Diabetes Type 2 with existing cardiovascular disease
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutid
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcuta
Sponsors
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes 2. Serum levels of HbA1c = 7,0% 3. Age = 18 years 4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease or chronic kidney disease of stage III or greater or chronic heart failure of NYHA II or III 5. Written informed consent prior to study participation 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within in the last 4 weeks 3. Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer 4. Renal impairment (eGFR < 30 mL/min) 5. Occurrence of acute vascular events within 6 weeks before screening and randomization 6. Known or suspected hypersensitivity to Liraglutide 7. Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. 8. Lactating females 9. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication. 10. The subject received an investigational drug within 30 days prior to inclusion into this study. 11. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study. 12. The subject is unwilling or unable to follow the procedures outlined in the protocol. 13. The subject is mentally or legally incapacitated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of Liraglutide treatment for 3 months vs. placebo on metabolic profile of patients with type 2 diabetes and existing cardiovascular disease.;Secondary Objective: Effect of Liraglutide treatment for 3 months vs. placebo on left ventricular systolic and diastolic function by echocardiography, energy expenditure and respiratory exchange ratio, the incidence of supraventricular and ventricular arrhythmias (24h holter ECG), systemic low grade inflammation as assessed by cytokine profile and circulating leukocyte populations and microbiome composition in patients with type 2 diabetes and existing cardiovascular disease.;Primary end point(s): Effect of Liraglutide 1.8 mg/d in comparison to placebo after 3 month on the metabolic profile using the discovery HD4 platform, which consists of 4 different methods: 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI.;Timepoint(s) of evaluation of this end point: after 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of Liraglutide in comparison to placebo after 3 months on: - change in left ventricular diastolic function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E by echocardiography - change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume by echocardiography - change in left ventricular systolic function by ejection fraction (EF) by echocardiography - blood pressure - body weight - NT-proBNP - lipid profile - serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, ß-Hydroxybutyrate - Heart rate variability (24 h ECG) - Resting energy expenditure (measured by indirect calorimetry [CardioCoach CO2]) - Respiratory Exchange Ratio (measured by indirect calorimetry [CardioCoach CO2]) - Microbiome analysis by 16S metagenomics sequencing - Albumin excretion by 24 h urine collection - changes in inflammosome analyses assessed by cytokine array - changes in lipidomics analyses, parameters included in the metabolomic profile - changes in circulation inflammatory cell composition (flow cytometry analyses, FACS) - serum and urine samples in addition to blood mononuclear cell pellets are stored for further analyses;Timepoint(s) of evaluation of this end point: after 3 month | — |
Countries
Germany
Contacts
Public ContactCTC-A
University Hospital RWTH Aachen
Outcome results
None listed