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

Plain-language guide to NCT01399645: phase 2 randomized trial of Insulin Glargine and Liraglutide, fatty liver & elevated liver enzymes, 35 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01399645
Phase: phase 2
Status: completed
Start: 2011-05
Completion (planned or actual): 2014-06
Participants: 35 (actual)
Design: randomized, single-blind, treatment
Conditions studied: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Type 2 Diabetes
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Glargine and Liraglutide for fatty liver & elevated liver enzymes.

It had two arms (groups): Liraglutide-Metformin (experimental) and Insulin-Metformin (experimental).

The registry classes the interventions as drug.

More on the Plan

Before and post-treatment MRI and MRS will be read blindly for quantification of steatosis.

Methods: Thirty-six patients will be randomized to either study group.

Expected results: The results of this study will provide preliminary data for a large scale study comparing the 2 therapeutic regimen and establish the utility of MRI and MRS to monitor medical treatment in diabetic patients with fatty liver disease.

Who Took Part

The registry lists 35 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Are 18 y.o. or older at screening (first visit),. 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.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: have any contra-indications for mri (such as metallic implants, pacemaker or claustrophobia),; have any major debilitating disease including malignant disorders,; patients having received insulin within 3 months prior to screening,.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

In this single-blind Insulin Glargine study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2011-05 with completion listed for 2014-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To determine liver fat fraction evolution induced by liraglutide and insulin (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Liraglutide in 35 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Liraglutide compound page, Fatty liver & elevated liver enzymes research.

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.