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

NCT01399645 | Completed Phase 2

• 1 other identifier: CE09.159
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 absolute reduction in liver fat superior to insulin-metformin treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Type 2 Diabetes

Keywords

Randomized trial; Open label; Pilot study; Single center

Outcome Measures

Primary Outcomes (1)

• To determine liver fat fraction evolution induced by liraglutide and insulin

  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.

  12 weeks

Study Arms (2)

Liraglutide-Metformin

EXPERIMENTAL

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.

Drug: Liraglutide-metformin vs insulin-metformin

Insulin-Metformin

EXPERIMENTAL

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.

Drug: Liraglutide-metformin vs insulin-metformin

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.

Also known as: Liraglutide, Victoza, Insulin glargine, Lantus

Insulin-Metformin; Liraglutide-Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Diabetes Québec: collaborator
• Radiological Society of North America: collaborator
• Canadian Heads of Academic Radiology-GE Healthcare Development Award: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T7, Canada

Location

Related Publications (1)

• Tang A, Rabasa-Lhoret R, Castel H, Wartelle-Bladou C, Gilbert G, Massicotte-Tisluck K, Chartrand G, Olivie D, Julien AS, de Guise J, Soulez G, Chiasson JL. Effects of Insulin Glargine and Liraglutide Therapy on Liver Fat as Measured by Magnetic Resonance in Patients With Type 2 Diabetes: A Randomized Trial. Diabetes Care. 2015 Jul;38(7):1339-46. doi: 10.2337/dc14-2548. Epub 2015 Mar 26.

  PMID: 25813773 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Liraglutide; Insulin Glargine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• An Tang, MD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

CA (1)