Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
2018년 8월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
18223
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Type 2 diabetes mellitus
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Pioglitazone 15 to 30 mg
administered orally once daily before or after breakfast for 3 years.
|
피오글리타존 정제
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point
기간: 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
기간: 3 Years
|
3 Years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2007년 10월 16일
기본 완료 (실제)
2013년 6월 30일
연구 완료 (실제)
2013년 6월 30일
연구 등록 날짜
최초 제출
2013년 12월 1일
QC 기준을 충족하는 최초 제출
2013년 12월 1일
처음 게시됨 (추정)
2013년 12월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 22일
마지막으로 확인됨
2018년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
제2형 당뇨병에 대한 임상 시험
-
Postgraduate Institute of Medical Education and...완전한
피오글리타존에 대한 임상 시험
-
National Cancer Institute (NCI)종료됨IVA기 구강 편평 세포 암종 AJCC v6 및 v7 | IVA기 구인두 편평 세포 암종 AJCC v7 | IVB기 구강 편평 세포 암종 AJCC v6 및 v7 | IVB 기 구인두 편평 세포 암종 AJCC v7 | III기 구강 편평 세포 암종 AJCC v6 및 v7 | 3기 구인두 편평 세포 암종 AJCC v7 | II기 구강 편평 세포 암종 AJCC v6 및 v7 | 1기 구인두 편평 세포 암종 AJCC v6 및 v7 | II기 구인두 편평 세포 암종 AJCC v6 및 v7 | 구강 신생물 | 구인두 신생물 | 0기 구강 편평 세포 암종 AJCC v6 및 v7 | 0기... 그리고 다른 조건미국
-
Bing He모집하지 않고 적극적으로
-
Torrent Pharmaceuticals Limited완전한
-
Torrent Pharmaceuticals Limited완전한
-
Seung Up Kim모집하지 않고 적극적으로
-
Mario Negri Institute for Pharmacological ResearchFondazione IRCCS Istituto Nazionale dei Tumori, Milano; Humanitas Hospital, Italy모병지방육종, 점액종 | 지방육종, 탈분화 | 지방육종, 원형세포이탈리아