EUCTR2012-003580-21-BE进行中（未招募）1 期
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesA 52-week randomised, treat-to-target, placebo-controlled, double-blinded, parallelgroup, multinational, multi-centre trial - ADJUNCT ONE™
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,398
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Informed consent obtained
- •- Type 1 diabetes mellitus= 12 months
- •- Male or female, aged 18 – 75 years
- •- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment = 6 months
- •- Stable insulin treatment for the last 3 month 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, selftitration of insulin and attend all scheduled visits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
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
- •- Severe neuropathy, in particular autonomic neuropathy, i.e.
- •gastroparesis, as judged by the investigator.
- •- Uncontrolled/ untreated blood pressure at screening > 160 mmHg for systolic or > 100 mmHg for diastolic
- •- History of acute or chronic pancreatitis.
- •- Screening calcitonin value > 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)
研究者
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