NCT00282451已完成4 期
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.
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 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic subjects
- •Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
- •HbA1c at least 12%
- •Willing and able to perform self blood glucose monitoring (SMBG)
排除标准
- •History of drug or alcohol dependence
- •Receipt of any investigational drug within the last month prior to this trial
- •Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
- •Severe uncontrolled hypertension
- •Recurrent severe hypoglycemia as judged by investigator
- •Any disease or condition, which the Investigator feels, would interfere with the trial
结局指标
主要结局
HbA1c
时间窗: At Visit 6 (14 weeks)
次要结局
- Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
4 期
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetes Mellitus, Type 2DiabetesNCT01697631Novo Nordisk A/S131
已完成
1 期
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy VolunteersHealthyDiabetesNCT01487811Novo Nordisk A/S50
已完成
3 期
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 DiabetesDiabetes Mellitus, Type 1DiabetesNCT00312104Novo Nordisk A/S325
已完成
4 期
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal InsulinDiabetes Mellitus, Type 2DiabetesNCT00669864Novo Nordisk A/S293
已完成
4 期
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2DiabetesNCT00600366Novo Nordisk A/S71