs other than statins within 6 months
?Treatment with pioglitazone, insulin, sulphonylureas, gliptines, glinides, SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day) within 6 months
?Blood pressure > 160 mmHg systolic and/or > 105 diastolic
?History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism
?Any medical condition that puts the patient in the risk of dehydration
?Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
?Females of childbearing potential who are not using adequate contraceptive methods
?Subjects who have experienced side-effects previously from GLP-1 agonists
?Non-compliance or withdrawal of consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified