A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.
Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin 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
- •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).
- •The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
- •Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
排除标准
- •Participated in NN1250-3643 and treated with insulin glargine
- •Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
- •Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
- •Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula] at end of treatment in NN1250-3643.
研究组 & 干预措施
IDeg (non-randomised)
干预措施: insulin degludec (Drug)
IDeg + IAsp
干预措施: insulin degludec (Drug)
IDeg + IAsp
干预措施: insulin aspart (Drug)
IDeg + liraglutide
干预措施: insulin degludec (Drug)
IDeg + liraglutide
干预措施: liraglutide (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
时间窗: week 0, week 26
Values for change in HbA1c from baseline to 26 weeks of treatment period.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(week 0, week 26)
- Change From Baseline in Body Weight(week 0, week 26)
- Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes(Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.)