- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01970046
A Phase III Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes
A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase III Study to Access the Efficacy and Safety of SP2086 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Beijing, 중국
- 모병
- Chinese PLA General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients diagnosed with type 2 diabetes mellitus
- subject on metformin monotherapy with stable dose ≥1500mg/d for ≥8 weeks
- 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in
- Body Mass Index: ≥19 and ≤35 kg/m2
Exclusion Criteria:
- <80% or >120% compliance with placebo treatment during the run-in period
- Patients used the following drugs or therapies prior to randomization:
1) Somatropin therapy within 6 months prior to randomization 2) History of drug or alcohol abuse within 6 months prior to randomization 3) Participate in clinical trials of any drugs or medical devices within 3 months prior to randomization 4) Receive corticosteroids long-term (more than 7 consecutive days) oral, non-gastrointestinal administration or intra-articular administration within 2 months prior to randomization 5) Weight control drugs administration or Surgeries resulting in weight instability within 2 months prior to randomization 6) In investigator's opinion, patients used any drugs that interfere with assessment of the investigational product, or produce vital organs toxicity 4. Patients with history of the following diseases or proof prior to randomization:
- Type 1 diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage and secondary diabetes, such as caused by Cushing's syndrome or acromegaly
- a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
- a history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
- serious haematological diseases or other diseases leading to hemolyze and Red Blood Cell unstable (malaria、haemolytic anaemia eg. )
- other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
- Any organ system tumors except the local skin basal cell carcinoma that have been treated or not been treated within 5 years prior to randomization, regardless of whether there is evidence of local recurrence or metastasis ; a history or family history of medullary carcinoma of thyroid ; a history of multiple endocrine neoplasia
- Decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical significance arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention within 6 months prior to randomization
- Acute metabolic complications (ketoacidosis, lactic acidosis or hyperosmolar coma), unstable proliferative retinopathy or macular degeneration within 6 months prior to randomization
- Severe trauma or acute infection that may affect blood glucose control within 4 weeks prior to randomization
- Severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
- With a history of mental/emotional disorder that would interfere with the subject's participation in the study.
5. Patients with any laboratory parameters meet the following criteria prior to randomization:
- Aspartate Aminotransferase or alanine aminotransferase ≥ 2.0× upper normal limit(UNL) , and/or total bilirubin ≥ 2.0 × UNL also review confirmed within 3 days;
- Triglyceride>5.64mmol/L(500mg/dl);
- serum creatinine to exceed the normal range
- thyroid stimulating hormone to exceed the normal range, and have clinical significance
- blood amylase o exceed the normal range, and have clinical significance
- In investigator's opinion, any significant laboratory abnormalities of clinical significance value that interfere with assessment of this study.
6. At Screening patients not installed pacemaker with II or III degree atrioventricular block, long QT syndrome or QT corrected > 500 ms 7. Patients who received blood transfusions or blood donation≥ 400 mL or severe blood loss at least 400 mL within 8 weeks prior to randomization
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약/메트포르민
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실험적: SP2086 (50mg b.i.d)/Metformin
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실험적: SP2086 (50mg q.d.)/Metformin
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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24주차에 HbA1c(헤모글로빈 A1C)의 기준선에서 변화
기간: 기준선, 24주차
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A1C는 백분율로 측정됩니다.
따라서 기준선으로부터의 이러한 변화는 24주 A1C 퍼센트에서 0주 A1C 퍼센트를 뺀 값을 반영합니다.
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기준선, 24주차
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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24주차에 기준선에서 식후 2시간 포도당(2시간 PMG)의 변화
기간: 0-24주
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24주 기준선으로부터의 변화는 24주 2시간 PMG에서 0주 2시간 PMG를 뺀 값으로 정의됩니다.
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0-24주
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4주, 8주, 12주, 24주, 38주, 52주에 지질의 기준선에서 변화
기간: 4주차, 8주, 12주, 24주, 38주, 52주
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4주차, 8주, 12주, 24주, 38주, 52주
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4주, 8주, 12주, 24주, 38주, 52주에 기준선에서 체중의 변화
기간: 4주차, 8주, 12주, 24주, 38주, 52주
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4주차, 8주, 12주, 24주, 38주, 52주
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Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
기간: week24, 52
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week24, 52
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Change From Baseline in fasting plasma glucose (FPG) at Week 24,52
기간: Weeks 0-24-52
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Change from baseline at Week 24,52 is defined as Week 24 ,52 FPG minus Week 0 FPG
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Weeks 0-24-52
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Change From Baseline in HbA1c at Week 52
기간: week 52
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A1C is measured as a percent.
Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent
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week 52
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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