Effects of Liraglutide in Young Adults With Type 2 DIAbetes (LYDIA)

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

There are recent advances in therapies for the treatment of Type 2 Diabetes Mellitus (T2DM) which include the GLP1 analogues and the DPP IV inhibitors.

It had two arms (groups): Liraglutide (experimental) and Sitagliptin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The focus of health care policy and research has lagged behind this substantive shift in the profile of T2DM towards younger populations.

Clinical Burden of T2DM in the young The onset of T2DM in younger adults and youth represents an extreme phenotype that magnifies the disease profile observed in older adults.

For example, those diagnosed with T2DM under 40 years are more likely to be classified with Class II or Class III obesity (≥35 kg/m2), have a multigenerational family history of T2DM, lead a sedentary lifestyle and be of minority ethnic origin \[7\].

In contrast, older adults with T2DM had less than four times the risk of developing an MI compared with control subjects.

Who Took Part

90 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Capacity to provide informed consent before any trial-related activities. Individuals aged 18 - 60 years inclusive. BMI ≥ 30 kg/m2 (≥27 kg/m2 for South Asians or other BME populations). On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for ≥ 3months. No prescribed thiazolidinediones within the last 3 months.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: \< 18 years old; absolute contraindications to mri; type 1 diabetes (identified through c-peptide analysis).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2013-12-16 with completion listed for 2017-09-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in peak early diastolic strain rate measured by cardiac MRI (time frame: Change from baseline peak end diastolic strain rate at 26 weeks).

It also tracked 13 secondary outcomes, for example Composite of standard biochemical variables, Composite chronic low-grade inflammation and adiposity, Composite Endothelial Function, Composite Standard Anthropometric variables, MRI defined adiposity and Composite Lifestyle variables.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 90 people.

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

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