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Trial record 1 of 1 for:    237-018
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Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02068508
First received: February 19, 2014
Last updated: August 25, 2014
Last verified: August 2014
  Purpose
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with 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.

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 Insulin Products / Long-term Treatment"

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse drug reactions [ Time Frame: 52 weeks from the baseline ]
    Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions..


Secondary Outcome Measures:
  • Changes in glycemia-related parameters (fasting blood glucose, glycosylated hemoglobin [HbA1c]) [ Time Frame: 52 weeks from the baseline ]
    Tabulation and analysis of fasting blood glucose and HbA1c.

  • Changes in test values (fasting triglycerides, HDL cholesterol, and LDL cholesterol) [ Time Frame: 52 weeks from the baseline ]
    Tabulation and analysis of fasting triglycerides, HDL cholesterol, and LDL cholesterol)

  • Changes in the daily dose of insulin product [ Time Frame: 52 weeks from the baseline ]
    Tabulation and analysis of the daily dose of insulin product.


Enrollment: 1067
Study Start Date: July 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pioglitazone 15 mg to 30 mg, orally, once daily Drug: Pioglitazone
Pioglitazone Tablets
Other Name: Actos

Detailed Description:
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) 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 in the routine clinical setting in combination with 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.
  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:

Patients 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.

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

Exclusion Criteria:

Patients with contraindications to Actos Tables and insulin products 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: NCT02068508

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02068508     History of Changes
Other Study ID Numbers: 237-018
JapicCTI-132376 ( Registry Identifier: JapicCTI )
Study First Received: February 19, 2014
Last Updated: August 25, 2014

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
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017