E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
antipsychotic-drugs-associated diabetes mellitus |
diabetes mellitus veroorzaakt door het gebruik van anti-psychotica |
|
E.1.1.1 | Medical condition in easily understood language |
diabetes caused by the use of antipsychotic drugs |
type suikerziekte die veroorzaakt is door het gebruik van antipsychotische medicijnen |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029505 |
E.1.2 | Term | Non-insulin-dependent diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012612 |
E.1.2 | Term | Diabetes mellitus non insulin-dep |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore the efficacy of liraglutide in terms of glycaemic control assessed by HbA1c. |
Effect onderzoeken van liraglutide op de glychemische huishouding op basis van het Hab1c |
|
E.2.2 | Secondary objectives of the trial |
• 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.
|
Effect onderzoeken van liraglutide op cardiovasculaire riscofactoren zoals gewicht, intra-abdominaal vet (gemeten door CT scan) bij obese patienten met diabetes veroorzaakt door het gebruik van antipsychotica
Onderzoeken of deze groep patienten compliance heeft bij het gebruik van dit middel
Onderzoeken van de mogelijke psychiatrische veranderingen |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
Getekend toestemmingsformulier voordat er een studiehandeling heeft plaats gevonden
Mannen of vrouwen van 18 jaar of ouder
Diabetes ontwikkeld door het gebruik van anti-psychotica voor op zijn minst 6 maanden
Gebruik van metformine voor de behandeling van diabetes
HbA1c >7.0% - ≤ 10.0 mmol/l (53 – 86 mmol/mol)
BMI 30 – 45 kg/m2
In staat zijn om het protocol te kunnen begrijpen en te volgen |
|
E.4 | Principal exclusion criteria |
• Any type of diabetes present before the use of anti-psychotic drugs
• Use of glucose-lowering medication other than metformin
• cardiovascular event in the last 6 months
• Reduced cardiac function (LVEF < 30%)
• evidence of active retinopathy
• 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
|
Type diabetes ontstaan voor het gebruik van anti-psychotica
Gebruik van glucoseverlagende middelen anders dan Metformine
Doorgemaakt cardiovasculair event in de afgelopen 6 maanden
Verminderde hartfunctie (LVEF < 30%)
Bewijs van actieve retinopathie
Gecontrolleerde of ongecontrolleerde hypertensie (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
Nierfunctiestoornis (MDRD < 30 ml/min)
Leverfunctiestoornissen (ALT en/of AST > 3 keer hoger dan normaalgrens)
Voorgeschiedenis met chronische pancreatitis of aanwezige acute pancreatitis
Bekende gevoeligheid voor het te onderzoeken middel of onderdelen daarvan
Vrouwen die zwanger zijn, zwanger willen worden of borstvoeding geven en geen adequate voorbehoedsmiddelen gebruiken
Indien er deelgenomen is aan een andere studie met medicatie die korter dan 90 dagen geleden
Indien psychaiter concludeert dat patient niet capabel is voor deelname
Patienten waarbij vanuit kan worden gegaan dat ze niet therapietrouw zullen zijn
Actieve doodswens
Gebruik van cortocosteroiden
Persoonlijke of familiegeschiedenis met MEN2
Bekende alcohol- of narcotic abuses
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of this study is the change in HbA1c from baseline to ‘end of trial’ |
Verandering van HbA1c van de baseline tot het einde van de studie. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the study |
Aan het einde van de studie |
|
E.5.2 | Secondary end point(s) |
Efficacy
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
|
Effect wordt gemeten door de veranderingen te meten in nuchtere glucose, gewicht, BMI, heup- en buikomtrek, bloeddruk, lipiden, abdominaal vet
Veiligheid wordt gemeten door compliance te meten, SAE/AE 's meten
Veranderingen in psyche worden gemeten d.m.v. CAPE, CGI en PANS score
Patientenervaringen worden gemeten d.m.v. vragenlijsten PAID, SF-12, DTSQ, EQ5D |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of this study and meanwhile |
Aan het einde van de studie en tussendoor |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is 24 weeks after the last patient was randomised |
Het einde van de studie is 24 weken nadat de laatste patient is gerandomiseerd |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |