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CompletedNCT05606913Updated Aug 23, 2024

A Study of IBI362 in Participants With Type 2 Diabetes

A Phase 3 interventional study of dulaglutide and IBI362 in Type 2 Diabetes, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
731
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 731 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
731 participants (actual)

Study arms

  • Experimental
    IBI362 6.0mg

    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks；③6mg, SC, once a week\* 20weeks.

    Drug: IBI362

  • Experimental
    dulaglutide

    1.5mg, SC, once a week\* 28weeks

    Drug: dulaglutide

  • Experimental
    IBI362 4.0mg

    2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 24weeks.

    Drug: IBI362

Interventions

  • Drugdulaglutide

    Dulaglutide administered subcutaneously (SC) once a week.

  • DrugIBI362

    IBI362 administered subcutaneously (SC) once a week.

06

What researchers measure

Primary outcomes

  1. HbA1c change from baseline at week 28

    Time frame: Baseline, 28 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • China-Japan Friendship Hospital
    Beijing, Beijin 100029, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05606913
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Nov 7, 2022
Start date
Jan 6, 2023
Primary completion
Jan 26, 2024
Completion
Apr 9, 2024
Last update
Aug 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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