Effects of GLP1 agonist liraglutide in patients with antipsychotic-drugs-associated diabetes mellitus

Phase 4

Withdrawn

• Conditions: Diabetes Mellitus; 10018424

• Registration Number: NL-OMON40321
• Lead Sponsor: Interne geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Severe mental disorder (schizophrenia and schizophrenia-related; these disorders are defined with one of the following DSM-codes: 295.10, 295.20, 295.30, 295.40, 295.60, 295.70, 295.90, 297.1, 297.3, 298.8, 298.9)
* Informed consent obtained before any trial related activities
* Males or females aged 18 years or older
* Diabetes mellitus developed while on anti-psychotic drugs, Diabetes Mellitus for at least six months
* Use of metformin for the treatment of diabetes for at least three months
* HbA1c >7.0% - * 10.0 mmol/l (53 * 69 mmol/mol)
* BMI 30 * 45 kg/m2
* Regarded capable to understand and follow the protocol

Exclusion Criteria

Any type of diabetes present prior to the use of anti-psychotic drugs (including type 1 diabetes)
* Use of glucose-lowering medication other than metformin, current use of within 3 months prior to start of the study
* Any cardiovascular event in the last 6 months
* Reduced cardiac function (LVEF < 30%)
* Any evidence of active retinopathy
* Uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
* Compromised renal function (MDRD < 60 ml/min)
* Liver function abnormalities (ALT and/or AST > 3 times the upper limit of normal)
* History of chronic pancreatitis or previous acute pancreatitis
* Known or suspected hypersensitivity to trial product(s) or related product(s)
* Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant or is not using adequate contraceptive methods
* Participation in another trial or receipt of any investigational medicinal product within 90 days prior to screening
* Subjects who are considered incapable for inclusion by their physicians
* Subjects who are considered inadequate for liraglutide administration themselves and lack network of support
* Subjects who are actively suicidal
* Recurrent use of corticosteroids
* Personal or family history of medullary thyroid carcinoma and patients with multiple endocrine neoplasia type 2 (MEN2)
* Known or suspected abuse of alcohol or narcotics during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Change in HbA1c (end of trial * baseline value)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Change in BMI and intra-abdominal fat mass (CT scan)<br /><br>* Change in cardiovascular risk factors<br /><br>o Lipid profile<br /><br>o Blood pressure<br /><br>* Safety<br /><br>o Hypoglycaemia<br /><br>o Adverse events<br /><br>* Compliance<br /><br>* Patient-reported outcomes<br /><br>o Diabetes-related (PAID, EQ5D, SF12, DTSQ)<br /><br>o Psychiatry-related (CAIG, PANSS)<br /><br>* Continuous glucose monitoring</p><br>