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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Pioglitazone

• Registration Number: NCT02003014
• Lead Sponsor: Takeda

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-01
• Study First Posted: 2013-12-06
• Results First Submitted: 2015-12-07
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Results First Posted: 2016-11-10
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 899

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pioglitazone 15 mg to 30 mg	Pioglitazone	administered orally once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Adverse Drug Reactions	Baseline up to 12 months	Adverse drug reactions 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.
Number of Participants Reporting One or More Serious Adverse Drug Reactions	Baseline up to 12 months	Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Change From Baseline in Fasting Blood Glucose	Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)	The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Change From Baseline in Immunoreactive Insulin (IRI)	Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)	The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free \[unbound\] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Change From Baseline in Body Weight	Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)	Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).
Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)	The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.