Does liraglutide (GLP-1 receptor agonist) change glucose tolerance in antipsychotic-treated patients?

Phase 1

• Conditions: Dysglycaemia, schizophrenia, paranoid psycosis, schizotypal disorder; MedDRA version: 18.1Level: LLTClassification code 10036481Term: Pre-diabetesSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-000121-31-DK
• Lead Sponsor: Prof., dr. med. Anders Fink-Jensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-21
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Informed oral and written consent
- Diagnosed with schizophrenia, paranoid psychosis or schizotypal disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
- and on stable antipsychotic treatment with either clozapine or olanzapine for at least 6 months (without dose change for at least 30 days)
- Stable co-medications for at least 30 days.
- Age =18 years and =65 years
- Stable weight (defined as less than 5% change in weight over the last 3 month before inclusion)
- BMI =27 kg/m2
- Dysglycaemia:
1) HbA1c: 43 mmol/mol = HbA1c = 47 mmol/mol, or
2) Impaired fasting glucose (IFG): Fasting plasma glucose (FPG): 6.1 mmol/l = FPG = 6.9 mmol/l and HbA1c < 48 mmol/mol, or
3) Impaired glucose tolerance (IGT): two-hour plasma glucose after 75-g oral glucose tolerance test >7.8 mmol/l with a FPG < 7.0 mmol/l and HbA1c < 48 mmol/mol

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) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Compulsory treatment
- Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
- Subjects treated with corticosteroids or other hormone therapy (except estrogens)
- Any active substance abuse or dependence for the past 6 months (except for nicotine)
- Impaired hepatic function (liver transaminases >2 times upper normal limit)
- Impaired renal function (se-creatinine >150 µM and/or macroalbuminuria)
- Impaired pancreatic function (acute or chronic pancreatitis and/or amylase >2 times upper normal limit)
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
- Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
- Any condition that the investigator feels would interfere with trial participation
- Receiving any investigational drug within the last 3 months
- Use of weight-lowering pharmacotherapy within the preceding 3 month
- Type 1 or 2 diabetes HbA1c = 48 mmol/mol or on treatment with antidiabetic medication

Study & Design

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