The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

What Was Tested

In this phase 4 trial, researchers set out to test Dulaglutide for fat loss, obesity & body recomposition.

This study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between Beinaglutide and Dulaglutide in type 2 diabetes with overweight or or Obesity.

It had two arms (groups): Beinaglutide (experimental) and Dulaglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

About 2/3 of patients with type 2 diabetes are overweight or obese in China, several studies had confirmed that overweight and obesity could cause type 2 diabetes.

GLP-1 receptor agonist could control diabetes meanwhile loss the patient weight.

This is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two GLP-1 receptor agonist, Beinaglutide and Dulaglutide, in type 2 diabetes with overweight or Obesity.

The primary endpoint is the change from baseline to week 16 in HbA1c.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age between 18 to 70 years old from all sex;. BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）;. Volunteer to participate in the study with informed consent;.

The full record lists 4 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes or other specific types of diabetes;; taking drugs of glp-1 receptor agonist、tzds and sglt2 inhibitor within 3 months of screening;; taking insulin or insulin analogues more than 7 days within 3 months of screening;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Nothing was hidden in this open-label Dulaglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2021-05-01 with completion listed for 2023-12-31.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: haemoglobin A1c(HbA1c) (time frame: From baseline to 16 week).

It also tracked 12 secondary outcomes, for example Weight loss, GLucose, Body Mass Index(BMI), Waistline, Hipline and Serum total cholesterol.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 120 people with fat loss, obesity & body recomposition.

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

More context: the Dulaglutide compound page, Fat loss, obesity & body recomposition research.