Trial · Interventional

CompletedPhase 2Registry data

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

Short name LIRAINS

NCTNCT01399645Other idCE09.159

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 35 participants (actual)
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Other
Design: Randomized · Single masking
Countries: 1 country
Canada
Start: May 2011
Primary completion: Jun 2014
Completion: Jun 2014
First posted: 22 Jul 2011 (estimated)
Last update posted: 27 Aug 2014 (estimated)
Conditions: Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis · Type 2 Diabetes

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20112012201320142015

Ph 2
LIRAINS
NCT01399645
May 2011 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Liraglutide-metformin vs insulin-metforminDrug

Arms2

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 outcomes1

Outcomes the sponsor listed as primary.

To determine liver fat fraction evolution induced by liraglutide and insulin
Time frame · 12 weeks
Registry description
Improvement in liver steatosis defined by change in liver fat fraction as measured by MRI and MR spectroscopy at baseline and 12 weeks of treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

7 results

Effects of Insulin Glargine and Liraglutide Therapy on Liver Fat as Measured by Magnetic Resonance in Patients With Type 2 Diabetes: A Randomized Trial.

Tang et al. 2015Diabetes carecited by 104

PMID 25813773DOI 10.2337/dc14-2548PUB-25813773

Full text at the publisher7 results

Publisher page See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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