Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Percentage of participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Primary Objective:
To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs
Secondary Objective:
To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)
详细描述
The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.
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
Insuline Glargine (U300) (Gla-300)
Insulin glargine (U300) once daily for 24 weeks on top of non-insulin antidiabetic drug. Insulin dose will be adjusted according to the recommended titration algorithm
干预措施: Insulin glargine (U300) (Drug)
结局指标
主要结局
Percentage of participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline to Week 24
TEAEs including serious adverse events (SAEs) and hypoglycemic episode
次要结局
- Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)(Week 12 and Week 24)
- Percentage of participants requiring rescue therapy(Week 12 and Week 24)
- Change in fasting plasma glucose (FPG) from Baseline to Week 24(Baseline to Week 24)
- Change in fasting SMBG from Baseline to Week 24(Baseline to Week 24)
- Change in insulin dose from Baseline to Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Percentage of participants with at least one confirmed hypoglycemia event(Baseline to Week 24)
- Change in HbA1c from Baseline to week 12 and week 24(Baseline to Week 12 and Week 24)
- Percentage of participants reaching HbA1c target of <7%(Week 12 and Week 24)
- Change in 7-point SMBG profile from Baseline to Week 24(Baseline to Week 24)
- Change in DTSQs scores from Baseline to Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Change in body weight from Baseline to Week 12 and Week 24(Baseline to Week 12 and Week 24)