- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01234597
Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day (SeLan)
A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
연구 개요
상세 설명
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Beer Sheva, 이스라엘
- Investigational Site Number 376003
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Haifa, 이스라엘
- Investigational Site Number 376007
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Kfar Saba, 이스라엘, 44281
- Investigational Site Number 376004
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Lod, 이스라엘
- Investigational Site Number 376012
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Nazareth, 이스라엘
- Investigational Site Number 376013
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Netanya, 이스라엘
- Investigational Site Number 376006
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Ramat-Gan, 이스라엘
- Investigational Site Number 376001
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Sachnin, 이스라엘
- Investigational Site Number 376009
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Tel Aviv, 이스라엘
- Investigational Site Number 376008
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Tel-Aviv, 이스라엘
- Investigational Site Number 376010
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Tel-aviv, 이스라엘
- Investigational Site Number 376011
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
Run-in period:
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
- Patients who according to their physician are eligible to the study
Randomization:
- HbA1c > 7.5%
- FPG < 130 mg/dl
Exclusion criteria:
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
- Patients with mobility difficulties and/or difficulties communicating with the investigator
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
공부 계획
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 |
---|---|
활성 비교기: Arm A: Without Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
|
실험적: Arm B: Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Changes in Hemoglobin A1c (HbA1c) level
기간: Baseline, week 24
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Baseline, week 24
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Rate of hypoglycemia
기간: Week 24
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Week 24
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Changes in insulin glargine dose
기간: Baseline, week 24
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Baseline, week 24
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Changes in insulin glulisine dose
기간: Baseline, week 24
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Baseline, week 24
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .
제2형 당뇨병에 대한 임상 시험
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Postgraduate Institute of Medical Education and...완전한
INSULIN GLARGINE (HOE901)에 대한 임상 시험
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Mannkind Corporation완전한
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Sanofi완전한제2형 당뇨병미국, 호주, 스페인, 대한민국, 헝가리, 멕시코, 이탈리아, 폴란드, 아르헨티나, 캐나다, 콜롬비아, 프랑스, 독일, 일본, 페루, 루마니아, 스웨덴, 영국
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Sanofi완전한