Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Actos Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
3 other identifiers
observational
1,067
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2014
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedMarch 12, 2019
February 1, 2019
4.9 years
February 19, 2014
July 13, 2017
March 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Up to Week 52
Secondary Outcomes (6)
Change From Baseline in Fasting Blood Glucose
Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Fasting Triglycerides
Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in HDL Cholesterol
Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in LDL Cholesterol
Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
- +1 more secondary outcomes
Study Arms (1)
Pioglitazone
Pioglitazone 15 mg to 30 mg, orally, once daily
Interventions
Eligibility Criteria
Type 2 diabetes mellitus
You may qualify if:
- Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.
- Participants treated with an insulin product for at least 4 weeks
- Participants who started Actos Tablets for the first time after the start of an insulin product
- Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
You may not qualify if:
- Participants with contraindications to Actos Tables and insulin products treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 21, 2014
Study Start
July 30, 2009
Primary Completion
June 30, 2014
Study Completion
June 30, 2014
Last Updated
March 12, 2019
Results First Posted
February 18, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.