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Trial record 1 of 1 for:    237-017
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Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02003014
First received: December 1, 2013
Last updated: September 21, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Drug: Pioglitazone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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).

  • 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.

  • 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.


Enrollment: 899
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pioglitazone 15 mg to 30 mg
administered orally once daily
Drug: Pioglitazone
Pioglitazone Tablets
Other Name: Actos

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes mellitus
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003014

Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02003014     History of Changes
Other Study ID Numbers: 237-017
JapicCTI-132329 ( Registry Identifier: JapicCTI )
JapicCTI-R160828 ( Registry Identifier: JapicCTI )
Study First Received: December 1, 2013
Results First Received: December 7, 2015
Last Updated: September 21, 2016

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017