A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese

What Was Tested

This registered phase 4 trial tested Exenatide.

The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese.

It had two arms (groups): Exenatide and Metformin (experimental) and BIAsp30 and Metformin (active comparator).

Exenatide in Combination With Metformin.

BIAsp30 in Combination With Metformin.

The registry classes the interventions as drug.

More on the Plan

Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance.

In this study, the researchers suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: A signed and dated informed consent form obtained from the subject before any study related procedures take place. Age ≥18 years to ≤65 years at Visit 1. The subject has a new diagnosis of type 2 diabetes without any treatment. BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: the subject has a history of type 1 diabetes or a secondary form of diabetes; the subject has received an anti-diabetic drug before the screening visit; treatment with systemic steroids 2 months prior to screening.

How the Study Was Run

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

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

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

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

It started in 2017-02 with completion listed for 2021-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rate of Inducing Diabetes Remission (time frame: At the end of 12-week treatment). Change of Rate of Maintaining Diabetes Remission (time frame: 3,6,12,24,36 months after 12-week treatment). Time of Maintaining Diabetes Remission (time frame: up to 36 months after 12-week treatment).

It also tracked 10 secondary outcomes, for example Change of Blood Pressure, Change of Heart Rate, Change of Weight, Change of Waistline, Change of Glycosylated Hemoglobin and Change of Pancreatic Beta-cell Function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 200 people.

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

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