An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications

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Takeda

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: No Intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT02678676
AD-4833/EC445

Details and patient eligibility

About

The purpose of this study was to investigate the mortality and macrovascular morbidity as well as the incidence of malignancies over time, in high-risk diabetic participants who previously received long-term treatment with either pioglitazone or placebo in combination with their usual medication for glycaemic management.

Full description

This was a European,multicenter,observational study of participants who were previously treated with pioglitazone or placebo in addition to their existing anti diabetic medication. This 10-year observational study was conducted as a follow-up of PROactive study (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed by this protocol and participants will be managed in accordance with normal medical practice.The planned total duration of the study was 10 years,with data being analyzed and reported every 2 years.Participants were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.

Enrollment

3,599 patients

Sex

All

Ages

36 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of the final visit of the PROactive Study (NCT00174993).
  • Willingness and ability to give written informed consent for the observational study.

Exclusion criteria

  • There were no exclusion criteria.

Trial design

3,599 participants in 2 patient groups

Pioglitazone
Description:
Participants who previously received pioglitazone in the PROactive study (NCT00174993).
Treatment:
Other: No Intervention
Placebo
Description:
Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993).
Treatment:
Other: No Intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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