Patients with Diabetes type 2.
Conditions
Interventions
Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
Ana M. Wägner
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Type 2 diabetes treated with oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate-long acting insulin injections per day or a combination of both. -HbA1c between 7 and 10 %. 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Severe renal failure (estimated CFR 6 points) Present or planned pregnancy/breastfeeding or inadequate contraception intolerance/allergy to liraglutide Familiar/personal history of medullary thyroid cancer or multiple endocrine neoplasia 2 personal history of pancreatitis triglyceride concentrations above 500mg/dl or alcohol intake>40 grams/day known active malignancy tratment with GLP1 agonist or DPP4 inhibitors in the previous 3 months factors potentially interfering with adherence to treatment or follow-up (investigator´s criteria) known coronary artery disease with exercise-induced ischaemia planned revascularisations in the following 6 months severe symptoms of heart failure (NYHA class IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to assess the effect pf a GLP1 agonist on clinically relevant measures of myocardial function.;Secondary Objective: Distance covered during a 6 minute walk test. Left ventricular function parameters (ecocardiography). Diastolic function (ecocardiography) Total number of steps in 24 hours, registered by Holter. Quality of life questionnaires. HbA1c amd total daily insulin dose. Lipids nd apoB CRP ProBNP Fasting C peptide Daily medication Body weight, waist circumference and BMI;Primary end point(s): Fitness, assessed as maximum oxygen comsumption (VO2 max) on a cycle ergometer test.;Timepoint(s) of evaluation of this end point: Baseline and 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Distance covered during a 6 minute walk test. left ventricular function parameters. Diastolic function. Total number of steps in 24 hours, registered by Holter. Quality of life questionnaires. HbA1c amd total daily insulin dose. Lipids nd apoB CRP ProBNP Fasting C peptide Daily medication Body weight, waist circumference and BMI;Timepoint(s) of evaluation of this end point: Baseline and 26 weeks and 12 weeks for some measurementes | — |
Countries
Spain
Contacts
Public ContactDavid Valido
CRAnarias Investigación y Desarrollo, S.L.
Outcome results
None listed