Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
2019년 9월 6일 업데이트: Eli Lilly and Company
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes.
Patients will be treated for 24 months with a 2-month follow-up period.
연구 개요
연구 유형
중재적
등록 (실제)
415
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Changhua, 대만, 500
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Neihu Taipei, 대만, 114
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Yungkang City, 대만, 710
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Berlin, 독일, 10115
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Dresden, 독일, 01307
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Erlangen, 독일, 91054
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Frankfurt, 독일, 60596
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Leipzig, 독일, D-04103
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Mainz, 독일, D-55116
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Mexico City, 멕시코, 06700
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Monterrey, 멕시코, 64410
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California
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Sacramento, California, 미국, 95825
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Santa Ana, California, 미국, 92705
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Florida
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Jacksonville, Florida, 미국, 32204
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Miami, Florida, 미국, 33156
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
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New Jersey
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Hamilton, New Jersey, 미국, 08610
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South Carolina
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Greenville, South Carolina, 미국, 29605
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Utah
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Ogden, Utah, 미국, 84403
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West Virginia
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Charleston, West Virginia, 미국, 25304
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Fortaleza, 브라질, 60120-020
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Porto Alegre, 브라질, 90035-003
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São Paulo, 브라질, 04020041
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Catania, 이탈리아, 95100
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Genova, 이탈리아, 16132
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Milano, 이탈리아, 20132
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Pisa, 이탈리아, 56100
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Rome, 이탈리아, 00168
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Bangalore, 인도, 560010
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Mumbai, 인도, 400 007
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Pune, 인도, 411005
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Coimbra, 포르투갈, 3000-076
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Lisbon, 포르투갈, 1250-203
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Katowice, 폴란드, 40-044
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Lublin, 폴란드, 20-954
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Olesnica, 폴란드
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Manatí, 푸에르토 리코, 00674
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San Juan, 푸에르토 리코, 00907
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Yabucoa, 푸에르토 리코, 00767
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Budapest, 헝가리, H-1139
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Mako, 헝가리, 6900
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Veszprem, 헝가리, 8200
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Zalaegerszeg, 헝가리, 8900
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Type 2 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Pulmonary, hepatic, or renal disease
- Congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
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patient specific dose, inhaled, before meals, 24 months
다른 이름들:
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활성 비교기: 2
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patient specific dose, injectable, before meals, 24 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
기간: 24 months
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24 months
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To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
기간: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
기간: baseline, 6 months, 12 months, 18 months, 24 months
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baseline, 6 months, 12 months, 18 months, 24 months
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To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
기간: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
기간: throughout the study
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throughout the study
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
기간: 24 months
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24 months
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To test dose titration methods
기간: 6 months
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6 months
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To assess inhaler reliability
기간: throughout the study
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throughout the study
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
기간: 3 months, 6 months
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3 months, 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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
2006년 4월 1일
기본 완료 (실제)
2008년 5월 1일
연구 완료 (실제)
2008년 5월 1일
연구 등록 날짜
최초 제출
2006년 5월 10일
QC 기준을 충족하는 최초 제출
2006년 5월 10일
처음 게시됨 (추정)
2006년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 6일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9626
- H7U-MC-IDAU (기타 식별자: Eli Lilly and Company)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 공유 기간
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 공유 액세스 기준
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
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
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Postgraduate Institute of Medical Education and...완전한
Human Insulin Inhalation Powder에 대한 임상 시험
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First Affiliated Hospital, Sun Yat-Sen University알려지지 않은