Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

Plain-language guide to NCT02147925: phase 4 randomized trial of Insulin Glargine and Liraglutide, fatty liver & elevated liver enzymes, 75 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02147925
Phase: phase 4
Status: completed
Start: 2014-08
Completion (planned or actual): 2017-04
Participants: 75 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Non-alcoholic Fatty Liver Disease
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Liraglutide for fatty liver & elevated liver enzymes.

It had three arms (groups): Liraglutide (active comparator), Insulin glargine (active comparator) and Sitagliptin (active comparator).

Liraglutide combined with metformin.

Insulin glargine combined with metformin.

Sitagliptin combined with metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 75 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Clinically diagnosed simple liver steatosis. 30-75 years old. Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: type 1 diabetes; any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis; history or family history of medullary thyroid cancer(mtc), or multiple endocrine neoplasia type 2(men-2).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the fatty liver & elevated liver enzymes participants and staff both knew the treatment.

It started in 2014-08 with completion listed for 2017-04.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Intrahepatic lipids (IHL) (time frame: 26-week).

It also tracked 3 secondary outcomes, for example Change of abdominal subcutaneous adipose tissue(SAT), Change of visceral adipose tissue(VAT) and Change in hemoglobin A1c(HbA1c).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Liraglutide in 75 people with fatty liver & elevated liver enzymes.

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.