NCT01461577已完成4 期
A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
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
- 89
- 试验地点
- 1
- 主要终点
- Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
研究概览
简要总结
Primary Objective:
- To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.
Secondary Objective:
- To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
详细描述
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
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
- 30 Years 至 75 Years（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
Experimental
Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm
干预措施: INSULIN GLARGINE HOE 901 (Drug)
结局指标
主要结局
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
时间窗: 24 weeks
次要结局
- Responder rate (HbA1c levels <6.5% and <7%)(24 weeks)
- Weight change from baseline(24 weeks)
- Responder rate (HbA1c levels <7%) without severe hypoglycemia(24 weeks)
- Changes of fasting plasma glucose (FPG) levels from baseline(24 weeks)
- Changes of beta cell marker: C-peptide from baseline(24 weeks)
- Changes of Lipid profile: Lipid profile from baseline(24 weeks)
- Total insulin dose (per kg body weight)(24 weeks)
- Evaluation of patient's treatment satisfaction(24 weeks)
- Number of patients with hypoglycemia(up to 24 weeks)
- Number of patients with treatment-emergent adverse events(up to 24 weeks)
研究者
研究点 (1)
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