Comparing JY09 and Dulaglutide for Type 2 Diabetes Management

A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin

This study is testing whether two doses of a new diabetes medication called JY09 can help adults with type 2 diabetes manage their blood sugar better than the standard treatment, dulaglutide, when added to metformin.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Dongfang Biotech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06257966 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to evaluate the efficacy and safety of two doses of JY09, an Exendin-4Fc fusion protein, compared to dulaglutide as an add-on therapy to metformin in adults with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control. The study will enroll 600 participants and utilize a multicenter, randomized, open-label design with stratified block randomization based on baseline HbA1c levels. Participants will be assigned to one of three treatment groups: 1.2 mg JY09, 2.4 mg JY09, or dulaglutide, over a treatment period of 54 weeks followed by a safety follow-up. The goal is to determine which treatment provides better glycemic control and safety profiles for patients with T2DM.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with type 2 diabetes who have been on a stable dose of metformin and have an HbA1c level between 7.5% and 11.0%.

Not a fit: Patients who are not on metformin or have HbA1c levels outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with type 2 diabetes who struggle to achieve glycemic control with metformin alone.

How similar studies have performed: Previous studies have shown promising results with similar GLP-1 receptor agonists, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.
2. Those who meet the World Health Organization（WHO）1999 diagnostic criteria for type 2 diabetes mellitus and the WHO Recommendations for the Use of Glycosylated Haemoglobin (HbA1c) for Diagnosis (2011) supplemental diagnostic criteria for a diagnosis of T2DM for ≥ 12 weeks.
3. Received a stable dose of metformin monotherapy with a metformin dose ≥1500 mg/day or a maximally tolerated dose (\<1500 mg/day but ≥1000 mg/day) on the basis of dietary and exercise interventions during the 8 weeks prior to screening.
4. HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).
5. FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).
6. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V4).
7. Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.

Exclusion Criteria:

1. People diagnosed with type 1 diabetes or other types of diabetes.
2. Those who have used glucose-lowering drugs other than metformin within 8 weeks prior to screening or prior to randomization (V4), or those who have used drugs that may affect glucose metabolism, such as systemic glucocorticosteroids (except for inhalation or topical topical use) and growth hormone.
3. Those who have used glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon-like peptide-1 (GLP-1) receptor agonists (including single-target, multi-target agonists, and insulin-containing GLP-1 combinations) within 3 months prior to screening.
4. More than 14 days of continuous insulin use in the 6 months prior to screening.
5. Acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization .
6. Severe chronic complications of diabetes mellitus (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening, which are assessed by the investigator to be unsuitable for participation in this clinical study.
7. Individuals who have had severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or have undergone gastrointestinal surgery within 6 months prior to screening or prior to randomization or who have been using long-term medications for chronic gastrointestinal disease that have a direct effect on gastrointestinal motility are not suitable for participation in this clinical study, as assessed by the investigator.
8. Other conditions that, in the judgment of the investigator, make the subject unsuitable for participation in this clinical study.

Where this trial is running

Beijing, Beijing

• Peking University First Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Junqing Zhang, Doctor — Peking University First Hospital
• Study coordinator: Xuefeng Li, Master

Conditions Type2 Diabetes Mellitus; T2DM