type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin
Conditions
Interventions
Trade Name: Liraglutide (Victoza®)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Fundació Clinic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will include comparing the baseline corrected change of the following cardiovascular risk factors at 3 months between the treatment arms: Serum biomarkers: apolipoprotein A1, apolipoprotein B, levels of oxidized low-density lipoprotein (ox-LDL), soluble vascular cell adhesion molecule (VCAM), high sensitive C-reactive protein (hsCRP), interleukin 6 (IL-6) Measures of oxidative stress: nitrotyrosine, urinary free 8-iso prostaglandin F2 alpha (8-iso PGF2alpha) Global measure of glucose instability, particularly of postprandial hyperglycemia: 1,5-anhydroglucitol Lipids: Plasma total cholesterol, plasma high density lipoprotein-cholesterol (HDL-cholesterol), direct plasma low density lipoprotein-cholesterol (LDL-cholesterol), plasma triglyceride levels, free fatty acids Weight Systemic blood pressure Glycemic control parameters: fasting glucose, fasting insulin, haemoglobin A1c (HbA1c), 7 point glucose self monitored;Timepoint(s) of evaluation of this end point: Serum biomarkers, Measures of oxidative stress and Glycemic control parameters: Twice, Baseline (To be assessed before first treatment administration) and week 12. Weight, Systemic blood pressure and Lipids: 3 times, screening visit, baseline and week 12. | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
Clinical Trials Unit (Hospital Clínic)
Outcome results
None listed