NCT02606357已完成4 期
Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
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
- 242
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
- To evaluate the percentage of patients achieving target of HbA1c ˂7%.
- To evaluate the change in fasting plasma glucose (FPG).
- To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
- Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
详细描述
The total duration of study period per patient is up to 6 months.
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
HOE901
Experimental
HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, 6 months
次要结局
- - Percentage of patients achieving target of HbA1c <7%(6 months)
- - Change from baseline in body weight(Baseline, 3 months and 6 months)
- - Change in the titration doses used (if any)(6 months)
- - Percentage of patients with hypoglycemic events(Baseline, 6 months)
- - Time to reach control(6 months)
- - Change from baseline in fasting plasma glucose values(Baseline, 3 months, and 6 months)
- - Number of patients with adverse events(Baseline, 6 months)
- - Change in dose of insulin glargine(3 months and 6 months)
研究者
研究点 (1)
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