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Trial · Interventional

CompletedPhase 3Registry data

A Study of IBI362 in Participants With Type 2 Diabetes

NCTNCT05606913 (opens ClinicalTrials.gov in a new tab)Other idCIBI362A302
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
731 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
6 Jan 2023
Primary completion
26 Jan 2024
Completion
9 Apr 2024
First posted
7 Nov 2022
Last update posted
23 Aug 2024
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 3

    A Study of IBI362 in Participants With Type 2 Diabetes

    NCT05606913

    6 Jan 2023 to 9 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • dulaglutideDrug
  • IBI362Drug

Arms3

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c change from baseline at week 28

    Time frame · Baseline, 28 weeks

Secondary outcomes(13)

  1. percent change from baseline in body weigh

    Time frame · Baseline, 28 weeks

  2. Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline

    Time frame · Baseline, 28 weeks

  3. Change from baseline in HbA1c (superiority)

    Time frame · Baseline, 28 weeks

  4. Proportion of subjects with HbA1c <7.0%

    Time frame · Baseline, 28 weeks

  5. Safety,Incidence and severity of adverse events and correlation with study drug;

    Time frame · Baseline to 32weeks

  6. Time to peak plasma concentration (Tmax)

    Time frame · Baseline to 28weeks

  7. Time to peak plasma concentration (Cmax)

    Time frame · Baseline to 28weeks

  8. area under curve (AUC)

    Time frame · Baseline to 28weeks

  9. volume distribution (V)

    Time frame · Baseline to 28weeks

  10. half-life (half-life, T1/2

    Time frame · Baseline to 28weeks

  11. clearance rate (clearance, CL)

    Time frame · Baseline to 28weeks

  12. To assess changes in PD parameters fasting insulin at different time points before and after administration.

    Time frame · Baseline to 28weeks

  13. To assess changes in PD parameters fasting C-peptide at different time points before and after administration.

    Time frame · Baseline to 28weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

16 results

Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.

Guo et al. 2026Naturecited by 13

PMID 41407860DOI 10.1038/s41586-025-10031-zPUB-41407860

Full text at the publisher16 results
Publisher pageSee results (16)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. T2D was diagnosed according to WHO standards in 1999 for 2. Age ≥ 18 when signing the informed consent form 3. After used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%. 4. BMI≥23 kg/m2 at screening. 5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol Exclusion Criteria: 1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. Weight change\>5% within 12 weeks before screening (chief complaint) 3. Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening. 4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes 5. There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period 8. The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study

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