Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 811
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Primary objectives :
- To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
- To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
Secondary objectives :
- To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.
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 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
1
Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin
干预措施: Insulin Glargine (Drug)
1
Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin
干预措施: Insulin Glulisine (Drug)
1
Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin
干预措施: Metformin (Drug)
2
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin
干预措施: Insulin Glargine (Drug)
2
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin
干预措施: Insulin Glulisine (Drug)
2
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin
干预措施: Metformin (Drug)
3
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
干预措施: Insulin Glargine (Drug)
3
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
干预措施: Insulin Glulisine (Drug)
3
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
干预措施: Metformin (Drug)
3
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
干预措施: insulin secretagogue (Drug)
结局指标
主要结局
HbA1c
时间窗: From the beginning to the end of the study
24-hour blood glucose levels
时间窗: From the beginning to the end of the study
symptomatic hypoglycemia (diurnal and nocturnal)
时间窗: From the beginning to the end of the study
Severe hypoglycemia (diurnal and nocturnal),
时间窗: From the beginning to the end of the study
Insulin doses
时间窗: From the beginning to the end of the study
次要结局
- Vital signs(From the beginning to the end of the study)
- Adverse events(From the beginning to the end of the study)