Liraglutide Efficacy on Glucocorticoid Induced Hyperglyce... | NCT02016846

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

NCT02016846

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Dec 24, 2013Estimated

Enrollment

36Estimated

Phase

Phase 3

Conditions

Glucocorticoid Induced Hyperglycemia

Interventions

Liraglutide
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 15, 2013

First Submission Date that Met QC Criteria

Dec 15, 2013

First Posted Date

Dec 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2013

Last Update Posted Date

Dec 24, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Intervention	Active Comparator	Liraglutide, tapered from 0.6 mg/day to 1.8 mg/day.	Drug: Liraglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug		Intervention
Placebo

Measure	Description	Time Frame
Glucose levels 2 hours after 75 gr OGTT		6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amit Tirosh, MD	Contact	+972.50.8191078		tiroshamit@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center, Beilinson Campus		Petah Tikva			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

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Browse Branches

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