Newly onset Type 1 Diabetes, with first insulin injection maximum six weeks prior inclusion in this trial MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Fenofibrat Heumann 160 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
Flemming Pociot
Eligibility
Sex/Gender
All
Inclusion criteria
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
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))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if chronic treatment with Fenofibrate in therapeutic doses will stop disease progression and improve residual insulin production in patient with newly onset T1D.;Secondary Objective: Not applicable;Primary end point(s): Change in mean residual insulin secretion measured by C-peptide area under the curve after a 2 hours Mixed Meal Tolerance Test, 12 months after initiation of trial treatment;Timepoint(s) of evaluation of this end point: 12 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in mean residual insulin secretion measured by stimulated Cpeptide after 1, 3, and 6 months of treatment and 12 months after end of treatment (24 months after inclusion). 2. Proportion of patients with peak stimulated C-peptide > 0.2 nmol/L 4. Changes in mean insulin dosage in units per kilo bodyweight for 24 hours one week before each trial visit. 5. HbA1c at every trial visit. Both the absolute level and the change from visit 1 will be analysed. 6. Number of hypoglycaemic events since last visit, and the total number of events after 12 months of treatment with trial medication. 7. Changes in Model-estimated beta cell function 8. Proinsulin/c-peptide ratio in serum as a measure of beta-cell stress;Timepoint(s) of evaluation of this end point: 1, 3, 6,12 and 24 months after inclusion | — |
Countries
Denmark
Contacts
Public ContactFlemming Pociot
Flemming Pociot
Outcome results
None listed