EUCTR2012-003580-21-NL进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,404
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 7.0-9.5% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-80 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 (except for insulin), which in the investigator’s opinion could interfere with the glycaemic control or affect the subject’s safety
- •- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 1 month) prior to screening
- •- Existing hypoglycaemic unawareness as judged by the investigator
- •- Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening
- •- Known proliferative retinopathy or maculopathy requiring treatment and/or 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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已完成
3 期
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, parallelgroup, multinational, multi-centre trial10018424diabetesNL-OMON38605ovo Nordisk50
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The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesMedDRA version: 18.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2012-003580-21-PLovo Nordisk A/S1,404