Liraglutide is an effective and safe treatment modality in metformin-treated patients suffering from schizophrenia with anti-psychotic drugs-related diabetes mellitus.
ID
Bron
Verkorte titel
Aandoening
anti-psychotic-drug diabetes mellitus
diabetes mellitus veroorzaakt door antipsychotica
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary end point of this study is the change in HbA1c from baseline to ‘end of trial’
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Liraglutide is an effective and safe treatment modality in metformin-treated patients suffering from schizophrenia with anti-psychotic drugs-related diabetes mellitus.
Onderzoeksopzet
0, 6, 12, 24 weken
Onderzoeksproduct en/of interventie
• 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.
Algemeen / deelnemers
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Wetenschappers
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4111 |
| NTR-old | NTR4352 |
| Ander register | HW de Valk : U1111-1144-0576 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |