临床试验/NCT01713530

NCT01713530已完成3 期

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 274 人开始时间: 2013年2月21日最近更新: 2018年4月2日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 274
试验地点: 1
主要终点: Change From Baseline in HbA1c (%)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

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

•Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
•Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
•HbA1c 7.0% - 10.0%
•Body mass index (BMI) less than or equal to 40.0 kg/m^2

排除标准

•Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
•Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
•Chronic disorder or disease which might jeopardise safety or compliance
•Malignant neoplasms
•Recurrent severe hypoglycaemia

研究组 & 干预措施

IDegAsp BID+/-OADs

Experimental

干预措施: insulin degludec/insulin aspart (Drug)

IDeg OD plus IAsp +/-OADs

Experimental

干预措施: insulin degludec (Drug)

IDeg OD plus IAsp +/-OADs

Experimental

干预措施: insulin aspart (Drug)

结局指标

主要结局

Change From Baseline in HbA1c (%)

时间窗: Week 0, week 26

Change from baseline in HbA1c (%) after 26 weeks of treatment

次要结局

Incidence of Treatment Emergent Adverse Events (TEAE)(Weeks 0-26)
Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
Number of Treatment Emergent Hypoglycaemic Episodes(During Weeks 0-26)
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes(Weeks 0-26)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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