NCT00613951已完成2 期
A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, 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
- 182
- 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 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, 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 months at a stable maximally tolerated dose or at least half maximally 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) treatment within previous 3 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 (except for conditions associated with type 2 diabetes) 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
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)
BIAsp 30
Active Comparator
干预措施: biphasic insulin aspart (Drug)
BIAsp 30
Active Comparator
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
- Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)(Week -4, Week 16)
- Vital Signs: Diastolic Blood Pressure (BP)(Week 0, Week 16)
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 16)
- Rate of Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
- Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 16 + 5 days follow up)
- Rate of Nocturnal Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
- Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)(Week -4, Week 16)
- Vital Signs: Systolic Blood Pressure (BP)(Week 0, Week 16)
- Vital Signs: Pulse(Week 0, Week 16)
- Physical Examination(Week -4, Week 8, Week 16)
- Laboratory Safety Parameters (Biochemistry): Serum Creatinine(Week -4, Week 16)
研究者
研究点 (1)
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