Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial

• Conditions: type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000893-68-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2.Male or female patients between 45 and 65 years old
3.Pre-existing type 2 diabetes with HbA1c between 7.0 and 9.5%
4.Triglycerides >1.68 mmol/L
5.HDL cholesterol <1.29 mmol/L in women and <1.04 mmol/L in men
6.Systolic blood pressure (SBP) <130 mmHg and diastolic blood pressure (DBP) <85 mmHg or treatment with antihypertensive agents
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Known or suspected hypersensitivity to trial product(s) or related products
2.Previous participation in this trial. Participation is defined as being randomised.
3.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive, or males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraception
4.Moderate or severe renal dysfunction (creatinine clearance < 60 ml/min)
5.Previous type 2 diabetes treatment apart from metformin or insulin
6.Current smoker or history of smoking within 6 months prior to screening.
7.Evidence of overt cardiovascular disease, (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease).
8.Caffeine intake within 24 hours of endothelial function measurements.
9.Use of any drug with known clinically significant sympathetic or parasympathetic effects, as determined by the Investigator.
10.Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering medication within 4 weeks prior to screening and throughout the day.
11.The receipt of any investigational medicinal product within 6 months prior to screening.
12.Presence of cancer or other significant medical condition
13.Inability to follow verbal or written instructions

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin;Secondary Objective: To assess the effects of a three month treatment with Liraglutide compared to Sitagliptin on other emerging potential cardiovascular risk factors, such as oxidative stress markers, cytokines, and soluble cell adhesion molecules.<br>To compare the safety profile of both treatment groups.;Primary end point(s): The primary endpoint will be comparing the baseline corrected change in endothelial function by flow-mediated vasodilation (FMD) of the brachial artery at 3 months between the treatment arms;Timepoint(s) of evaluation of this end point: Twice: Baseline (To be assessed before first treatment administration) and week 12