E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type II diabetes
The medical condition investigated in the REGULATE trial (CL3-00780-148) was type II diabetes. The applied CL3-00780-150 trial, REGULATE follow-up study, is thus performed in diabetic patients. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 document the clinical condition of patients who were included in the REGULATE trial and exposed to the investigational drugs (benfluorex or pioglitazone). |
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E.2.2 | Secondary objectives of the trial |
- Description of the cardiac condition evolution of the patients who were included in the REGULATE trial,
- Assessment of the between-group global safety condition. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All the patients included in the REGULATE trial (CL3-00780-148) who were exposed to one of the study drugs |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Emergence of valvular abnormalities between REGULATE baseline and follow-up visits with a central reading of a transthoracic echocardiogram |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The safety measurements will be done during one single visit at investigator's site (FU-VISIT). |
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E.5.2 | Secondary end point(s) |
-Evolution of valvular abnormalities between the end of REGULATE participation and follow-up visit,
-Other transthoracic echocardiography findings including pulmonary hypertension between the end of REGULATE participation and follow-up visit,
-Medical events including hospitalisations between the end of REGULATE participation and follow-up visit,
-Physical and cardiac examinations,
-Mortality rate since the start of REGULATE trial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
One visit per patient is planned. The cardiological examination will be done in a time-window of 6 weeks and / or the biological sampling will be done in a time-window of 7 days. |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Safety follow-up without treatment administration |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Safety follow-up without treatment administration |
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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.8.2.4 | Number of treatment arms in the trial | 0 |
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 155 |
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 | No |
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 |
Argentina |
India |
South Africa |
Tunisia |
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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
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The last visit of the last participant is considered as the end of trial.
One visit per patient is planned (FU-VISIT) with all data collected and exams performed within the defined time-windows associated to the FU-VISIT. According to the patient's wish, an additional appointment can be planned with the investigator for a shared review of the examination's results and conclusions. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |