A Study of IBI362 in Participants With Type 2 Diabetes

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05606913
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dulaglutide — DRUG
    Dulaglutide administered subcutaneously (SC) once a week.
  • IBI362 — DRUG
    IBI362 administered subcutaneously (SC) once a week.

Study Details

This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.

Key Dates

Start date
Jan 6, 2023
Status verified
Aug 2024
Primary completion
Jan 26, 2024
Completion
Apr 9, 2024

Study Design

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

Arms

  • Experimental: IBI362 6.0mg
    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks；③6mg, SC, once a week\* 20weeks.
  • Experimental: dulaglutide
    1.5mg, SC, once a week\* 28weeks
  • Experimental: IBI362 4.0mg
    2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 24weeks.

Primary Outcome Measure

HbA1c change from baseline at week 28 [ Time Frame: Baseline, 28 weeks ]

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