A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on Basal Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 372
- 试验地点
- 14
- 主要终点
- Change in glycated hemoglobin (HbA1c)
研究概览
简要总结
Primary Objective:
To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300.
Secondary Objectives:
To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes.
To evaluate the safety of Gla-300.
详细描述
Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.
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)
Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin
干预措施: INSULIN GLARGINE (U300) (Drug)
结局指标
主要结局
Change in glycated hemoglobin (HbA1c)
时间窗: Baseline to Week 26
Absolute change in HbA1c
次要结局
- Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)(Week 12 and 26)
- Number of participants with adverse events (AEs)(Baseline to Week 27)
- Change in glycated hemoglobin (HbA1c)(Baseline to Week 12)
- Change in SMPG profile(Baseline to Week 26)
- Change in fasting plasma glucose (FPG)(Baseline to Week 26)
- Participants with HbA1c below 7%(Week 12 and 26)
- Number of participants with hypoglycemia events(Baseline to Week 26)
- Change in Treatment satisfaction(Baseline to Week 26)
- Number of participants with health care utilization(Baseline to Week 26)
- Change in fasting SMPG(Baseline to Week 26)
- Percentage of participants requiring rescue therapy(Baseline to Week 12 and 26)