A 21-Week, Open-label, Randomized, Controlled, Parallel-group, Multi-center Study Evaluating the Efficacy and Safety of HOE901-U300 Administered According to a Device-Supported Treat-to-target Regimen Versus Routine Titration in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 151
- 试验地点
- 19
- 主要终点
- Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period
研究概览
简要总结
Primary Objective:
To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine Titration Meter) device-supported treat-to-target regimen relative to a routine titration regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2 mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.
Secondary Objective:
To assess the efficacy, safety, and adherence/satisfaction of MyStar DoseCoach
详细描述
The maximum study duration will be 21 weeks per patient that will consist of a 4-week screening period, a 16-week treatment period, and 1-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
MyStar DoseCoach
MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).
干预措施: Insulin glargine (U300) (Drug)
MyStar DoseCoach
MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).
干预措施: MyStar DoseCoach (Device)
Routine Titration
Routine Titration - Routine titration defined by the Investigator. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).
干预措施: Insulin glargine (U300) (Drug)
结局指标
主要结局
Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period
时间窗: Baseline to Week 16
次要结局
- Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire(Baseline to Week 16)
- Percentage of patients reaching HbA1c of <7.5% and <7%(Week 16)
- Percentage of patients with adverse events(Baseline to Week 16)
- Assessment of diabetes-related emotional stress using Diabetes Distress Scale(Baseline to Week 16)
- Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia(Baseline to Week 16)
- Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks)(Baseline to Week 16)
- Number of hypoglycemic events(Baseline to Week 16)
- Percentage of patients reaching fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L), (mean of the last 5 readings recorded over the last 2 weeks) without severe and/or confirmed hypoglycemic events(Baseline to Week 16)
- Percentage of patients with serious adverse events(Baseline to Week 16)
- Assessment of emotional well-being using WHO-5 well-being index(Baseline to Week 16)
- Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)(Baseline to Week 16)
- Mean FPG glucose change from baseline(Baseline to Week 16)
- Mean HbA1c change from baseline(Baseline to Week 16)
- Percentage of patients with hypoglycemic events(Baseline to Week 16)
- Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II(Baseline to Week 16)
- Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey(Baseline to Week 16)
- Assessment of device Ease of Use using Ease of Use questionnaire(Baseline to Week 16)