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

Sponsor
Beijing Dongfang Biotech Co., Ltd.
Study ID
NCT06257966
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Exendin-4 Fc fusion protein injection(1.2mg） — DRUG
    1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
  • 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.
  • Dulaglutide — DRUG
    1.5 mg dulaglutide injection subcutaneously once a week for 54 weeks.
  • Metformin — DRUG
    Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Study Details

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)

Key Dates

Start date
Jul 17, 2024
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
600 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exendin-4 Fc fusion protein injection(1.2mg）+Metformin
    1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks.
  • Experimental: Exendin-4 Fc fusion protein injection(2.4mg）+Metformin
    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.
  • Active Comparator: Dulaglutide+Metformin
    1.5 mg dulaglutide injection subcutaneously once a week for 26 weeks.

Primary Outcome Measure

HbA1c [ Time Frame: Baseline, Week 26 ]

Related Studies