E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabète de type 1 traité par pompe à insuline. |
|
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 | 18.0 |
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 |
|
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 |
Comparer l'effet sur l’excursion glycémique de deux stratégies d'injection d’un bolus d’analogue d’insuline rapide: avant ou après le repas |
|
E.2.2 | Secondary objectives of the trial |
Les objectifs secondaires sont :
- étudier le nombre de bolus oubliés, le nombre et l’importance des bolus de correction
- comparer d’autres critères reflets de la glycémie: pic maximum de glycémie, variation (SD, MAGE), HbA1c extrapolée en fonction de la moyenne glycémique, nombre d’hypoglycémies
- comparaison sur un repas-type riche en lipides (60 g) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients majeurs âgés au plus de 65 ans avec diabète de type 1 traités par pompe à insuline. |
|
E.4 | Principal exclusion criteria |
- Déséquilibre de diabète
- Grossesse évolutive connue
- Neuropathie végétative digestive connue
- Pathologie chronique médicale et psychiatrique pouvant influencer l’état du patient et son équilibre glycémique |
|
E.5 End points |
E.5.1 | Primary end point(s) |
AUC de l’enregistrement de la glycémie effectué en continu sur 14 jours, avec baseline à 0,140mg/dl |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- MAGE = mesure de l’instabilité de la glycémie (excès ou défaut de +/- 1 écart-type par rapport à la moyenne).
- AUC sur 4H lors du repas riche en lipides.
- Nombre de bolus oubliés sur chaque période. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | 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) | 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 | 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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Essai en cross-over, le patient est son propre témoin |
|
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |