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Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

22 août 2018 mis à jour par: Takeda

Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

The purpose of this survey is to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on long-term pioglitazone (Actos Tablets) treatment.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20000.

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Type d'étude

Observationnel

Inscription (Réel)

18223

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

20 ans à 74 ans (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:

  • Patients must have type 2 diabetes mellitus and have undergone measurements for all of the following parameters to be included in this survey:

Waist circumference, height, body weight, blood pressure, Haemoglobin A1c (HbA1c), fasting triglyceride, High-density Lipoprotein (HDL)-cholesterol

Exclusion Criteria:

  • Patients meeting any of the following criteria (1) to (5) will be excluded:

    1. Patients with any contraindications to pioglitazone (Actos Tablets) treatment as specified below:

      Cardiac failure, history of cardiac failure, severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, serious hepatic dysfunction, serious renal dysfunction, severe infection, perioperative state, serious trauma, history of hypersensitivity to any ingredients of pioglitazone (Actos Tablets), pregnancy or possible pregnancy

    2. Patients aged < 20 or ≥ 75 years
    3. Patients who currently have or have had any of the following: myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease (including left ventricular hypertrophy with cardiac hypofunction*), atrial fibrillation, atrial flutter, valvular disease, aortic dissection, cerebral infarction, cerebral hemorrhage (including subarachnoid hemorrhage). (*Reduced cardiac function is roughly defined as having a brain natriuretic peptide [BNP] ≥ 40 pg/mL.)
    4. Patients who have taken pioglitazone (Actos Tablets) within 3 months before enrollment in this survey
    5. Patients who have been enrolled in the candesartan cilexetil (Blopress) special drug use surveillance "hypertension: survey on metabolic equivalents (MetS) (Challenge-MetS)" at each medical institution.

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 15 to 30 mg
administered orally once daily before or after breakfast for 3 years.
Médicament: Pioglitazone
Comprimés de pioglitazone
Autres noms:
  • ACTO

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events
Délai: From Baseline, Up to 3 Years
Cerebral and cardiovascular events (Macroangiopathy) include the following: Sudden death, Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, Acute myocardial infarction, Angina pectoris requiring intervention or hospitalization for treatment, Cardiac failure requiring hospitalization for treatment, Atrial fibrillation, Aortic dissection. Reported data was frequency of participants who met at least one new cerebral and cardiovascular event throughout this study.
From Baseline, Up to 3 Years
Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in body weight as a one of metabolic syndrome parameters and for each gender (male/female).
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in waist circumference as a one of metabolic syndrome parameters and for each gender (male/female).
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HbA1c (NGSP) as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood glucose as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood insulin level as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in total cholesterol level as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HDL cholesterol level as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting triglyceride level as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in systolic blood pressure as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)
Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in diastolic blood pressure as a one of metabolic syndrome parameters.
From Baseline and final assessment point (Up to 3 Years)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point
Délai: From Baseline and final assessment point (Up to 3 Years)
Changes from baseline in HbA1c (NGSP) with number of MetS-related factor were reported instead. Risk factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, and Family History of Diabetes in Second-Degree Relatives.
From Baseline and final assessment point (Up to 3 Years)
Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events
Délai: 3 Years
3 Years

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)

16 octobre 2007

Achèvement primaire (Réel)

30 juin 2013

Achèvement de l'étude (Réel)

30 juin 2013

Dates d'inscription aux études

Première soumission

1 décembre 2013

Première soumission répondant aux critères de contrôle qualité

1 décembre 2013

Première publication (Estimation)

6 décembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 237-016
  • JapicCTI-132328 (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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