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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
- ACRONYMGRADUATE
- 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 DTSQ
o EQ5D
- Timepoints0, 6, 12, 24 weken
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. H.W. Valk, de
- CONTACT for SCIENTIFIC QUERIESDr. H.W. Valk, de
- 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


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