Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Pioglitazone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Postmarketing Group Manager, Study Chair, Affiliation: Takeda
Summary
The purpose of this study is to investigate the safety and efficacy of long-term treatment
with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with
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.
Clinical Details
Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Frequency of adverse drug reactions
Secondary outcome: Changes in glycemia-related parameters (fasting blood glucose, glycosylated hemoglobin [HbA1c])Changes in test values (fasting triglycerides, HDL cholesterol, and LDL cholesterol) Changes in the daily dose of insulin product
Detailed description:
This is a special drug use surveillance on long-term use of newly co-administered
pioglitazone tablets (Actos Tablets) 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 in the routine clinical setting in
combination with 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients 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. Patients treated with an insulin product for at least 4 weeks
2. Patients who started Actos Tablets for the first time after the start of an insulin
product
3. Patients likely to be available for a 52-week observation and evaluation after the
start of co-administration of Actos Tablets
Exclusion Criteria:
Patients with contraindications to Actos Tables and insulin products treatment
Locations and Contacts
Additional Information
Starting date: July 2009
Last updated: August 25, 2014
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