NCT02016846

Brief Summary

Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity. However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will improve glucose metabolism in patients with high risk for diabetes morbidity, treated with glucocorticoids.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

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

First Submitted

Initial submission to the registry

December 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 15, 2013

Last Update Submit

December 22, 2013

Conditions

Glucocorticoid Induced Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Glucose levels 2 hours after 75 gr OGTT

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Intervention

ACTIVE COMPARATOR

Liraglutide, tapered from 0.6 mg/day to 1.8 mg/day.

Drug: Liraglutide

Interventions

LiraglutideDRUG
Intervention
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Planned treatment with T. Prednisone in dosage \>0.5 mg/kg for two weeks or more.
  • Age \>18 years
  • Body mass index \>27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome.

You may not qualify if:

  • Glycosylated hemoglobin A1c \>6.5%
  • Diagnosis of diabetes mellitus or treatment with anti-glycemic drug
  • Pancreatitis (acute or chronic) in the past
  • Active malignancy
  • Medullary thyroid carcinoma or multiple endocrine neoplasm type 2 of the patient or of 1st degree relative
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Campus

Petah Tikva, Israel

Location

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Amit Tirosh, MD

CONTACT

+972.50.8191078tiroshamit@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 20, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

IL(1)