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Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?

NCT01845259 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

  • Impaired Glucose Tolerance Associated With Drugs

Interventions

DRUG

Liraglutide

Once a day 1,8 mg subcutaneous injection for 16 weeks

DRUG

Liraglutide Placebo

Once a day 1,8 mg subcutaneous injection for 16 weeks

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Psychiatric Centre Rigshospitalet

    lead OTHER

Principal Investigators

  • Anders Fink-Jensen, MD, DMSci · Psychiatric Centre Rigshospitalet

  • Tina Vilsbøll, MD, DMSci · Diabetes Research Division, Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-03-31
Completion
2017-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845259 on ClinicalTrials.gov