Fenofibrate as an Early Treatment Option in Type 1 Diabetes: A clinical trial to evaluate antidiabetic effects of Fenofibrate in patient with newly onset type 1 diabetes.

Phase 1

• Conditions: ewly onset Type 1 Diabetes, with first insulin injection maximum six weeks prior inclusion in this trial; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-004434-41-DK
• Lead Sponsor: Flemming Pociot

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-12
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

Exclusion Criteria

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))

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified