1. To assess the efficacy of liraglutide in patients with schizophrenia and diabetes ona. Glycaemic controlb. Body weightc. Cardiovascular risk factors (blood pressure, lipids)2. To assess the safety of liraglutide in these patients3. To assess the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Change in HbA1c (end of trial * baseline value)
Secondary outcome
* Change in BMI and intra-abdominal fat mass (CT scan)
* Change in cardiovascular risk factors
o Lipid profile
o Blood pressure
* Safety
o Hypoglycaemia
o Adverse events
* Compliance
* Patient-reported outcomes
o Diabetes-related (PAID, EQ5D, SF12, DTSQ)
o Psychiatry-related (CAIG, PANSS)
* Continuous glucose monitoring
Background summary
Patients treated with antipsychotic drugs have an increased incidence of
diabetes and the metabolic syndrome, attributable to a large degree to the use
of anti-psychotic drugs. Anti-psychotic drugs are strongly obesiogenic and
diabetogenic. Diabetes and the metabolic syndrome are held responsible for the
increased incidence of cardiovascular diseases in treated patients with
schizophrenia and help to explain their decreased life expectancy. Diabetes is
difficult to treat in these patients, also because of limited compliance.
Liraglutide as a GLP1-agonist holds promise as a new therapeutic avenue,
combining glycaemic efficacy and weight-losing properties with low risk of
side effects and easy therapeutic scheme.
Study objective
1. To assess the efficacy of liraglutide in patients with schizophrenia and
diabetes on
a. Glycaemic control
b. Body weight
c. Cardiovascular risk factors (blood pressure, lipids)
2. To assess the safety of liraglutide in these patients
3. To assess the compliance with liraglutide use in these patients
4. To asses patient reported outcomes including general ones and
schizophrenia-related ones
5. To explore the effect of liraglutide on the intra-abdominal fat mass as
assessed by one -slice CT-scan
Study design
The study is designed as a six-month, randomised (1:1), double-blind,
parallel-armed, placebo-controlled clinical trial comparing liraglutide versus
liraglutide-placebo on top of usual metformin therapy.
Intervention
This is a randomised placebo-controlled parallel arm intervention study in
metformin-treated patients with schizophrenia and anti-psychotic drugs-related
diabetes mellitus. During a 6-month trial, patients will receive either
liragutide 1.8 mg sc (rapidly uptitrated) or placebo sc. There are 25 patients
in each treatment group.
Study burden and risks
Particpation in this trial requires 5 visits to the hospital, eacht takning one
hour.
Blood sampling will be done 4 times.
Liraglutide is associated with an increased risk of abdominal complaints (like
nausea; moderate risk)
Subcutaneous injedtion can lead to lcocal irritation of small bleeding
(moderate risk)
Heidelberglaan 100
Utrecht 3584 cx
NL
Heidelberglaan 100
Utrecht 3584 cx
NL
Listed location countries
Age
Inclusion criteria
Severe mental disorder (schizophrenia and schizophrenia-related; these disorders are defined with one of the following DSM-codes: 295.10, 295.20, 295.30, 295.40, 295.60, 295.70, 295.90, 297.1, 297.3, 298.8, 298.9)
* Informed consent obtained before any trial related activities
* Males or females aged 18 years or older
* Diabetes mellitus developed while on anti-psychotic drugs, Diabetes Mellitus for at least six months
* Use of metformin for the treatment of diabetes for at least three months
* HbA1c >7.0% - * 10.0 mmol/l (53 * 69 mmol/mol)
* BMI 30 * 45 kg/m2
* Regarded capable to understand and follow the protocol
Exclusion criteria
Any type of diabetes present prior to the use of anti-psychotic drugs (including type 1 diabetes)
* Use of glucose-lowering medication other than metformin, current use of within 3 months prior to start of the study
* Any cardiovascular event in the last 6 months
* Reduced cardiac function (LVEF < 30%)
* Any evidence of active retinopathy
* Uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
* Compromised renal function (MDRD < 60 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 intending 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 and 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 during the trial
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005395-18-NL |
| CCMO | NL47408.041.13 |