NCT01006291已完成3 期
A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 687
- 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 Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.
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 mellitus (diagnosed clinically) for at least 6 months
- •Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
- •HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
- •Body Mass Index (BMI) below or equal to 40.0 kg/m^2
排除标准
- •Cancer and medical history of cancer hereof
- •Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
- •Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- •Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)
研究组 & 干预措施
IDeg OD FF
Experimental
干预措施: insulin degludec (Drug)
IDeg OD
Experimental
干预措施: insulin degludec (Drug)
IGlar OD
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment
次要结局
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 26)
- Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
- Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
研究者
研究点 (1)
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