NCT00469092已完成4 期
A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, Oceania and South America.
This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
- •Ongoing stable treatment with metformin for at least 2 months
- •Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
- •Insulin naive
- •HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)
排除标准
- •Metformin contraindication according to local practice
- •TZD (thiazolidinedione) treatment for the last 5 months before trial start
- •Systemic treatment with any corticosteroid 3 months before trial start
- •Any disease or condition which according to the Investigator would interfere with the trial
研究组 & 干预措施
BIAsp 30
Experimental
干预措施: biphasic insulin aspart (Drug)
BIAsp 30
Experimental
干预措施: metformin (Drug)
BIAsp 30
Experimental
干预措施: glimepiride (Drug)
Glargine
Active Comparator
干预措施: insulin glargine (Drug)
Glargine
Active Comparator
干预措施: metformin (Drug)
Glargine
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
Glycosylated Haemoglobin A1c (HbA1c)
时间窗: After 26 weeks of treatment
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
次要结局
- 9-point Self-measured Plasma Glucose Profiles(After 26 weeks of treatment)
- Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)(After 26 weeks of treatment)
- Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)(After 26 weeks of treatment)
- Number of Hypoglycaemic Episodes(Weeks 0-26)
- Number of Subjects Reporting Treatment Emergent Adverse Events(Weeks 0-26)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT00474045Novo Nordisk A/S470
已完成
2 期
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma PatientsAcquired Bleeding DisorderTraumaNCT01563523Novo Nordisk A/S283
已完成
2 期
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With InhibitorsCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsNCT03196284Novo Nordisk A/S26
已完成
3 期
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome ResultsDiabetesDiabetes Mellitus, Type 2NCT01179048Novo Nordisk A/S9,341
已完成
3 期
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia BCongenital Bleeding DisorderHaemophilia BNCT01386528Novo Nordisk A/S13