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FOLLOW UP study for patients previously included in REGULATE study.

International Follow Up study, after the investigational drug exposure in diabetic patients previously included in the REGULATE trial (Benfluorex Vs Pioglitazone) - Regulate FU

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/11/002144
Enrollment
845
Registered
2011-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

None listed

Interventions

None listed

Sponsors

Institut de recherches Internationales Servier
Lead Sponsor
Serdia Pharmaceuticals India Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All the patients exposed to one of the study drugs during the REGULATE trial who agree to participate in the follow-up study or who give written authorisation to the investigator for the medical data collection despite their incapacity to visit the investigating site will be included.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
International follow-up study without a study treatment administration; safety profiles in both treatment groups from REGULATE trial (benfluorex Vs Pioglitazone) will be assessed. The main assessment criteria will be the emergence of valvular abnormalities between REGULATE baseline and follow-up visit. For this, the central readers will follow the recommendations described by the American Society of echocardiography report in grading regurgitation severity. Timepoint: International follow-up study without a study treatment administration; safety profiles in both treatment groups from REGULATE trial (benfluorex Vs Pioglitazone) will be assessed. The main assessment criteria will be the emergence of valvular abnormalities between REGULATE baseline and follow-up visit. For this, the central readers will follow the recommendations described by the American Society of echocardiography report in grading regurgitation severity.—

Secondary

MeasureTime frame
- The evolution of valvular abnormalities since the end of REGULATE trial, - Other transthoracic echocardiography findings including pulmonary hypertension since the end of REGULATE trial, - Medical events including hospitalizations since the end of REGULATE trial, - Mortality rate since the start of REGULATE trial. Timepoint: 0 week and 6 weeks—

Countries

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

Contacts

Public ContactDr Manjusha Rajarshi

Serdia Pharmaceuticals (India) Pvt. Ltd.

ajaykumar.yadav@in.netgrs.com022-24162727

Outcome results

None listed

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