antipsychotic-drugs-associated diabetes mellitus MedDRA version: 17.0 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT Classification code 10012612 Term: Diabetes mellitus non insulin-dep System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Liraglutide
Product Name: Liraglutide
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 180 mm Hg and/or diastolic pressure > 100 mm Hg • Renal failure (MDRD 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of liraglutide in terms of glycaemic control assessed by HbA1c.;Secondary Objective: • 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 end point(s): The primary end point of this study is the change in HbA1c from baseline to ‘end of trial’;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: At the end of this study and meanwhile | — |
Countries
Netherlands
Contacts
Public ContactB. Silvius
University Medical Center
Outcome results
None listed