- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01590797
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
2018년 7월 20일 업데이트: Merck Sharp & Dohme LLC
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy, Alone or in Combination With Metformin
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable insulin alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM).
The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on insulin alone or in combination with metformin.
연구 개요
연구 유형
중재적
등록 (실제)
467
단계
- 3단계
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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- has T2DM
- is currently on a stable regimen of pre-mixed, intermediate-acting, or long-acting insulin at a dose of at least 12 U/day, either alone or in combination with metformin >=1500 mg/day for ≥ 10 weeks
- has a Visit 1/Screening HbA1C between 7.5% and 11.0%
- is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication
Exclusion Criteria:
- has been treated with any antihyperglycemic therapies other than a protocol-required insulin (alone or with metformin) within the prior 12 weeks or has ever
been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue
- is currently on treatment with daily use (one or more injections per day) of
pre-prandial short-acting or rapid-acting insulin
- has a history of 2 or more episodes of hypoglycemia resulting in seizure,
coma, or loss of consciousness, or has had recurrent episodes of hypoglycemia over the past 8 weeks
- has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, insulin, or metformin
- is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
- has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
- has a medical history of active liver disease
- has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
- has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
- has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
- has human immunodeficiency virus (HIV)
- has severe peripheral vascular disease
- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- has a clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
- is a user of recreational or illicit drugs or has had a recent history of drug abuse
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Sitagliptin
Participants treated with sitagliptin 100 mg, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Sitagliptin 100 mg once daily for 24 weeks
다른 이름들:
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
|
위약 비교기: Placebo
Participants treated with placebo matching sitagliptin, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
Matching placebo once daily for 24 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
기간: Baseline and Week 24
|
Baseline and Week 24
|
|
Number of Participants With One or More Adverse Events
기간: Up to Week 26
|
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to Week 26
|
Number of Participants Discontinuing Study Medication Due to an AE
기간: Up to Week 24
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to Week 24
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin
기간: Baseline and Week 24
|
Baseline and Week 24
|
Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
기간: Baseline and Week 24
|
Baseline and Week 24
|
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)
2012년 7월 10일
기본 완료 (실제)
2014년 6월 11일
연구 완료 (실제)
2014년 6월 25일
연구 등록 날짜
최초 제출
2012년 5월 1일
QC 기준을 충족하는 최초 제출
2012년 5월 2일
처음 게시됨 (추정)
2012년 5월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 20일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0431-254
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
연구 데이터/문서
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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