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?

Phase 1

• Conditions: Schizophrenia spectrum disorder; MedDRA version: 20.0Level: LLTClassification code 10052792Term: Schizophrenia, undifferentiated typeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-000102-28-DK
• Lead Sponsor: Mental Healt Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-13
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1.Informed oral and written consent.
2.Diagnosed with a schizophrenia spectrum disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association.
3.Initiating current daily treatment with clozapine or olanzapine, respectively, within 60 months.
4.Age 18 years to 65 years (both included).
5.Body mass index (BMI) =25 kg/m2.
6.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.

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 4

Exclusion Criteria

1.Acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the CGI-S scale).
2.Coercive measures
3.Females of child-bearing potential who are pregnant, breastfeeding, or have the intention of becoming pregnant.
4.Women who are not willing to use an adequate contraceptive during the full length of the study.
5.Patients treated with corticosteroids or other hormone therapy (except oestrogens).
6.Any active substance abuse or dependence (except for nicotine).
7.Impaired hepatic function (plasma liver transaminases >3 times upper normal limit).
8.Impaired renal function (serum creatinine >150 µmol/l).
9.Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit).
10.Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months.
11.Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg.
12.Any condition that the investigator feels would interfere with trial participation.
13.Receiving any experimental or pre-marketing drug within the last 3 months.
14.Use of diabetes medication or weight-lowering pharmacotherapy within the preceding 3 months.
15.Known type 1 diabetes.
16.Suicidal behavior as judged by the investigator and based on clinical evaluation. At all contact with patient attendance (except DXA scanning visits, please see Table 1) possible suicidality will be evaluated according to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action.
17.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.
18.Any known contraindication towards the treatment with semaglutide.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified