NCT02967237已完成4 期
An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin
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
- 136
- 试验地点
- 85
- 主要终点
- Mean change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.
Secondary Objectives:
- Evolution of fasting plasma glucose
- Evolution of insulin dose and body weight
- Hypoglycemia incidence
- Safety
- Patients satisfaction when they change their insulin for HOE901-U300
详细描述
The total study duration per patient is approximately 28 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
Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen
干预措施: insulin glargine (U300) (Drug)
结局指标
主要结局
Mean change from baseline in HbA1c
时间窗: Baseline, Week 24
次要结局
- Number of adverse events(From inclusion up to Week 24)
- Percentage of patients with HbA1c <7%, <7.5%, and <8%(At Week 24)
- Mean change from baseline in fasting plasma glucose(Baseline to Week 12 and Week 24)
- Change in Diabetes Treatment Satisfaction Questionnaire score(Week 24)
- Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)(Baseline to Week 24)
- Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)(Baseline to Week 12 and Week 24)
- Number of hypoglycemic events(From inclusion up to Week 24)
- Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)(At Weeks 12 and 24)
研究者
研究点 (85)
Loading locations...
相似试验
已完成
4 期
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) FailureType 2 Diabetes MellitusNCT01461577Sanofi89
已完成
4 期
Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative StudyDiabetes Mellitus, Type 2NCT01121835Sanofi934
已完成
3 期
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.Type 1 Diabetes MellitusNCT01223131Sanofi162
已完成
3 期
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes MellitusType 1 Diabetes MellitusNCT02735044Sanofi463
已完成
4 期
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents FailureDiabetes Mellitus, Type 2NCT01117350Sanofi978