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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 juillet 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

246

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Type 2 diabetes mellitus

La description

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%)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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).
Médicament: Pioglitazone
Comprimés de pioglitazone
Autres noms:
  • Actos Comprimés

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
Délai: 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 %)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Takeda

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 janvier 2009

Achèvement primaire (Réel)

30 juin 2011

Achèvement de l'étude (Réel)

30 juin 2011

Dates d'inscription aux études

Première soumission

2 juillet 2014

Première soumission répondant aux critères de contrôle qualité

2 juillet 2014

Première publication (Estimation)

4 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juillet 2018

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 237-019
  • JapicCTI-142568 (Identificateur de registre: JapicCTI)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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