NCT00614055已完成2 期
A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
- •Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (SPC)
- •HbA1c, 7.0 - 11.0 % (both inclusive)
- •Body Mass Index (BMI), 25.0 - 37.0 kg/m^2 (both inclusive)
排除标准
- •Metformin contraindication according to local practice
- •Thiazolidinedione (TZD) treatments within the previous three months prior to Visit 1
- •Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
- •Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
研究组 & 干预措施
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
Insulin glargine
Active Comparator
干预措施: metformin (Drug)
SIAC 30 (B)
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
SIAC 30 (B)
Experimental
干预措施: metformin (Drug)
SIAC 45 (B)
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
SIAC 45 (B)
Experimental
干预措施: metformin (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 16
Change from baseline in HbA1c after 16 weeks of treatment
次要结局
- Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 16 + 5 days follow up)
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 16)
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 16)
- Rate of Nocturnal Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
- Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)(Week -4, Week 16)
- Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)(Week -4, Week 16)
- Laboratory Safety Parameters (Biochemistry): Serum Creatinine(Week -4, Week 16)
- Vital Signs: Diastolic Blood Pressure (BP)(Week 0, Week 16)
- Vital Signs: Systolic Blood Pressure (BP)(Week 0, Week 16)
- Vital Signs: Pulse(Week 0, Week 16)
- Physical Examination(Week 0, Week 8, Week 16)
- Rate of Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
研究者
研究点 (1)
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