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Clinical Trials in China / NCT06257966
Active, not recruiting Phase 3

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

NCT06257966 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Dongfang Biotech Co., Ltd.
Phase
Phase 3
Started
2024-07-17
Last updated
2025-09-17

Condition(s) studied

Type2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Exendin-4 Fc fusion protein injection(1.2mg)Exendin-4 Fc fusion protein injection(2.4mg)DulaglutideMetformin

Exendin-4 Fc fusion protein injection(1.2mg): 1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.

Exendin-4 Fc fusion protein injection(2.4mg): The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks.

Dulaglutide: 1.5 mg dulaglutide injection subcutaneously once a week for 54 weeks.

Metformin: Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Study summary

The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality

On this site

📄 Trulicity (dulaglutide) drug profile → 📄 Glucophage (metformin) drug profile →

More Beijing Dongfang Biotech Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06257966 on ClinicalTrials.gov ↗ ← All trials in China