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

Primary Purpose

Glucocorticoid Induced Hyperglycemia

Status

Unknown status

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Liraglutide

Placebo

About this trial

This is an interventional prevention trial for Glucocorticoid Induced Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rabin Medical Center, Beilinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Glucose levels 2 hours after 75 gr OGTT

Secondary Outcome Measures

Full Information

NCT ID

NCT02016846

First Posted

December 15, 2013

Last Updated

December 22, 2013

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02016846

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glucocorticoid Induced Hyperglycemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Glucose levels 2 hours after 75 gr OGTT

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amit Tirosh, MD

Phone

+972.50.8191078

tiroshamit@gmail.com

Facility Information:

Facility Name

Rabin Medical Center, Beilinson Campus

City

Petah Tiqva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amit Tirosh, MD

tiroshamit@gmail.com

12. IPD Sharing Statement

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

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