Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- HbA1c (mmol/mol)
研究概览
简要总结
To investigate whether the Glucagon Like Peptide 1 (GLP-1) Semaglutide (1.34 mg/ml) has preventive effect compared to placebo in the development of diabetes and Metabolic Syndrome in people with pre-diabetes, overweight and schizophrenia, who receive antipsychotic treatment.
Furthermore to investigate for an effect of Semaglutide compared to placebo on psychotic symptoms and quality of life in people with schizophrenia, prediabetes and overweight.
详细描述
Quality control:
Usual quality control procedures will be followed in accordance with the ICH Guideline for Good Clinical Practice (GCP). The GCP unit at OUH will be responsible for monitoring the study in accordance with GCP guidelines. This protocol will be submitted as part of the notification to the Danish Medicines Agency and the Scientific Ethical Committee for the Region of Southern Denmark. Data processing regarding the trial will be reported to the Region's list of on-going research projects via the Executive Secretariat at OUH. Furthermore, Novo Nordisk will be informed of the trial.
Randomization:
A total of 154 participants will be randomized: 77 participants will be randomized to the Semaglutide group and 77 participants will be randomized to the placebo group (randomization ratio 1:1). The participant is assigned a subject number when consent is obtained, inclusion and exclusion criteria have been reviewed and the participant otherwise meets the requirements for study participation and continues to participate in the study. A participant cannot be assigned more than one randomization number and this number cannot be used for other persons. Block randomization including blocks of either 4 or 6 randomization numbers will be used, and the randomisations list will be provided by the manufacturer of Semaglutide and placebo (Novo Nordisk). The randomization will take place via the RedCAP® module.
Treatment arm allocation will be concealed to investigators. Randomization codes will be delivered in closed envelopes, kept in Odense, Denmark, in a secure place with 24-hour access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The un-blinding will occur after the data analysis have ended and two blinded conclusions have been uploaded to clinicaltrials.gov based on the results of the primary and secondary outcomes defined in the SAP. The two blinded conclusions are added to the SAP.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)
- •Age between 18 and 60 years (both included)
- •Approved contraception for female participants
- •Treated by one of the OPUS clinics and or community psychiatry centers teams and community psychiatry in the Region of Southern Denmark or Zealand
- •Antipsychotic SGA treatment for at least 6 months
- •Stable co-medication for at least 1 month
- •HbA1c between 39-47 mmol/mol (both included). Two measurements with ≥3 month interval are required to confirm prediabetes. The first measurement is identified and obtained from patient journals, the second prior to enrolment
- •BMI ≥27 kg/m
- •Two weights with ≥3 month interval are required to confirm obesity
- •Capable of providing informed oral and written consent
排除标准
- •Diagnosis of diabetes (T1D or T2D) or a HbA1c >47 mmol/mol
- •Active malignant disease within the last 5 years
- •Pregnancy or breast feeding
- •Exceeding high risk consumption limit (>21 / 14 units of alcohol for men / women, respectively) or severe substance abuse
- •Unwillingness to allow home visits by a study nurse
- •Significant somatic disease: 1) end-stage renal failure (eGFR <15 ml/min); 2) elevated liver function tests (liver transaminases >2 times upper normal limit); 3) history of acute or chronic pancreatitis; 4) heart failure (NYHA class IV) or unstable angina pectoris or myocardial infarction with the last 6 months; 5) uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure >100 mm Hg)
- •Previous treatment with study drug or use of other weight reducing drugs within the last 6 month
- •Participation in other drug trials
- •Treatment with drugs approved for overt diabetes type
- •(Metformin not included)
- •Circumstances that the investigator believes will interfere with the trial
研究组 & 干预措施
Semaglutide
Active Comparator: Semaglutide injection once-weekly
The participants start with Semaglutide given as 0.25 mg subcutaneously per week for 4 weeks. Then, the dose is uptitrated to 0.5 mg subcutaneously per week for 4 weeks, whereafter the highest dose is reached: 1 mg subcutaneously per week until the end of the study (week 30).
Subjects, who experience side effects that hinder a stepwise increase in study drug, will remain at the highest possible tolerated dose for the rest of the study.
干预措施: Semaglutide, 1.34 mg/mL (Drug)
Placebo
Semaglutide-Placebo injections once weekly.
The Semaglutide-Placebo pens are produced by Novo Nordisk A/S and resemble the pens containing active drug.
Semaglutide-Placebo pens contain vehicle, i.e. no active drug. Semaglutide-Placebo is administered similarly to semaglutide. That is using the same uptitration regime and volume as the active comparator, Semaglutide.
Subjects, who experience side effects that hinder a stepwise increase in Semaglutide-Placebo, will remain at the highest possible tolerated dose for the rest of the study.
干预措施: Placebo (Other)
结局指标
主要结局
HbA1c (mmol/mol)
时间窗: 30 weeks
Absolute change in HbA1c reported as mmol/mol from baseline to end of treatment
次要结局
- Height(30 weeks)
- Weight(30 weeks)
- Chaneges in body mass index (BMI)(30 weeks)
- Medication Adherence Rating Scale(30 Weeks)
- Absolute change in systolic and diastolic blood pressure (mmHg)(30 weeks)
- EQ-5D-3L(30 Weeks)
- Waist circumference (cm)(30 weeks)
- Glycemic status (blood sampling)(30 weeks)
- Pro-atherosclerotic changes(30 Weeks)
- Plasma triglyceride(30 weeks)
- Cholesterol concentrations(30 weeks)
- Positive and Negative Symptom Scale 6(30 Weeks)
- Impact of Weight on Quality of Life-Lite(30 Weeks)
- The Simple Physical Activity Questionnaire(30 Weeks)
- Cardiovascular risk markers(30 Weeks)
- Short Form Survey version 2 (SF-36v2)(30 Weeks)
研究者
Jan Frystyk
Professor
Odense University Hospital