Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003014
• Other study ID #: 237-017
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: December 1, 2013
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: December 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

Description:

This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).

The usual adult dosage is 15 to 30 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 45 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 899
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy

2. Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment

3. Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Exclusion Criteria:

1. Patients who have received Actos Tablets within the past 3 months.

2. Patients who started treatment with biguanides and Actos Tablets simultaneously

3. Patients who discontinued biguanides and switched to Actos Tablets treatment.

4. Patients who received additional biguanides after the start of Actos Tablets treatment

5. Patients with contraindications to Actos Tablets treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone
Pioglitazone Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events	The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.	12 months	Yes
Secondary	Changes in diabetes-related test values	Calculation of summary statistics for HbA1c, fasting blood glucose, fasting immunoreactive insulin (IRI), and body weight. Calculation of homeostasis model assessment ratio (HOMA-R) and tabulation of summary statistics.	From the start to 12 months of treatment	No