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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No Intervention

• Registration Number: NCT02678676
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2016-02-07
• Study First Submitted QC: 2016-02-07
• Study First Posted: 2016-02-10
• Status Verified: 2016-05
• Results First Submitted: 2016-05-30
• Results First Submitted QC: 2016-05-30
• Last Update Submitted: 2016-05-30
• Results First Posted: 2016-07-07
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3599

Inclusion Criteria

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

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Exclusion Criteria

• There were no exclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With First Occurrence of Macro-vascular Event or Death	Up to Year 10	The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.

Secondary Outcome Measures

Name	Time	Method
Incidences With Malignancies	Up to Year 10	Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.