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

International follow-up study, after the investigational drug exposure in diabetic patients previously included in the REGULATE trial (benfluorex versus pioglitazone).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001283-22-CZ

Enrollment

361

Registered

2011-06-09

Start date

2011-07-13

Completion date

Unknown

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
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, - 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).	—

Measure

Time frame

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, - 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

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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.

—

Countries

Argentina, Czech Republic, Germany, India, South Africa, Tunisia

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier (I.R.I.S.)

clinicaltrials@servier.com+33155 72 70 63

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026