Type 2 diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Given written informed consent 2) Male or female patients >50 years with type 2 diabetes (WHO criteria) 3) HbA1c = 48 mmol/mol (6.5 %) 4) eGFR = 30 ml/min/1.73 m2 (estimated by CKD-epi formula) 5) Stable glucose-lowering medication for at least 4 weeks before the baseline PET/CT (excluding oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and other agents, which in the investigator’s opinion could interfere with the effect of liraglutide) 6) Stable/no treatment of hypercholesterolemia 4 weeks before baseline PET/CT 7) Must be able to communicate with the investigator and understand informed consent. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes mellitus 2) Chronic pancreatitis / previous acute pancreatitis 3) Known or suspected hypersensitivity to trial product(s) or related products 4) Treatment 90 days prior to screening with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and other agents, which in the investigator’s opinion could interfere with the effect of liraglutide 5) Cancer or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial 6) Clinical signs of diabetic gastroparesis 7) Previous bowel resection 8) Impaired liver function (transaminases > two times upper reference levels) 9) Inflammatory bowel disease 10) Weight >150 kg 11) Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods 12) Known or suspected abuse of alcohol or narcotics 13) Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to determine whether 6 months Liraglutide treatment is associated with improvement in atherosclerotic phenotype through anti-inflammatory effects compared to placebo. ;Secondary Objective: Possible mechanisms causing the anti-atherosclerotic effect will be explored.;Primary end point(s): The effect of Liraglutide on vascular inflammation, assessed by FDG-PET/CT.;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 26 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints includes: 1) The effect of Liraglutide treatment on endothelial dysfunction, assessed with endo-PAT and sublingual glycocalyx measurement. 2) The effect of Liraglutide treatment on coronary artery calcium score 3) The effect of Liraglutide treatment on carotid intima media thickness 4) The effect of Liraglutide treatment on circulating biomarkers of atherosclerosis 5) The effect of Liraglutide treatment on peripheral blood mononuclear cell gene expression Exploratory endpoints: 1) Agreement between the 64Cu-DOTATATE PET/CT and the FDG PET/CT examination for evaluation of vascular inflammation. 2) Change from baseline to week 26 in vascular inflammation, assessed by 64Cu-DOTATATE. ;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 26 weeks of treatment. | — |
Countries
Denmark
Contacts
Public ContactPeter Rossing
Steno Diabetes Center Copenhagen
Outcome results
None listed