Status:
COMPLETED
Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Diabetes Québec
Conditions:
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ab...
Detailed Description
Background: Non-alcoholic fatty liver disease (NAFLD) can now be identified in 70% of patients with type 2 diabetes. Insulin can be introduced at any point in the treatment of diabetes, but is potenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01399645
Start Date
May 1 2011
End Date
June 1 2014
Last Update
August 27 2014
Active Locations (1)
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1
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2W 1T7