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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: No Intervention

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3599 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pioglitazone
Participants who previously received pioglitazone in the PROactive study (NCT00174993).
Other: No Intervention
Participants who previously received Pioglitazone in the PROactive study (NCT00174993).

Placebo
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   36 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
Additional Information:

Publications:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02678676    
Other Study ID Numbers: AD-4833/EC445
First Posted: February 10, 2016    Key Record Dates
Results First Posted: July 7, 2016
Last Update Posted: July 7, 2016
Last Verified: May 2016
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases