A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04965506
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.

Key Dates

Start date
Sep 6, 2021
Status verified
Dec 2023
Primary completion
Apr 28, 2022
Completion
Jun 11, 2022

Study Design

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

Arms

  • Experimental: IBI362 low dose
    Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.
  • Experimental: IBI362 moderate dose
    Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.
  • Active Comparator: Dulaglutide
    Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.
  • Experimental: IBI362 high dose
    Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.
  • Placebo Comparator: placebo
    Participants receive placebo by subcutaneous (SC) injection once a week.

Primary Outcome Measure

The change in HbA1c from baseline to 20 weeks [ Time Frame: Baseline,20 weeks ]

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