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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Amit Tirosh, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02016846
First received: December 15, 2013
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Glucocorticoid Induced Hyperglycemia
Drug: Liraglutide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Glucose levels 2 hours after 75 gr OGTT [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Intervention
Liraglutide, tapered from 0.6 mg/day to 1.8 mg/day.
Drug: Liraglutide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Amit Tirosh, Dr, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02016846     History of Changes
Other Study ID Numbers: 0209-13
Study First Received: December 15, 2013
Last Updated: December 22, 2013
Health Authority: Israel: Clalit Health Services

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

ClinicalTrials.gov processed this record on October 20, 2014