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Clinical Trial Details

Trial ID: L4779
Source ID: NCT02068508
Associated Drug: Pioglitazone
Title: Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02068508/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Pioglitazone
Outcome Measures: Primary: 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: 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)|Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points, Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by \< 30 units, \>= 30 and \< 60 units, \>= 60 and \< 90 units, \>= 90 units at each time points., Baseline, Week 52, and final assessment (up to Week 52)
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 1067
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2009-07-30
Completion Date: 2014-06-30
Results First Posted: 2019-02-18
Last Update Posted: 2019-03-12
Locations:
URL: https://clinicaltrials.gov/show/NCT02068508