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

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Glucocorticoid Induced Hyperglycemia

Treatments: Drug: Liraglutide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02016846

0209-13

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Liraglutide