Follow-up trial with no study drug prescription in diabetic patients previously included in the REGULATE trial.

Conditions: 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.
MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-001283-22-CZ

Lead Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 361

Inclusion Criteria

All the patients included in the REGULATE trial (CL3-00780-148) who were exposed to one of the study drugs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 599
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 246

Exclusion Criteria

Not applicable

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To document the clinical condition of patients who were included in the REGULATE trial and exposed to the investigational drugs (benfluorex or pioglitazone).;Secondary Objective: - Description of the cardiac condition evolution of the patients who were included in the REGULATE trial,<br>- Assessment of the between-group global safety condition.;Primary end point(s): Emergence of valvular abnormalities between REGULATE baseline and follow-up visits with a central reading of a transthoracic echocardiogram;Timepoint(s) of evaluation of this end point: The safety measurements will be done during one single visit at investigator's site (FU-VISIT).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Evolution of valvular abnormalities between the end of REGULATE participation and follow-up visit,<br>-Other transthoracic echocardiography findings including pulmonary hypertension between the end of REGULATE participation and follow-up visit, <br>-Medical events including hospitalisations between the end of REGULATE participation and follow-up visit,<br>-Physical and cardiac examinations,<br>-Mortality rate since the start of REGULATE trial.;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.