Clinical trial NCT02003014: Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"
Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / 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: 2013-12-06
Enrollment: 899
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to 12 months
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
measure: Change From Baseline in Immunoreactive Insulin (IRI)
timeFrame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
measure: Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: