NCT00191581已完成3 期
Comparison of 2-Hour Postprandial Blood Glucose Excursion in Response to a Standard Test Meal in Insulin-Requiring Diabetic Patients Treated Twice Daily With Either Insulin Lispro Mix 50/50 or Human Insulin Mix 50/50
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50
研究概览
简要总结
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
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
- •Men and women who have had either type 1 or type 2 diabetes (World Health Organization[WHO]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
- •Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
- •Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit
- •Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
- •Have given informed consent to participate in this study in accordance with local regulations.
排除标准
- •{1] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
- •[2] Receive a total daily dose of insulin >2 units/kg.
- •[3] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
- •[4] Have a body mass index >35 kg/m
- •[5] Have serum creatinine > the upper limit of normal (ULN), as determined by a local laboratory.
结局指标
主要结局
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50
次要结局
- Effects on HbA1c values obtained at the end of each treatment period;
- Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50.
- Effects on fasting blood glucose values obtained throughout the study;
- The secondary objectives of the study are:
- To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to
- Assess HbA1c values at baseline and after treatment with human insulin mix 50/50.
研究者
研究点 (2)
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