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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Participants who previously received pioglitazone in the PROactive study (NCT00174993). |
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| Placebo | Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | Participants who previously received Pioglitazone in the PROactive study (NCT00174993). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With First Occurrence of Macro-vascular Event or Death | 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. | Up to Year 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences With Malignancies | 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. | Up to Year 10 |
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Inclusion Criteria:
Exclusion Criteria:
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High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26592506 | Background | Erdmann E, Harding S, Lam H, Perez A. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016 Mar;18(3):266-73. doi: 10.1111/dom.12608. Epub 2016 Jan 8. |
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Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) who were previously treated with pioglitazone or placebo in the PROactive study (NCT00174993) were enrolled in this observational study according to their originally assigned treatment group.
Participants took part at 228 sites in 18 European countries including Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, and the United Kingdom from 02 November 2004 to 10 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| No Intervention | Other | Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993). |
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Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years. |
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| NOT COMPLETED |
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The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study. |
| BG001 | Placebo | Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | Participants |
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| Duration of T2DM | Mean | Standard Deviation | Years |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
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| Body mass index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With First Occurrence of Macro-vascular Event or Death | 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. | The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993). | Posted | Number | percentage of participants | Up to Year 10 |
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| Secondary | Incidences With Malignancies | 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. | The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993). | Posted | Number | percentage of participants | Up to Year 10 |
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Due to the observational nature of the study no safety data other than the monitored outcomes were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study. | 0 | 0 | 0 | 0 | ||
| EG001 | Placebo | Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years. | 0 | 0 | 0 | 0 |
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No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Black |
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| Asian/Oriental |
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| Other |
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| Belgium |
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| Czech Republic |
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| Denmark |
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| Estonia |
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| Finland |
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| France |
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| Germany |
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| Hungary |
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| Latvia |
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| Lithuania |
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| Netherlands |
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| Norway |
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| Poland |
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| Slovakia |
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| Sweden |
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| Switzerland |
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| United Kingdom |
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