The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes. A 26 week randomised, insulin capped, placebo-controlled, double-blind, parallel group, multinational, multi-centre trial - ADJUNCT TWO™

ovo Nordisk A/S0 个研究点目标入组 804 人开始时间: 2014年3月17日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•2. Male or female, aged = 18 years at the time of signing informed consent
•3. Type 1 diabetes mellitus (as diagnosed clinically) = 12 months prior to Visit 1 (i.e. screening)
•4. Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment = 6 months prior to Visit 1 (i.e. screening)
•5. Stable insulin treatment = 3 months prior to Visit 1 (i.e. screening), as judged and documented by the investigator
•6. HbA1c 7.0–10.0 % (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53–86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
•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 744
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
•2. Use of any medication, which in the investigator’s opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject’s safety. Premix insulin is not allowed
•3. Known proliferative retinopathy or maculopathy requiring acute treatment
•4. Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
•5. Uncontrolled/ untreated blood pressure at screening (Visit 1) (after resting for 5 min) while sitting > 160 mmHg for systolic or >100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
•6. History of acute or chronic pancreatitis
•7. Screening (Visit 1) calcitonin value = 50 ng/L
•8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
•9. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

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