E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 & Type 2 diabetes mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
|
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 assess the pharmacokinetic profile of FDKP following dosing with T/I, evaluated by AUC0-4h of serum FDKP after a meal challenge during active symptomatic URI compared with post-resolution URI. |
|
E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetic profile of serum insulin following dosingwith T/I, evaluated by AUC0-4h of serum insulin, C-peptide after a meal challenge, and safety of T/I as measured by blood glucose levels after a meal challenge including Cmax and Cmin of blood glucose, clinically significant findings from vital signs and abbreviated physical examinations, and adverse effects, during active symptomatic URI, compared with post-resolution URI. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must be active participants in the MKC-TI-030 trial and randomized to treatment with T/I; and
Clinical diagnosis of upper respiratory tract infection (URI) defined as a subject having at least 3 URI symptoms, as defined in Appendix A, within the 24 hours prior to clinic visit and/or on the day of clinic visit. |
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E.4 | Principal exclusion criteria |
Prior participation in MKC-TI-112 trial; and
Evidence by medical history, physical examination or laboratory findings, in the opinion of the PI, suggestive of acute bacterial infection, including but not limited to, purulent sputum production, purulent nasal/eye/ear discharge, chest exam abnormalities to auscultation or percussion, throat exudates, CXR findings of pneumonia (if clinically indicated).
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic Variable: Serum FDKP AUC0-4hr in diabetic subjects with active, symptomatic upper respiratory infection treated with T/I versus FDKP AUC0-4hr from the same subjects, treated with T/I, after resolution of respiratory infection symptons; the subjects will serve as their own controls. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |