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Completed

NCT Number: NCT02068508

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

The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care 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 the routine clinical setting in 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants 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.

  • Participants treated with an insulin product for at least 4 weeks
  • Participants who started Actos Tablets for the first time after the start of an insulin product
  • Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets

Exclusion criteria

Participants with contraindications to Actos Tables and insulin products treatment

Treatment and study plan

pioglitazone

Drug

Pioglitazone Tablets

Other names: Actos

Primary outcomes

  1. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

    Time frame: Up to Week 52

    ADRs 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.

Secondary outcomes

  1. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)

  2. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)

  3. Change From Baseline in Fasting Triglycerides

    Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)

  4. Change From Baseline in HDL Cholesterol

    Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)

  5. Change From Baseline in LDL Cholesterol

    Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)

  6. Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points

    Time frame: Baseline, Week 52, and final assessment (up to Week 52)

    Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2014
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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