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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pioglitazone

Participants who previously received pioglitazone in the PROactive study (NCT00174993).

No Intervention

Intervention Type OTHER

Participants who previously received Pioglitazone in the PROactive study (NCT00174993).

Placebo

Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993).

No Intervention

Intervention Type OTHER

Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).

Interventions

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No Intervention

Participants who previously received Pioglitazone in the PROactive study (NCT00174993).

Intervention Type OTHER

No Intervention

Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

36 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No