E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects newly diagnosed with type 1 diabetes |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
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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 |
• Investigate the effect of DiaPep277 versus placebo in subjects with Type 1 Diabetes Mellitus (T1D) on endogenous insulin secretion or pancreatic beta cell function as measured by AUC0-120mins calculated from C-peptide concentration vs. time curve of mixed-meal tolerance test (MMTT). |
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E.2.2 | Secondary objectives of the trial |
• Investigate the effect of DiaPep277 on other measurements of endogenous insulin secretion: AUC0-20 calculated from concentration vs. time curve of glucagon-stimulated C-peptide secretion; MMTT and glucagon-stimulated peak C-peptide concentration Cmax, and percent of subjects with Cmax 0.2 nmol/L at end of study. • Investigate the effect of DiaPep277 on percent of subjects that achieve HbA1c≤7%. • Investigate the effect of DiaPep277 on daily insulin dose per body weight at study end • Investigate the effect of DiaPep277 on hypoglycemic event rate • Assess the effect of DiaPep277 on glycemic control according to MAGE calculated from 7 point glucose profile and CGMS data. • Assess the safety and tolerability of DiaPep277 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects between the ages of 20 and 45 years (inclusive) at screening. • A diagnosis of T1D according to the American Diabetes Association and World Health Organization (ADA/WHO) criteria for up to 5 months at screening • A diagnosis of T1D for up to 6 months at randomization (baseline) • Subject has been on insulin since diagnosis of T1D. • Fasting C-peptide levels 0.22 nmol/L and <0.8 nmol/L. • Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GADA, or IAA) • Body mass index (BMI) ≥17 kg/m2 and < 30 kg/m2 at screening |
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E.4 | Principal exclusion criteria |
1 The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject`s response to treatment or the ability to complete the study. 2 The subject has a history of any kind of malignant tumor. 3 The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject`s participation in and/or completion of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Beta cell function: AUC(0-120 min) calculated from concentration vs. time curve of stimulated C-peptide secretion from MMTT, measured by radioimmunoassay (RIA), change from baseline to end of study. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Ultima Visit Ultimo Paziente |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |