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Trial · Interventional

Status unknownPhase 2Registry data

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

Short name GREAT

NCTNCT01845259 (opens ClinicalTrials.gov in a new tab)Other idGLP-1 antipsychoticsOther id2013-000121-31Other idU1111-1128-3404

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
103 participants (actual)
Sponsor
Psychiatric Centre Rigshospitalet · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Apr 2013
Primary completion
Mar 2016
Completion
Mar 2017 (estimated)
First posted
3 May 2013 (estimated)
Last update posted
5 May 2016 (estimated)
Conditions
Impaired Glucose Tolerance Associated With Drugs

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015201620172018
  1. Ph 2

    GREAT

    NCT01845259

    Apr 2013 to est. Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • Liraglutide PlaceboDrug

Arms2

  • Experimental

    Liraglutide

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

  • Placebo comparator

    Liraglutide placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucose tolerance

    Time frame · Baseline - 16 weeks

    Registry description

    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))

Secondary outcomes(8)
  1. Dysglycaemia

    Time frame · Baseline - 16 weeks

    Registry description

    Change in dysglycaemia (Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT), combined IFG/IGT or diabetes)

  2. Body weight

    Time frame · Every 4 weeks from baseline - 16 weeks

  3. Secretion of incretin hormons, insulin sensitivity and beta cell function

    Time frame · Baseline - 16 weeks

    Registry description

    Evaluated by Homeostatic Model of Assessment (HOMA)

  4. Body composition

    Time frame · Baseline - 16 weeks

    Registry description

    Dual energy x-ray absorptiometry (DEXA)-scan

  5. Lipid profile and liver function

    Time frame · Every 4 weeks from baseline - 16 weeks

    Registry description

    Blood sample

  6. Psychopathology

    Time frame · Baseline - 16 weeks

    Registry description

    Schizophrenia Quality of Life Scale (SQLS), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I), Global Assessment of Function (GAF)

  7. Waist circumference

    Time frame · Every 4 weeks from baseline - 16 weeks

  8. Blood pressure

    Time frame · Every 4 weeks from baseline - 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

8 results

Effect of Liraglutide Treatment on Prediabetes and Overweight or Obesity in Clozapine- or Olanzapine-Treated Patients With Schizophrenia Spectrum Disorder: A Randomized Clinical Trial.

Larsen et al. 2017JAMA psychiatrycited by 174

PMID 28601891PMC5710254DOI 10.1001/jamapsychiatry.2017.1220PUB-28601891

Rights unknown8 results

More studies

2 studies on this page

Indexing hint: Animal study · 2015

GLP-1 receptor agonist liraglutide reverses long-term atypical antipsychotic treatment associated behavioral depression and metabolic abnormalities in rats.

Sharma et al. 2015Metabolic brain diseasecited by 53

PMID 25023888DOI 10.1007/s11011-014-9591-7PUB-25023888

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2014

Corrected

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.

Larsen et al. 2014BMJ opencited by 13

PMID 24667381PMC3975765DOI 10.1136/bmjopen-2013-004227PUB-24667381

Free to read · publisher termsCC BY-NC

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * Stable weight (defined as less than 5% change in weight over the last 3 month before inclusion) * 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) Exclusion Criteria: * 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% Also a group of healthy controls (n=10) will have the baseline examinations done. The healthy controls will be matched to our participants in regards to gender, BMI and age. The same inclusion and exclusion criteria will apply for these controls, except these participants are not allowed to have known psychiatric illness, receive anti-psychotic medications, or have a family history of type 2 diabetes (2 generations).

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