NCT00576862已完成4 期
Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)
研究概览
简要总结
The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE
- •Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism.
- •Subjects who are likely to comply with the investigator's instructions.
排除标准
- •Evidence of an uncooperative attitude.
- •Subject not on adequate contraception, or who is pregnant, or breast feeding.
- •Subject unable to understand informed consent.
- •Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations.
- •Subject becomes pregnant or is planning to become pregnant.
研究组 & 干预措施
1
Experimental
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)
时间窗: Mean time interval: 10 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell LymphomaLymphoma, Mantle-CellNCT05564052Janssen Research & Development, LLC36
终止
1 期
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511Gliomas, MalignantGlioblastoma MultiformeAstrocytomaNCT04327011Tocagen Inc.65
终止
2 期
A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to PoziotinibNSCLCBreast CancerNCT03744715Spectrum Pharmaceuticals, Inc7
进行中（未招募）
1 期
Estudio abierto de extensión para los pacientes con lumbalgia crónica severa o dolor crónico severo debido a artrosis de rodilla que han completado alguno de los ensayos clínicos previos de fase IIIb de clorhidrato de tapentadol códigos KF5503/42, KF5503/43, KF5503/44 o KF5503/45.Artrosis de rodilla y lumbalgiaMedDRA version: 12.0Level: LLTClassification code 10024891Term: Low back painMedDRA version: 12.0Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2009-015527-82-ESGrünenthal Pharma S.A.128
Unknown
不适用
Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)Crohn's DiseaseNCT02926300Kang Stem Biotech Co., Ltd.24