NCT00420095已完成4 期
Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
研究概览
简要总结
The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Clinically diagnosed type 1or type 2 diabetes for at least 2 months
- •Aged between 18 and 70 (inclusive)
- •Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
- •Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1
- •Compliance with diet and insulin therapy and performs regular blood glucose monitoring
排除标准
- •Have used oral antidiabetic agents within 30 days prior to entry into the study
- •Receive a total daily dose of insulin >2 units/kilogram
- •Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
- •Have a body mass index >35 kilograms per square meter (kg/m2)
- •Receive chronic systemic glucocorticoid therapy
研究组 & 干预措施
1
Active Comparator
Human insulin mix 30/70
干预措施: Human insulin 30/70 (Drug)
2
Experimental
Insulin lispro low mix
干预措施: Insulin lispro low mix (Drug)
结局指标
主要结局
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
时间窗: Baseline and 12 weeks of each treatment
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
次要结局
- Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment(Baseline and at 12 weeks of each treatment)
- Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment(Baseline and 12 weeks of each treatment)
- Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment(Baseline and 12 weeks of each treatment)
- Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%(12 weeks of each treatment)
- Number of Participants With Laboratory Parameters Significantly Different From Baseline(Baseline and 12 weeks of each treatment)
- Hypoglycemia Rate Per Participant Per 30 Days(over 12 weeks of each treatment period)
研究者
研究点 (1)
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