NCT02227212已完成3 期
A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Ease-of-use / ease of learning questionnaire
研究概览
简要总结
Primary Objective:
To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.
Secondary Objectives:
To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.
The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.
详细描述
The total study duration for a participants can be approximately up to 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Insulin glargine U300
Experimental
Once daily subcutaneous injection for 4 weeks
干预措施: Insulin glargine U300 (new formulation of insulin glargine) HOE901 (Drug)
结局指标
主要结局
Ease-of-use / ease of learning questionnaire
时间窗: Day 1, Day 7 , 4-weeks
次要结局
- Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4(Baseline, week 4)
- Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4(Baseline, week 4)
- Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4(Baseline, week 4)
- Number of participants with Product Technical Complaints (PTC)(Baseline to week 4)
- Number of participants with adverse events and hypoglycemic events related to PTC(Baseline to week 4)
- Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)(Baseline, week 4)
- Number of participants with adverse events(screening to week 6)
- Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association(screening to week 6)
- Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)(screening, baseline, week 4)
- Number of participants with site injection site reactions / hypersensitivity reactions(baseline to week 6)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
3 期
The Multicenter, Open-label, Single-use Autoinjector Convenience StudyMultiple SclerosisNCT00958009EMD Serono109
已完成
2 期
A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVONeovascular Age-related Macular DegenerationMacular EdemaRetinal Vein OcclusionNCT06176963Samsung Bioepis Co., Ltd.34
已完成
3 期
Usability of an AI for M923 in Subjects With Moderate to Severe RARheumatoid ArthritisNCT02722044Momenta Pharmaceuticals, Inc.33
已完成
不适用
Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.Type 2 DiabetesType 1 DiabetesNCT01745549Consorzio Mario Negri Sud87
已完成
1 期
To Assess the Patients' Ability to Self-Administer FasinumabOsteoarthritis, HipOsteoarthritis, KneeNCT03491904Regeneron Pharmaceuticals100