Current partner codePEPTIDESDE
NCT06257966·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

600

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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)

Full detailed description

This study was designed as a multicenter, randomized, open, parallel, positively controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus who have poor glycemic control after metformin treatment only. The proposed plan is to enroll 600 subjects with T2DM, using stratified block group randomization with the stratification factor being baseline HbA1c (≤8.5% or \>8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=200 subjects), 2.4 mg JY09 injection group (n=200 subjects) and dulaglutide injection group (n=200 subjects) in a 1:1:1 ratio. The trial was divided into 4 phases, i.e., a screening period of 2 weeks, an introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. A total of 64 weeks.

Interventions

Treatment arms and agents.

DRUG

Exendin-4 Fc fusion protein injection(1.2mg)

1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.

DRUG

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.

DRUG

Dulaglutide

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

DRUG

Metformin

Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Timeline

From registration to results.

  1. First posted

    Feb 14, 2024

  2. Study start

    Jul 17, 2024

  3. Primary completion

    Oct 1, 2026

  4. Study completion

    Nov 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Sep 17, 2025

Outcomes

What the study measures.

Primary outcomes

HbA1c

Time frame · Baseline, Week 26

Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment

Secondary outcomes

The proportion of HbA1c <6.5% and <7%

Time frame · Baseline, Week 26,Week 54

Proportion of subjects with HbA1c \<7% and HbA1c \<6.5% after 26 and 54 weeks of treatment

HbA1c

Time frame · Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

Change in HbA1c relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.

fasting plasma glucose (FPG)

Time frame · Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

Change in fasting plasma glucose (FPG) relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.

fasting insulin

Time frame · Baseline, Week 14,Week 26,Week 54

Change in fasting insulin relative to baseline after 14, 26, and 54 weeks of treatment.

Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)

Time frame · Baseline,Week 26,Week 54

Change in HOMA-IR relative to baseline after 26 and 54 weeks of treatment.

Health Survey Short Form (SF-36)

Time frame · Baseline,Week 26,Week 54

Value of change in Health Survey Short Form (SF-36) scores relative to baseline after 26 and 54 weeks of treatment.

blood pressure

Time frame · Baseline,Week 26,Week 54

Change in blood pressure (sitting) relative to baseline after 26 and 54 weeks of treatment. The blood pressure includes systolic and diastolic blood pressure.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University First Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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