EUCTR2021-004452-42-NO招募中1 期
An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study). - STABIL-NOR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, also including activities to determine suitability for the trial as for example the screening for eligibility.
- •2. Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.
- •3. BMI = 30 kg/m2 or = 27 kg/m2 with the presence of prediabetes determined with either fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/l and/or HbA1c between 39-47 mmol/mol measured on two occasions at least 24 hours apart.
- •These measures will be done at the V1 and the V2 visit, or alternatively a measurement of FPG or HbA1c within the borders of prediabetes performed in the regular clinical treatment during last 2 weeks before screening can be used as the first of the two occasions.
- •4. A diagnosis within the schizophrenia-spectrum according to International classification of diseases version - 10 (ICD-10): F 20, F 22, F 23, F 25, F 28, F 29.
- •5.AP drug use for at least 3 weeks prior to starting study medication and a treatment plan/recommendation for further AP drug use for at least the next 6 months. Antipsychotic drug discontinuation during the trial will not result in exclusion from further participation in the study.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. With relation to glycemic regulation:
- •a. Type 1 or Type 2 diabetes present or in history.
- •b. HbA1c >48 mmol/mol.
- •c. Latent autoimmune diabetes in adults (LADA).
- •d. Treatment with a GLP-1 receptor agonist last 6 months before screening.
- •e. Treatment with insulin or other glucose-lowering drug(s) last 3 months before screening.
- •2. Thyreoid stimulating hormone (TSH) within the normal range-Haukeland university hospital: 11-19 years: 0,51-4,30 mIU/L, >20 years: 0,40-4,50 mIU/L.
- •3. Medical or surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.
- •4. Safety criteria:
- •a. A personal or family history of medullary thyreoid cancer or multippel endokrin neoplasi 2 (MEN 2).
- •b. A history of pancreatitis during the last 12 months before inclusion.
- •c. A history of myocardial infarction/instable angina/stroke during the last 12 months before inclusion.
- •d. A prior serious hypersensitivity reaction to semaglutide or to any of the excipients or otherwise as specified in the SPC of Wegovy.
- •e. A history of eating disorders defined: a specialist diagnosed eating disorder of ICD-10 F50 last ten years.
- •f. Woman of childbearing potential (WOCBP) who are not using adequate contraceptive methods (ref. appendix 4, section 10.4.2). Contraception must be continued for 6 months after the stop of study medication.
- •g. Breastfeeding.
- •h. Disorders, unwillingness or inability which in the investigator’s opinion might jeopardize the subject’s safety or compliance with the protocol.
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