Effect of liraglutide on vascular inflammation in type-2 diabetes: A randomized, placebo-controlled, double-blind, parallel clinical PET/CT trial - The Liraflame Trial

Steno Diabetes Center Copenhagen0 个研究点目标入组 100 人开始时间: 2016年11月2日最近更新: 2020年7月20日

试验速览

暂无简介。

•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

•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

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