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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02016846
Recruitment Status : Unknown
Verified December 2013 by Amit Tirosh, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Amit Tirosh, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Glucocorticoid Induced Hyperglycemia Drug: Liraglutide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Intervention
Liraglutide, tapered from 0.6 mg/day to 1.8 mg/day.
Drug: Liraglutide



Primary Outcome Measures :
  1. Glucose levels 2 hours after 75 gr OGTT [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016846


Contacts
Contact: Amit Tirosh, MD +972.50.8191078 tiroshamit@gmail.com

Locations
Israel
Rabin Medical Center, Beilinson Campus Not yet recruiting
Petah Tiqva, Israel
Contact: Amit Tirosh, MD       tiroshamit@gmail.com   
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: Amit Tirosh, Dr, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02016846     History of Changes
Other Study ID Numbers: 0209-13
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists