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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|ClinicalTrials.gov Identifier: NCT02678676|
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : July 7, 2016
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: No Intervention|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||3599 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications.|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Participants who previously received pioglitazone in the PROactive study (NCT00174993).
Other: No Intervention
Participants who previously received Pioglitazone in the PROactive study (NCT00174993).
Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993).
Other: No Intervention
Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).
- Percentage of Participants With First Occurrence of Macro-vascular Event or Death [ Time Frame: 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.
- Incidences With Malignancies [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678676
|Study Director:||Medical Director||Takeda|