Status:
COMPLETED
Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Department of Clinical Physiology, Nuclear Medicine & PET, Rigshospitalet & Cluster for Molecular Imaging, University of Copenhagen, Denmark
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects of liraglutide. In a randomized, placebo-controlled, double-blind, parallel trial we will included 100 pat...
Detailed Description
Despite multifactorial treatment patients with type 2 diabetes are still at high risk of cardiovascular disease. The clinical LEADER trial demonstrated a reduction in cardiovascular events in patients...
Eligibility Criteria
Inclusion
- Given written informed consent
- Male or female patients \>50 years with type 2 diabetes (WHO criteria)
- HbA1c ≥ 48 mmol/mol (6.5 %)
- eGFR ≥ 30 ml/min/1.73 m2 (estimated by CKD-epi formula)
- Stable glucose-lowering medication (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)for at least 4 weeks before the baseline PET/CT
- Stable/no treatment of hypercholesterolemia 4 weeks before baseline PET/CT
- Must be able to communicate with the investigator and understand informed consent.
Exclusion
- Type 1 diabetes mellitus
- Chronic pancreatitis / previous acute pancreatitis
- Known or suspected hypersensitivity to trial product(s) or related products
- 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
- 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
- Clinical signs of diabetic gastroparesis
- Previous bowel resection
- Impaired liver function (transaminases \> two times upper reference levels)
- Inflammatory bowel disease
- Weight \>150 kg
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- Known or suspected abuse of alcohol or narcotics
- Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Key Trial Info
Start Date :
October 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03449654
Start Date
October 26 2017
End Date
August 16 2019
Last Update
June 11 2020
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820