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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>

26. Juli 2018 aktualisiert von: Takeda

Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

246

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Type 2 diabetes mellitus

Beschreibung

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 Pioglitazone Tablets
    3. No prior history of treatment with Pioglitazone 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%)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Pioglitazone
Pioglitazone 15-30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast (the dose can be adjusted; however, the maximum daily dose should not exceed 45 mg).
Arzneimittel: Pioglitazon
Pioglitazon-Tabletten
Andere Namen:
  • Actos-Tabletten

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
Zeitfenster: 48 Week
The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level < 130 mg/dL.
48 Week
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
Zeitfenster: 48 Week
The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with HbA1c (NGSP) Values < 6.9 %.
48 Week
Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week
Zeitfenster: From Baseline, Up to 48 Week
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is SBP as a one of laboratory parameters.
From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week
Zeitfenster: From Baseline, Up to 48 Week
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is DBP as a one of laboratory parameters.
From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week
Zeitfenster: From Baseline, Up to 48 Week
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.
From Baseline, Up to 48 Week
Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week
Zeitfenster: From Baseline, Up to 48 Week
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.
From Baseline, Up to 48 Week
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
Zeitfenster: From Baseline, Up to 48 Week
The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment. Mean daily dose of pioglitazone at the time of enrollment were categorized into <15 mg, 15 to <30 mg, 30 <45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).
From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
Zeitfenster: From Baseline, Up to 48 Week
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment. Levels of HbA1c at the time of enrollment were categorized into <6.2%, 6.2 to <6.9%, 6.9 <7.4%, 7.4 <8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in <6.2% and 6.2 to <6.9% group).
From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
Zeitfenster: From Baseline, Up to 48 Week
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment. Gender was categorized into male and female.
From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
Zeitfenster: From Baseline, Up to 48 Week
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment. Levels of BMI at the time of enrollment were categorized into <18.5 kg/m^2, 18.5 to <25 kg/m^2, 25 <30 kg/m^2, and 30 kg/m^2 ≤.
From Baseline, Up to 48 Week
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
Zeitfenster: From Baseline, Up to 48 Week
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment. Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.
From Baseline, Up to 48 Week
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
Zeitfenster: Baseline and 48 Week
Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Baseline and 48 Week
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
Zeitfenster: Baseline and 48 Week
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Baseline and 48 Week

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Zeitfenster: Up to 48 Weeks
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.
Up to 48 Weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Takeda

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Januar 2009

Primärer Abschluss (Tatsächlich)

30. Juni 2011

Studienabschluss (Tatsächlich)

30. Juni 2011

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2014

Zuerst gepostet (Schätzen)

4. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juli 2018

Zuletzt verifiziert

1. Juli 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 237-019
  • JapicCTI-142568 (Registrierungskennung: JapicCTI)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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