NCT01068678已完成3 期
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)
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
- 460
- 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 North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.
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
- •Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
- •Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -Insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
- •HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- •Body Mass Index (BMI) below or equal to 45.0 kg/m^2
排除标准
- •Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
- •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 (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
- •Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
研究组 & 干预措施
IDeg 3 times weekly (3TW)
Experimental
干预措施: insulin degludec (Drug)
IGlar OD
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 26
Change from baseline in HbA1c after week 26
次要结局
- Change in Body Weight(Week 26)
研究者
研究点 (1)
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