Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04466904
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IBI362 — DRUG
    Administrated by subcutaneous injection
  • Placebo — DRUG
    Administrated by subcutaneous injection
  • Dulaglutide — DRUG
    Administrated by subcutaneous injection

Study Details

This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention

Key Dates

Start date
Sep 12, 2020
Status verified
Jul 2021
Primary completion
May 28, 2021
Completion
May 28, 2021

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI362 low dose cohort
    Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
  • Experimental: IBI362 medium dose cohort
    Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
  • Experimental: IBI362 high dose cohort
    Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection

Primary Outcome Measure

To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo [ Time Frame: From the first dose of study drug to week 19 ]

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