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

NCT06257966 | Active Not Recruiting Phase 3

• 1 other identifier: DFBT-JY09-DM-302
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Type2 Diabetes Mellitus

Keywords

T2DM

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  Baseline, Week 26

Secondary Outcomes (7)

• The proportion of HbA1c <6.5% and <7%

  Baseline, Week 26,Week 54

• HbA1c

  Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

• fasting plasma glucose (FPG)

  Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

• fasting insulin

  Baseline, Week 14,Week 26,Week 54

• Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)

  Baseline,Week 26,Week 54

Study Arms (3)

Exendin-4 Fc fusion protein injection(1.2mg）+Metformin

EXPERIMENTAL

1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks.

Drug: Exendin-4 Fc fusion protein injection(1.2mg）; Drug: Metformin

Exendin-4 Fc fusion protein injection(2.4mg）+Metformin

EXPERIMENTAL

The first dose of 1.2 mg of JY09 injection was administered, the dose was adjusted to 2.4 mg after two weeks, after which 2.4 mg was maintained to continue subcutaneous injection in the abdomen, bi-weekly treatment for 52 weeks.

Drug: Exendin-4 Fc fusion protein injection（2.4mg）; Drug: Metformin

Dulaglutide+Metformin

ACTIVE COMPARATOR

1.5 mg dulaglutide injection subcutaneously once a week for 26 weeks.

Drug: Dulaglutide; Drug: Metformin

Interventions

Exendin-4 Fc fusion protein injection(1.2mg） DRUG

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

Also known as: JY09(1.2mg)

Exendin-4 Fc fusion protein injection(1.2mg）+Metformin

Exendin-4 Fc fusion protein injection（2.4mg） DRUG

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.

Also known as: JY09(2.4mg)

Exendin-4 Fc fusion protein injection(2.4mg）+Metformin

Dulaglutide DRUG

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

Dulaglutide+Metformin

Metformin DRUG

Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Dulaglutide+Metformin; Exendin-4 Fc fusion protein injection(1.2mg）+Metformin; Exendin-4 Fc fusion protein injection(2.4mg）+Metformin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.
• 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.
• 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.
• HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).
• FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).
• 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.

You may not qualify if:

• People diagnosed with type 1 diabetes or other types of diabetes.
• 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.
• 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.
• 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 .
• 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.
• 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.
• Other conditions that, in the judgment of the investigator, make the subject unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Beijing Dongfang Biotech Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

dulaglutide; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Junqing Zhang, Doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized in a 1:1:1 ratio to the 1.2 mg JY09 injection group (n=200 cases), the 2.4 mg JY09 injection group (n=200 cases), and the dulaglutide injection group (n=200 cases).

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)