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Liraglutide Efficacy on Glucocorticoid Induced Hyperglycemia in Patients High Risk for Diabetes

NCT ID: NCT02016846

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glucocorticoid Induced Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intervention

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

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Interventions

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Liraglutide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amit Tirosh

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rabin Medical Center, Beilinson Campus

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Amit Tirosh, MD

Role: CONTACT

Phone: +972.50.8191078

Email: [email protected]

Facility Contacts

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Amit Tirosh, MD

Role: primary

Other Identifiers

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0209-13

Identifier Type: -

Identifier Source: org_study_id