Differences in endothelial function amongst Sitagliptin and Liraglutide Users: A randomized, open-label, parallel-group and active controlled trial - LAED001

Fundació Clinic per a la Recerca Biomèdica0 sitesJuly 19, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin
Sponsor: Fundació Clinic per a la Recerca Biomèdica
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

July 19, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundació Clinic per a la Recerca Biomèdica

•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

•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.