Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
22 agosto 2018 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
18223
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 74 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Type 2 diabetes mellitus
Descrizione
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:
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
- Patients aged < 20 or ≥ 75 years
- 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.)
- Patients who have taken pioglitazone (Actos Tablets) within 3 months before enrollment in this survey
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Pioglitazone 15 to 30 mg
administered orally once daily before or after breakfast for 3 years.
|
Pioglitazone compresse
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point
Lasso di tempo: 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
Lasso di tempo: 3 Years
|
3 Years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 ottobre 2007
Completamento primario (Effettivo)
30 giugno 2013
Completamento dello studio (Effettivo)
30 giugno 2013
Date di iscrizione allo studio
Primo inviato
1 dicembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
1 dicembre 2013
Primo Inserito (Stima)
6 dicembre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 gennaio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 237-016
- JapicCTI-132328 (Identificatore di registro: JapicCTI)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .