Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes

• Status: Completed
• Trial end date: 2019-08-16
• Target enrollment: 0
• Participant gender: All

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 patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period of 26 weeks or placebo for 26 weeks.

The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborator: Department of Clinical Physiology, Nuclear Medicine & PET, Rigshospitalet & Cluster for Molecular Imaging, University of Copenhagen, Denmark
• Treatments: Liraglutide

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 (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

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.

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