2024-518746-24-00尚未招募2 期
Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration of metabolic state in prediabetic or diabetic patients with schizophrenia treated with the antipsychotic compounds clozapine or olanzapine?
Psykiatrisk Center Kobenhavn1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)
研究概览
简要总结
The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, aged 18 years to 65 years, who have initiated treatment with clozapine or olanzapine.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
- 分配方式
- Randomized
- 主要目的
- From trial start until all data have been analysed
- 盲法
- Double (Carer, Subject, Monitor, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Initiated current daily treatment with clozapine or olanzapine, respectively, within 60 months & Diagnosed with prediabetes or type 2 diabetes, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be confirmed on a different day. Type 2 diabetes: HbA1c 48-57 mmol/mol or fasting plasma glucose (FPG) 6.9-9.9 mM or 2h OGTT > 11 mM (although FPG and HbA1c might still be under the diagnostic range). The test result has to be confirmed on a different day.
排除标准
- •Suicidal behavior and/or plasma HbA1c > 57 mmol/mol (tested twice) in which case the patient will be excluded from the study and transferred to general practitioner or hospital for diabetic treatment & no diabetic medication is allowed except for the trial medicine.
结局指标
主要结局
The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)
The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)
次要结局
- Changes in body weight, hip, waist circumference, blood pressure, heart rate, plasma insulin, C-peptide, glucagon, incretin hormones, lipid profile, proteomics and bone markers, insulin sensitivity, beta-cell function (evaluated by HOMA. Body composition and bone density evaluated by DXA-scan), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life.
研究者
Anders Fink-Jensen
Scientific
Psykiatrisk Center Kobenhavn
研究点 (1)
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