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A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin
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
Lead sponsor
Assets
Dulaglutide / Exenatide
Listed sites
1
Recruiting sites
—
Enrollment
600
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI 18.5-35
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
6 endpointsHbA1c
Time frame:Baseline, Week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The proportion of HbA1c <6.5% and <7%
Time frame:Baseline, Week 26,Week 54
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
HbA1c
Time frame:Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
HbA1c, change
change from baseline, improvement
LOINC 4548-4
fasting plasma glucose (FPG)
Time frame:Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
fasting insulin
Time frame:Baseline, Week 14,Week 26,Week 54
change from baseline, improvement
Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)
Time frame:Baseline,Week 26,Week 54
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Cardiometabolic biomarkers
1 endpointblood pressure
Time frame:Baseline,Week 26,Week 54
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Patient-reported / QoL
1 endpointHealth Survey Short Form (SF-36)
Time frame:Baseline,Week 26,Week 54
SF-36 total
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.