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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

Page last updated: August 20, 2015

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