E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Newly onset Type 1 Diabetes, with first insulin injection maximum six weeks prior inclusion in this trial |
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E.1.1.1 | Medical condition in easily understood language |
Patients with newly diagnosed Type 1 Diabetes |
Patienter med nyopdaget type 1 sukkersyge |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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)) |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months after inclusion |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3, 6,12 and 24 months after inclusion |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |