NCT01135992已完成3 期
A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
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
- 143
- 试验地点
- 1
- 主要终点
- HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •HbA1c maximum 10 % by central laboratory analysis
- •Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
排除标准
- •Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
- •Cardiovascular disease (CVD) 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 within the last six months prior to Visit 1
- •Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
- •Known or suspected hypersensitivity to trial products or related products
研究组 & 干预措施
IGlar/IDeg
Experimental
干预措施: insulin glargine (Drug)
IDeg 3TW
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
HbA1c (Glycosylated Haemoglobin)
时间窗: Week 4 and Week 16
HbA1C at week 4 and 16
次要结局
- Fasting Plasma Glucose (FPG)(Week 4 and Week 16)
- Change in Body Weight(Week 0, Week 4, Week 16)
- Rate of Treatment Emergent Adverse Events (AEs)(Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW))
- Rate of Confirmed Hypoglycaemic Episodes(Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW))
- Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW))
研究者
研究点 (1)
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