NCT02098395已完成3 期
A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial
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
- 835
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.
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 75 Years（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 procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, aged equal to or greater than 18 years at the time of signing informed consent
- •Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
- •Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
- •Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
- •HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
排除标准
- •Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
- •Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed
- •Known proliferative retinopathy or maculopathy requiring acute treatment
- •Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
- •Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
- •History of acute or chronic pancreatitis
- •Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
研究组 & 干预措施
Liraglutide 1.8 mg + insulin
Experimental
干预措施: liraglutide (Drug)
Liraglutide 1.2 mg + insulin
Experimental
干预措施: liraglutide (Drug)
Liraglutide 0.6 mg + insulin
Experimental
干预措施: liraglutide (Drug)
Liraglutide placebo 0.3 ml + insulin
Placebo Comparator
干预措施: placebo (Drug)
Liraglutide placebo 0.2 ml + insulin
Placebo Comparator
干预措施: placebo (Drug)
Liraglutide placebo 0.1 ml + insulin
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 26
Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
次要结局
- Change From Baseline in Body Weight(Week 0, Week 26)
- Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes(Weeks 0-26)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01232491Novo Nordisk A/S611
终止
2 期
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MethotrexateInflammationRheumatoid ArthritisNCT01636843Novo Nordisk A/S298
终止
2 期
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa BiologicsInflammationRheumatoid ArthritisNCT01636817Novo Nordisk A/S239
已完成
3 期
Comparison of NN1250 With Insulin Glargine in Type 2 DiabetesDiabetes Mellitus, Type 2DiabetesNCT01006291Novo Nordisk A/S687
已完成
2 期
Recombinant Factor VIIa in Acute Intracerebral HaemorrhageAcquired Bleeding DisorderIntracerebral HaemorrhageNCT00426803Novo Nordisk A/S400