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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT01399645
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide-metformin vs insulin-metformin — DRUG
    Liraglutide (Victoza, Novo Nordisk) at a dose of 0.6 - 1.8 mg subcutaneous per day. Insulin glargine (Lantus, Sanofi-Aventis) with an initial bedtime starting dose of 10 IU.

Study Details

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).

Key Dates

Start date
May 31, 2011
Status verified
Aug 2014
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide-Metformin
    Liraglutide (Victoza, Novo Nordisk) at a dose of 0.6 - 1.8 mg subcutaneous per day until the end of the study. All subjects will be given metformin with a starting dose of 500 mg in one tablet twice daily given before or during meals for the duration of the study.
  • Experimental: Insulin-Metformin
    Insulin glargine (Lantus, Sanofi-Aventis) with an initial bedtime starting dose of 10 IU. The patients will be taught to increase their insulin dose by 1 unit each day until achieving an FPG ≤ 7.0 mmol/L. All subjects will be given metformin with a starting dose of 500 mg in one tablet twice daily given before or during meals for the duration of the study.

Primary Outcome Measure

To determine liver fat fraction evolution induced by liraglutide and insulin [ Time Frame: 12 weeks ]

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