Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 892
- 主要终点
- Percentage of patients with at least one episode of hypoglycemia
研究概览
简要总结
Primary Objective:
-To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs).
Secondary Objective:
- To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.
- To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).
- To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).
- To evaluate the insulin doses change.
- To evaluate the weight change.
- To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence.
- To descriptively evaluate the safety profile.
- To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration).
- Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:
- Age
- Duration of diabetes
- Baseline treatment (OAD)
- Baseline HbA1c, FPG and PP
详细描述
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
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 70 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
Standard initial dose of insulin glargine
Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: INSULIN GLARGINE (Drug)
Standard initial dose of insulin glargine
Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: metformin (Drug)
Standard initial dose of insulin glargine
Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: acarbose (Drug)
Higher initial dose of insulin glargine
Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: INSULIN GLARGINE (Drug)
Higher initial dose of insulin glargine
Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: metformin (Drug)
Higher initial dose of insulin glargine
Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before.
干预措施: acarbose (Drug)
结局指标
主要结局
Percentage of patients with at least one episode of hypoglycemia
时间窗: 16 weeks
次要结局
- Change from baseline in Fasting Plasma Glucose(Baseline, 16 weeks)
- Change from baseline in Post Prandial Glucose(Baseline, 16 weeks)
- Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)(16 weeks)
- Change in body weight(Baseline, 16 weeks)
- Change from baseline in HbA1c(Baseline, 16 weeks)
- Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L])(Baseline, 16 weeks)
- Number of nocturnal hypoglycemic events(Baseline, 16 weeks)
- Percentage of patients achieving HbA1c <7%(16 weeks)
- Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L)(16 weeks)
- - Change in insulin dose(Baseline, 16 weeks)
- Number of severe hypoglycemic events(Baseline, 16 weeks)