Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Liraglutide.

Experimental Approach: The investigators will use a prospective, single blind, placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12 weeks.

The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide for 24 weeks.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

Subjects will receive placebo for 12 weeks.

The registry classes the interventions as drug.

More on the Plan

This will be a prospective, single-blind, placebo-controlled study with a crossover design.

Visit Procedures: After a 1 month run-in period during which there will be no changes in medications, physical activity or diet, patients will be randomly divided into 2 groups of 6 patients each.

Subjects have a 50:50 chance of being randomized to either group 1 or group 2.

Group 1 patients will then be switched from liraglutide to placebo injections for another 12 weeks.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and single-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant.

It started in 2014-05 with completion listed for 2022-12-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Changes in unfolded protein response markers (time frame: baseline, 6 months, 9 months).

It also tracked 6 secondary outcomes, for example Insulin sensitivity, Glucose control, Energy expenditure, Body weight, Body composition and Beta cell function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 12 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.