NCT01392573已完成3 期
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
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
- 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 Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.
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
- Double (Participant, Investigator)
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
- •Subjects with type 2 diabetes
- •HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
- •Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
- •BMI (Body Mass Index) more than or equal to 27 kg/m^2
排除标准
- •Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
- •Impaired liver function
- •Impaired renal function
- •Screening calcitonin equal to or above 50 ng/l
- •Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
- •Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
- •Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
- •Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
- •History of chronic pancreatitis or idiopathic acute pancreatitis
研究组 & 干预措施
IDegLira + metformin
Experimental
IDegLira was injected subcutaneously once daily for 26 weeks.
干预措施: insulin degludec/liraglutide (Drug)
IDeg + metformin
Experimental
IDeg was injected subcutaneously once daily for 26 weeks.
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
次要结局
- Change in Body Weight(Week 0, week 26)
研究者
研究点 (1)
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