Assessing the efficacy and safety of the GLP1-agonist liraglutide in patients who developed diabetes as a consequence of the use of anti-psychotic drugs

• Conditions: antipsychotic-drugs-associated diabetes mellitus; MedDRA version: 17.0Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 100000004861; MedDRA version: 17.0Level: LLTClassification code 10012612Term: Diabetes mellitus non insulin-depSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-005395-18-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-10
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified