Clinical trial NCT02068508: Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 1067
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus

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.

Detailed description: This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.

Eligibility criteria: Inclusion Criteria:

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.

1. Participants treated with an insulin product for at least 4 weeks
2. Participants who started Actos Tablets for the first time after the start of an insulin product
3. Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets

Exclusion Criteria:

Participants with contraindications to Actos Tables and insulin products treatment

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to Week 52
Secondary outcomes:
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
measure: Change From Baseline in Fasting Triglycerides
timeFrame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
measure: Change From Baseline in HDL Cholesterol
timeFrame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
measure: Change From Baseline in LDL Cholesterol
timeFrame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
measure: Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points
timeFrame: Baseline, Week 52, and final assessment (up to Week 52)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: