drugset / Trial / NCT01845259
Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?
Phase 2
Unknown
103 enrolled
Psychiatric Centre Rigshospitalet
University Hospital, Gentofte, Copenhagen · collabUniversity of Cambridge · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major clinical problems among antipsychotic-treated patients. Especially two of the most efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic disturbances and can rarely be replaced by other drugs due to the effectiveness of the compounds. Glucagon-like peptide 1 (GLP-1) has improved glycemic control among patients with type 2 diabetes. The study will investigate whether the beneficial effects of GLP-1 analogues on glycemic control in type 2 diabetic patients, can be extended to a population of non-diabetic, dysglycemic psychiatric patients, receiving antipsychotic medical treatment.
Timeline
- Start
- 2013-04
- Primary completion
- 2016-03
- Completion
- 2017-03
Publications
- Larsen JR, Vedtofte L, Jakobsen MSL, Jespersen HR, Jakobsen MI, Svensson CK, Koyuncu K, Schjerning O, Oturai PS, Kjaer A, Nielsen J, Holst JJ, Ekstrom CT, Correll CU, Vilsboll T, Fink-Jensen A. Effect of Liraglutide Treatment on Prediabetes and Overweight or Obesity in Clozapine- or Olanzapine-Treated Patients With Schizophrenia Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jul 1;74(7):719-728. doi: 10.1001/jamapsychiatry.2017.1220.
- Sharma AN, Ligade SS, Sharma JN, Shukla P, Elased KM, Lucot JB. GLP-1 receptor agonist liraglutide reverses long-term atypical antipsychotic treatment associated behavioral depression and metabolic abnormalities in rats. Metab Brain Dis. 2015 Apr;30(2):519-27. doi: 10.1007/s11011-014-9591-7. Epub 2014 Jul 15.
- Larsen JR, Vedtofte L, Holst JJ, Oturai P, Kjaer A, Correll CU, Vilsboll T, Fink-Jensen A. Does a GLP-1 receptor agonist change glucose tolerance in patients treated with antipsychotic medications? Design of a randomised, double-blinded, placebo-controlled clinical trial. BMJ Open. 2014 Mar 25;4(3):e004227. doi: 10.1136/bmjopen-2013-004227.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liraglutide | Peptide | 1.8 mg | Subcutaneous |