Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Liraglutide.

But it does not work for all youth, especially African-Americans.

It had two arms (groups): Metformin (active comparator) and Metformin and liraglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

Among minority youth, African-Americans have the highest complication rates, yet the reasons underlying this health disparity are not fully understood.

Furthermore, current treatment options are limited, and African-American youth have high treatment failure rates.

However, little is known about how genes or gut bacteria may affect youth, especially African-Americans.

To treat this aggressive disease, it is also necessary to simultaneously evaluate new therapeutic options, such as combination therapy of metformin with liraglutide in youth at highest risk for complications.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 12 years up to 25 years.

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

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: pregnancy or breastfeeding; allergy to study medications; allergy to milk protein.

How the Study Was Run

Design: 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.

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

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-05-09 with completion listed for 2022-05-20.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in Absolute Gluconeogenesis From Baseline to 12 Weeks (time frame: Baseline to 12 weeks).

It also tracked 8 secondary outcomes, for example Change in Glucose Production Rate From Baseline to 12 Weeks, Change in GIP AUC During OGTT and Meal Absorption, Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption, Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks, Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks and Change in Insulin AUC Concentrations During an OGTT and Meal Absorption.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Liraglutide in 24 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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