The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,398
- 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 globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.
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
- •- Type 1 diabetes mellitus for 12 months or longer
- •- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
- •- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
- •- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
- •- Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
排除标准
- •- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
- •- Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic
- •- History of acute or chronic pancreatitis
- •- Screening calcitonin value equal to or above 50 ng/L
- •- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
- •- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
研究组 & 干预措施
Liraglutide 0.6 mg + insulin
干预措施: liraglutide (Drug)
Liraglutide 1.2 mg + insulin
干预措施: liraglutide (Drug)
Liraglutide 1.8 mg + insulin
干预措施: liraglutide (Drug)
Liraglutide placebo 0.6 mg + insulin
干预措施: placebo (Drug)
Liraglutide placebo 1.2 mg + insulin
干预措施: placebo (Drug)
Liraglutide placebo 1.8 mg + insulin
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 52
Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Change From Baseline in Body Weight
时间窗: Week 0, week 52
Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Change From Baseline in Total Daily Insulin Dose
时间窗: Week 0, week 52
Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.
次要结局
- Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes(Weeks 0-52)