EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

What Was Tested

This registered phase 4 trial tested Liraglutide.

Informed consent will be obtained.

IRB approval of the study will be obtained. 300 subjects (employees or spouses covered by their EHP) will be randomized 1:1:1 to receive either an obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM therapy (N=100), or the current usual care approach to general health management (N=100).

It had three arms (groups): Obesity-centric approach + AOM (experimental), Obesity-centric approach without AOM (experimental) and Usual care approach (Comorbidity-centric approach) (active comparator).

Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.

The registry classes the interventions as drug and other.

More on the Plan

In recognition of the biologic basis and seriousness of obesity, several professional health associations and organizations worldwide recognize obesity as a disease10.

Currently, estimates for these costs are $210 billion per year.

That's a return of $5.60 for every $1 invested15.

Unfortunately, these patients have a much higher risk of developing coronary artery disease and cancer.

Who Took Part

74 actual participants took part.

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.

Examples of who could join: Gender: men and women. Ethnicity: all ethnic groups. Age: ≥18, \< 75 years. Obesity, BMI ≥30.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes or known latent autoimmune diabetes of adulthood (lada); current glucocorticoid therapy; currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2020-09-01 with completion listed for 2022-08-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Change in Body Weight Between Baseline and 12 Months (time frame: 12 Months). Mean Change in A1C (time frame: 12 Months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 74 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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