Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty liver who are resistant to metformin, treatment with liraglutide in combination with metformin will cause an absolute reduction in liver fat superior to insulin-metformin treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Canadian Heads of Academic Radiology-GE Healthcare Development Award; Centre de Recherche du Centre Hospitalier de l'Université de Montréal; Diabetes Québec; Radiological Society of North America
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Liraglutide; Metformin

Criteria

Inclusion Criteria:

• Are 18 y.o. or older at screening (first visit),

• Are ambulatory,

• Are known for type 2 diabetes with criteria of failure of metformin monotherapy, metformin-sulfonylurea, metformin-repaglinide combined therapy defined as HbA1C ≥6.5,

• Abdominal girth > 94 cm for men and > 80 cm for women,

• Understand French or English instruction,

• Able to comprehend and willingness to provide voluntary consent.

Exclusion Criteria:

• Have any contra-indications for MRI (such as metallic implants, pacemaker or claustrophobia),

• Have type 1 diabetes or have had episodes of ketoacidosis,

• Have any major debilitating disease including malignant disorders,

• Have had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease,

• Patients having received insulin within 3 months prior to screening,

• Have a serum creatine above >150 mmol/L or estimated GFR < 30 mL/min,

• Women seeking pregnancy,

• Have a history of chronic liver disease other than NAFLD, including HBV and HCV infection, hemochromatosis, Wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis,

• Current or previous use of oral or injectable corticosteroids,

• Have excessive alcohol intake, defined as a daily limit of 30 g (3 drinks) for men and 20 g (2 drinks) for women.