N/A
N=3,599
An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02678676 ↗Enrolled (actual)
3,599
Serious AEs
—
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants With First Occurrence of Macro-vascular Event or Death — 58; 60.3 percentage of participants — p=0.3444
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Adult, Older Adult · 36+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With First Occurrence of Macro-vascular Event or Death |
58; 60.3 | 0.3444 |
| SECONDARY Incidences With Malignancies |
12.9; 13.2 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02678676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.