NCT01326026已完成3 期
A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)
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
- 222
- 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 and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
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 (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
- •Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
- •HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- •BMI (Body Mass Index) no higher than 45.0 kg/m^2
排除标准
- •Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
- •Suffer from a life threatening disease (e.g. cancer)
- •Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
研究组 & 干预措施
IDeg Simple
Experimental
干预措施: insulin degludec (Drug)
IDeg Step wise
Experimental
干预措施: insulin degludec (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
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 26)
- Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 26 + 7 days follow up)
- 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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