Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
2018년 3월 7일 업데이트: Eli Lilly and Company
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.
Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
379
단계
- 3단계
연락처 및 위치
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연구 장소
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Guadalajara, 멕시코, 44670
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Monterrey, 멕시코, 64060
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California
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Santa Ana, California, 미국, 92705
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District of Columbia
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Washington, District of Columbia, 미국, 20010
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Florida
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Hollywood, Florida, 미국, 33021
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New Port Richey, Florida, 미국, 34652
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South Miami, Florida, 미국, 33143
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Hawaii
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Honolulu, Hawaii, 미국, 96813
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Idaho
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Idaho Falls, Idaho, 미국, 83404
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Louisiana
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New Orleans, Louisiana, 미국, 70121
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Maine
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Biddeford, Maine, 미국, 04005
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Minnesota
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Minneapolis, Minnesota, 미국, 55416
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New Jersey
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Stratford, New Jersey, 미국, 08084
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South Carolina
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Greenville, South Carolina, 미국, 29605
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Texas
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Austin, Texas, 미국, 78731
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San Antonio, Texas, 미국, 78229
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Utah
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Salt Lake City, Utah, 미국, 84124
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Washington
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Renton, Washington, 미국, 98057
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Tacoma, Washington, 미국, 98405
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Brugge, 벨기에, 8000
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Brussels, 벨기에, 1070
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Leuven, 벨기에, 3000
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Liege, 벨기에, 4000
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Alcira, 스페인, 46600
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Alicante, 스페인, 03114
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Granada, 스페인, 18014
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La Coruña, 스페인, 15006
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Palma De Mallorca, 스페인, 07198
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Requena, 스페인, 46340
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Buenos Aires, 아르헨티나, 1012
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Vienna, 오스트리아, 1090
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Wien, 오스트리아, A-1030
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Ahmedabad, 인도, 380006
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Bangalore, 인도, 560052
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Chennai, 인도, 600116
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Caguas, 푸에르토 리코, 00726
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Ponce, 푸에르토 리코, 00717-2075
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Rio Piedras, 푸에르토 리코, 00921
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La Roche Sur Yon, 프랑스, 85925
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La Rochelle, 프랑스, 17019
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Rouen, 프랑스, 76031
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Valenciennes, 프랑스, 59322
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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 mellitus for at least 6 months
- Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
- Patients who have been treated with the following regimen:
One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
AND
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
AND
are candidates for insulin therapy, in the opinion of the investigator.
Exclusion Criteria:
- Pregnancy
- Smoker
- History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
- Diagnosed with pneumonia in the 3 months prior to screening
- Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
- History of renal transplantation
- History of lung transplantation
- Active or untreated malignancy
- Treated with Incretin mimetics
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 |
|---|---|
|
실험적: 1
|
patient specific dose, inhaled, before meals,6 months
다른 이름들:
|
|
실험적: 2
|
의약품: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 6 months
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
치료 만족도
기간: 6 개월
|
6 개월
|
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Mean change in HbA1c from baseline to various endpoints.
기간: 6 months
|
6 months
|
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Patient safety
기간: throughout the study
|
throughout the study
|
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Patient reported outcome from W-BQ12
기간: screening,baseline,month 6
|
screening,baseline,month 6
|
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Insulin dose
기간: throughout the study
|
throughout the study
|
|
Patient reported outcome from DSC-R
기간: screening,baseline, month 6
|
screening,baseline, month 6
|
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Patient reported outcome from DTSQS
기간: screening,baseline, month 6
|
screening,baseline, month 6
|
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Patient reported outcome from IDSQ
기간: Month 1, 2 and 6
|
Month 1, 2 and 6
|
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Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
기간: baseline, screening, month 6
|
baseline, screening, month 6
|
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 10월 1일
기본 완료 (실제)
2008년 5월 1일
연구 완료 (실제)
2008년 5월 1일
연구 등록 날짜
최초 제출
2006년 10월 19일
QC 기준을 충족하는 최초 제출
2006년 10월 19일
처음 게시됨 (추정)
2006년 10월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 3월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 3월 7일
마지막으로 확인됨
2018년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9630
- H7U-MC-IDAY (기타 식별자: Eli Lilly and Company)
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