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Trial record 1 of 1 for:    237-019
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Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02181842
First received: July 2, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose
The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

Condition Intervention
Type 2 Diabetes Mellitus Drug: Pioglitazone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Changes from baseline in laboratory parameters [ Time Frame: From baseline to 48 weeks of treatment ]
    Changes from baseline in laboratory parameters wil be tabulated and analyzed.

  • Changes from baseline in laboratory parameters characteristics at the time of enrollment [ Time Frame: From baseline to 48 weeks of treatment ]
    Changes from baseline in laboratory parameters will be tabulated and analyzed by baseline characteristics at the time of enrollment.

  • Change in the rate of patients achieving good glycemic control (i.e., reduction in HbA1c values < 6.5%) [ Time Frame: From baseline to 48 weeks of treatment ]
    Change in the rate of patients achieving good glycemic control (i.e., reduction in HbA1C values < 6.5%) will be tabulated and analyzed.

  • Blood glucose-related laboratory parameters at each time point [ Time Frame: From baseline to 48 weeks of treatment ]
    Blood glucose-related laboratory parameters at each time point will be tabulated and analyzed.


Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: For 48 weeks ]

    The frequencies of all adverse events observed during the observation period will be tabulated by symptom, type, and seriousness. In addition, the frequency of recurrence of cerebral infarction will be tabulated by time from first onset of cerebral infarction, risk factors for cerebral infarction, concomitant antihypertensive medications (if any), and concomitant antiplatelet/anticoagulant medications (if any).

    Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of pioglitazone whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with pioglitazone are defined as adverse drug reactions.



Enrollment: 246
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral administration of 15-30 mg of pioglitazone
Oral administration of 15-30 mg of pioglitazone once daily before or after breakfast (the dose can be adjusted; however, the maximum daily dose should not exceed 45 mg)
Drug: Pioglitazone
Pioglitazone tablets
Other Name: Actos Tablets

Detailed Description:

This survey was designed to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

For adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. The dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 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:

  • Type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, [1] to [3], at the time of enrollment in the survey:

    1. First onset of cerebral infarction was at least 24 weeks prior to enrollment
    2. HbA1c values ≥ 6.5% within 12 weeks prior to the start of treatment with Actos Tablets
    3. No prior history of treatment with Actos Tablets since the first onset of cerebral infarction

Exclusion Criteria:

  • Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey:

    1. Contraindication for Actos Tablets
    2. Prior history of recurrence of cerebral infarction
    3. Prior history of cerebral hemorrhage or subarachnoid hemorrhage
    4. Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
    5. Reduced cardiac function (defined as an ejection fraction [EF] ≤ 40%)
  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: NCT02181842

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02181842     History of Changes
Other Study ID Numbers: 237-019
Study First Received: July 2, 2014
Last Updated: July 2, 2014

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Diabetes Mellitus, Type 2
Cerebral Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017