NCT01845259

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

April 14, 2013

Last Update Submit

May 4, 2016

Conditions

Impaired Glucose Tolerance Associated With Drugs

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Change in Glucose tolerance (measured by area under the curve (AUC) for plasma glucose (PG) excursion following a 4-hour 75 g Oral Glucose Tolerance Test (OGTT))

    Baseline - 16 weeks

Secondary Outcomes (8)

  • Dysglycaemia

    Baseline - 16 weeks

  • Body weight

    Every 4 weeks from baseline - 16 weeks

  • Secretion of incretin hormons, insulin sensitivity and beta cell function

    Baseline - 16 weeks

  • Body composition

    Baseline - 16 weeks

  • Lipid profile and liver function

    Every 4 weeks from baseline - 16 weeks

  • +3 more secondary outcomes

Other Outcomes (5)

  • Alcohol use

    Every 4 weeks from baseline - 16 weeks

  • Changes i dietary and exercise records

    Every 4 weeks from baseline - 16 weeks

  • Proteomic fingerprinting

    Every 4 weeks from baseline - 16 weeks

  • +2 more other outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

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

Drug: Liraglutide

Liraglutide placebo

PLACEBO COMPARATOR

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

Drug: Liraglutide Placebo

Interventions

LiraglutideDRUG

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

Also known as: Victoza, GLP-1 agonist
Liraglutide
Liraglutide PlaceboDRUG

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

Also known as: Placebo
Liraglutide placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed oral and written consent
  • Diagnosed with schizophrenia, schizotypal disorder or paranoid psychosis according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
  • and on stable antipsychotic treatment with either clozapine or olanzapine for at least 6 months (without dose change for at least 30 days)
  • Stable co-medications for at least 30 days.
  • Age ≥18 years and ≤65 years
  • BMI ≥27 kg/m2
  • Dysglycaemia (IFG, i.e. fasting plasma glucose level from 6.1 mmol/L to 6.9 mmol/L or IGT, i.e. two-hour glucose levels \> 7.8 mmol/L on the 75-g oral glucose tolerance test with a fasting plasma glucose of less than 7.0 mmol/L and HbA1c \< 48 mmol/mol or HbA1c: 43 mmol/mol ≤ HbA1c ≤ 47 mmol/mol)

You may not qualify if:

  • Compulsory treatment
  • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
  • Subjects treated with corticosteroids or other hormone therapy (except estrogens)
  • Any active substance abuse or dependence for the past 6 months (except for nicotine)
  • Impaired hepatic function (liver transaminases \>2 times upper normal limit)
  • Impaired renal function (se-creatinine \>150 μM and/or macroalbuminuria)
  • Impaired pancreatic function (acute or chronic pancreatitis and/or amylase \>2 times upper normal limit)
  • Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
  • Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg)
  • Any condition that the investigator feels would interfere with trial participation
  • Receiving any investigational drug within the last 3 months
  • Use of weight-lowering pharmacotherapy within the preceding 3 month
  • Type 1 or 2 diabetes with HbA1c \> 6.5%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Centre Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 28601891DERIVED

  • 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.

    PMID: 25023888DERIVED

  • 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.

    PMID: 24667381DERIVED

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Anders Fink-Jensen, MD, DMSci

    Psychiatric Centre Rigshospitalet

    PRINCIPAL INVESTIGATOR

  • Tina Vilsbøll, MD, DMSci

    Diabetes Research Division, Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, DMSci

Study Record Dates

First Submitted

April 14, 2013

First Posted

May 3, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

DK(1)