Fenofibrate as an Early Treatment Option in Type 1 Diabetes: A randomized, double-blind, placebo-controlled, trial to evaluate antidiabetic effects of Fenofibrate in patient with newly onset type 1 diabetes.

Flemming Pociot0 个研究点目标入组 58 人开始时间: 2019年12月12日最近更新: 2020年4月29日

试验速览

暂无简介。

•1.Diagnosed T1D (E10.9) and aged 16 to 46 years old at inclusion.
•2.First injection of insulin maximum six weeks prior to inclusion.
•3.Must be willing and capable of taking the study drugs and meet for tests as described in the protocol.
•4.Signed informed consent and expected cooperation of the patient for the treatment and follow up must be obtained and documented according to the guidelines for good clinical practice (GCP) and Danish regulations.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 48
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Treatment with any oral or injected anti-diabetic medications other than insulin.
•2.A medical history of liver disease, pancreatitis, kidney disease, myositis, or venous thromboembolic events
•3.Participation in interventional or other drug research studies which could affect the objectives of this study.
•4.Inability or unwillingness to comply with the provisions of this protocol.
•5.Females who are lactating, pregnant or planning to become pregnant within 12 months after inclusion. Males or fertile women not willing to use adequate contraception, if sexually active
•6.Presence of serious disease or condition, which in the opinion of the Investigator makes the patient non-eligible for the study.
•7.C-peptide levels < 0.2 nmol/L upon inclusion measured during a mixed meal tolerance test (MMTT)
•8.Absence of islet autoantibody (Glutamic acid decarboxylase-65 antibodies (GAD65), Insulin antibodies (IAA), Islet antigen-2 antibodies (IA-2) or Zinc Transporter 8 antibodies (ZnT8))

发起方

Flemming Pociot