The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes; A 26-weeks randomised, insulin capped, placebo-controlled, double-blinded, parallelgroup, multinational, multi-centre trial - ADJUNCT TWO*

ovo Nordisk0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•-Informed consent obtained
•-Male or female, aged *18 years
•-Type 1 diabetes mellitus* 12 months
•-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% (53-86 mmol/mol) both inclusive

•- 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 >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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