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Completed

NCT Number: NCT02003014

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
  • Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
  • Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Exclusion criteria

  • Patients who have received Actos Tablets within the past 3 months.
  • Patients who started treatment with biguanides and Actos Tablets simultaneously
  • Patients who discontinued biguanides and switched to Actos Tablets treatment.
  • Patients who received additional biguanides after the start of Actos Tablets treatment
  • Patients with contraindications to Actos Tablets treatment

Treatment and study plan

pioglitazone

Drug

Pioglitazone Tablets

Other names: Actos

Primary outcomes

  1. Number of Participants Reporting One or More Adverse Drug Reactions

    Time frame: 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.

  2. Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Time frame: 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 outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: 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.

  2. Change From Baseline in Fasting Blood Glucose

    Time frame: 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.

  3. Change From Baseline in Body Weight

    Time frame: 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).

  4. Change From Baseline in Immunoreactive Insulin (IRI)

    Time frame: 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.

  5. Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 6, 2013
Registry last updated
Nov 10, 2016

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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