Who are we?


Signup for

Online registration

Log in to register
your trial

Search a trial




van CCT (UK)

van CCT (UK)

Onderzoek naar de effecten van het medicijn liraglutide bij patiλnten met een type suikerziekte (diabetes) die veroorzaakt is door het gebruik van antipsychotische medicijnen.

- candidate number15863
- NTR NumberNTR4352
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2013
- Secondary IDsU1111-1144-0576 HW de Valk
- Public TitleOnderzoek naar de effecten van het medicijn liraglutide bij patiλnten met een type suikerziekte (diabetes) die veroorzaakt is door het gebruik van antipsychotische medicijnen.
- Scientific TitleEffects of GLP1 agonist liRAglutiDE in patients with antispychotic-drUgs-associATEd diabetes mellitus
- hypothesisLiraglutide is an effective and safe treatment modality in metformin-treated patients suffering from schizophrenia with anti-psychotic drugs-related diabetes mellitus.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteria• Informed consent obtained before any trial related activities
• Males or females aged 18 years or older
• Diabetes mellitus developed while on anti-psychotic drugs for at least six months
• Use of metformin for the treatment of diabetes
• HbA1c >7.0% - ≤ 10.0 mmol/l (53 – 86 mmol/mol)
• BMI 30 – 45 kg/m2
• Regarded capable to understand and follow the protocol
- Exclusion criteria• Any type of diabetes present before the use of anti-psychotic drugs
• Use of glucose-lowering medication other than metformin
• No cardiovascular event in the last 6 months
• Reduced cardiac function (LVEF < 30%)
• No evidence of active retinopathy
• No controlled or uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
• Renal failure (MDRD < 30 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 intend 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 or 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-aug-2016
- Target number of participants50
- Interventions• To explore the efficacy of liraglutide in terms of glycaemic control assessed by HbA1c.

b. Secondary Objectives
• To explore the effect of liraglutide on cardiovascular risk factors, body weight and intra-abdominal fat content using CT-scans in obese patients with antipsychotics-associated diabetes mellitus
• To explore feasibility of liraglutide in the treatment of antipsychotic drugs- associated diabetes and obesity in patients suffering from severe mental illness in terms of compliance with the treatment regimen
• To explore possible change in psychiatric symptoms during treatment with liraglutide in severe mental illness using questionnaires.
- Primary outcomeThe primary end point of this study is the change in HbA1c from baseline to ‘end of trial’
- Secondary outcomeEfficacy
o Change in fasting glucose
o Change in body weight and BMI
o Change in waist and hip circumferences and waist hip ratio
o Change in blood pressure
o Change in lipid levels
o Change in abdominal fat content ( abdominal CT-scan)

Safety/ Feasibility
o Compliance with use of drug liraglutide (number of injection vials used)
o (Serious) Adverse events during liraglutide use

Change in psychiatric symptoms
o CAPE-score
o CGI- score
o PANS-score

Patient-reported outcomes
o PAID (problem areas in diabetes)
o SF-12
o EQ5D
- Timepoints0, 6, 12, 24 weken
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Novo Nordisk
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-dec-2013 - 2-feb-2014

  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar