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 trial - ADJUNCT ONE*

ovo Nordisk0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- 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
•- 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

•- 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
•- Known proliferative retinopathy or maculopathy requiring treatment
•- 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)

发起方

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