A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

What Was Tested

The trial (phase 3) is built around Exenatide and Dulaglutide.

It had three arms (groups): one (experimental), one (experimental) and Dulaglutide+Metformin (active comparator).

The registry classes the interventions as drug.

More on the Plan

A total of 64 weeks.

Who Took Part

600 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: Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V4). Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: people diagnosed with type 1 diabetes or other types of diabetes; more than 14 days of continuous insulin use in the 6 months prior to screening; acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization .

How the Study Was Run

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

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.

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

It started in 2024-07-17 with completion listed for 2026-10-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: Baseline, Week 26).

It also tracked 7 secondary outcomes, for example HbA1c, fasting plasma glucose (FPG), fasting insulin, Homeostatic Model Assessment of Insulin Resistance(HOMA-IR), Health Survey Short Form (SF-36) and blood pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Dulaglutide in 600 people.

With 600 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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