A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)
2020년 3월 6일 업데이트: Eli Lilly and Company
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
814
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국, 102206
- Peking University International Hospital
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Beijing, 중국
- Beijing Hai Dian Hospital
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Shanghai, 중국, 200090
- Shanghai Yangpu District Central Hospital
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Beijing
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Beijing, Beijing, 중국, 100044
- Peking University Peoples Hospital
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Beijing, Beijing, 중국, 100016
- Beijing Huaxin Hospital
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Chaoyang, Beijing, 중국, 100028
- China Meitan General Hospital
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Fangshan, Beijing, 중국, 102500
- Beijing Yanhua Hospital
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Gansu
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Lanzhou, Gansu, 중국, 730030
- The 2nd Hospital of Lanzhou University
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Guangdong
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Shenzhen, Guangdong, 중국, 518020
- Shenzhen City People Hospital
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Yuexiu, Guangdong, 중국, 510080
- The 1st Hospital with Guangdong Pharmaceutical University
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Henan
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Luoyang, Henan, 중국, 471003
- The 1st Affiliated Hospital of Henan Science and technology
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Zhengzhou, Henan, 중국, 450003
- People's Hospital of Henan Province
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Hubei
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Wuhan, Hubei, 중국, 430022
- Wuhan Union (Xiehe) Hospital
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Jiangsu
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Changzhou, Jiangsu, 중국, 213003
- Changzhou No.2 People's Hospital
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Nanjing, Jiangsu, 중국, 210001
- Nanjing TCM hospital
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Nanjing, Jiangsu, 중국, 210024
- Jiang Su Province Official Hospital
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Nanjing, Jiangsu, 중국, 210048
- Nanjing Jiangbei Hospital
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Nanjing, Jiangsu, 중국, 211100
- Nanjing Jiangning Hospital
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Taizhou, Jiangsu, 중국, 225300
- Taizhou City People Hospital
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Wuxi, Jiangsu, 중국, 214000
- The Second People's Hospital of Wuxi
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Xuzhou, Jiangsu, 중국, 221009
- Xuzhou Central Hospital
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Shandong
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Qingdao, Shandong, 중국, 266071
- Qingdao Municipal Hospital
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Taian, Shandong, 중국, 271000
- Taian City Central Hospital
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Shanghai
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Shanghai, Shanghai, 중국, 200135
- Shanghai Pudong New Area Gongli Hospital
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Shanghai, Shanghai, 중국, 201318
- Shanghai Pudong New District Zhoupu Hospital
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Shunqing
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Nanchong, Shunqing, 중국, 637000
- Affiliated Hospital of North Sichuan Medical College
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- The Third Affiliated Hospital of Chengdu University of TCM
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Luzhou, Sichuan, 중국, 646000
- Southwest Medical University Affiliated Hospital
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Tianjin
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Nankai, Tianjin, 중국, 300192
- Tianjin First Central Hospital
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Tongzhou
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Beijing, Tongzhou, 중국, 101149
- Beijing Luhe Hospital Capital Medical University
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310014
- Zhejiang Provincial People's Hospital
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Ningbo, Zhejiang, 중국, 315010
- Ningbo First Hospital
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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
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Exclusion Criteria:
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
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)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
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Administered SC
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실험적: Basal Insulin Analog
Basal insulin analog given SC.
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Administered SC
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
기간: Baseline, 24 Weeks
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 24 Weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Week 48 in HbA1c
기간: Baseline, 48 Weeks
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 48 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 24
기간: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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24 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 48
기간: 48 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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48 Weeks
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Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
기간: Baseline, 24 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
기간: Baseline, 48 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 48 Weeks
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Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
기간: Baseline, 24 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
기간: Baseline, 48 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 48 Weeks
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Total Daily Insulin Dose at Week 24 and 48
기간: 24 Weeks, 48 Weeks
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Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
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24 Weeks, 48 Weeks
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Change From Baseline to Week 24 in Body Weight
기간: Baseline, 24 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Body Weight
기간: Baseline, 48 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 48 Weeks
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Rate of Hypoglycemia at Week 24 and 48
기간: 24 Weeks, 48 Weeks
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Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L).
The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25)
as an offset variable.
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24 Weeks, 48 Weeks
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Number of Participants With Insulin Treatment Change at Week 48
기간: Baseline through 48 Weeks
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Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
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Baseline through 48 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
기간: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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24 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
기간: 48 Weeks
|
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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48 Weeks
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Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
기간: Baseline, 48 Weeks
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The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy.
The SEITQ consists of 5 items (that is, statements).
The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications.
Each item score ranges from 1 (strongly disagree) to 7 (strongly agree).
The total SEITQ score is the sum of each item scores, with the range of 5 to 35.
Higher SEITQ score indicates better outcome (higher self-efficacy).
LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
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Baseline, 48 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
연구 시작
2017년 2월 6일
기본 완료 (실제)
기본 완료
2019년 2월 19일
연구 완료 (실제)
연구 완료
2019년 7월 12일
연구 등록 날짜
최초 제출
최초 제출
2017년 1월 11일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2017년 1월 11일
처음 게시됨 (추정)
처음 게시됨
2017년 1월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2020년 3월 18일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 6일
마지막으로 확인됨
마지막으로 확인됨
2019년 8월 15일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 16507
- F3Z-GH-IOQR (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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
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