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Type 2 DiabetesPhase 3NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

A Phase 3 study testing dulaglutide and IBI362 in people with Type 2 Diabetes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
dulaglutide and IBI362
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
1 siteChina
Study dates
6 Jan 2023to 9 Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • T2D was diagnosed according to WHO standards in 1999 for
  • Age ≥ 18 when signing the informed consent form
  • 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%.
  • BMI≥23 kg/m2 at screening.
  • Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Who cannot join

  • Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
  • Weight change>5% within 12 weeks before screening (chief complaint)
  • Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.
  • Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
  • 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)
  • 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
  • Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • China-Japan Friendship Hospital

    Beijing, Beijin, 100029

Other trials in China

About this study

Official title: Efficacy and Safety of IBI362 Versus Dulaglutide as add-on to Metformin and/or SGLT2 Inhibitor or TZD in Subjects With Type 2 Diabetes (DREAMS-2)

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.

Conditions
Type 2 Diabetes
Being tested
dulaglutide, IBI362
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dulaglutideDrug

    Dulaglutide administered subcutaneously (SC) once a week.

  • IBI362Drug

    IBI362 administered subcutaneously (SC) once a week.

Study groups in NCT05606913
Study groupRoleWhat they receive
IBI362 6.0mgExperimental①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks；③6mg, SC, once a week* 20weeks.
Receives: Drug: IBI362
dulaglutideExperimental1.5mg, SC, once a week* 28weeks
Receives: Drug: dulaglutide
IBI362 4.0mgExperimental2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 24weeks.
Receives: Drug: IBI362

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c change from baseline at week 28

    Measured: Baseline, 28 weeks

Secondary outcomes (13)

  1. percent change from baseline in body weigh

    Measured: Baseline, 28 weeks

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

    Measured: Baseline, 28 weeks

  3. Change from baseline in HbA1c (superiority)

    Measured: Baseline, 28 weeks

  4. Proportion of subjects with HbA1c <7.0%

    Measured: Baseline, 28 weeks

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

    Measured: Baseline to 32weeks

  6. Time to peak plasma concentration (Tmax)

    Measured: Baseline to 28weeks

  7. Time to peak plasma concentration (Cmax)

    Measured: Baseline to 28weeks

  8. area under curve (AUC)

    Measured: Baseline to 28weeks

  9. volume distribution (V)

    Measured: Baseline to 28weeks

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

    Measured: Baseline to 28weeks

  11. clearance rate (clearance, CL)

    Measured: Baseline to 28weeks

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

    Measured: Baseline to 28weeks

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

    Measured: Baseline to 28weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start6 Jan 2023
  3. Primary completion26 Jan 2024
  4. Study completion9 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606913
Sponsor's protocol ID
CIBI362A302
Status last verified
Aug 2024
First submitted
19 Oct 2022
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo L, Zhang B, Xue X, Zhang X, Cai H, Jiang H, Zhang L, Jin P, Wang X, Cheng Z, Zhang S, Geng J, Guo Y, Hu H, Ma Q, Li L, Du H, Han-Zhang H, Xue F, Deng H, Qian L, Yang W; DREAMS-2 investigators. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):181-188. doi: 10.1038/s41586-025-10031-z. Epub 2025 Dec 17.

    PubMed 41407860

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dulaglutide and IBI362 in people with Type 2 Diabetes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c change from baseline at week 28 (time frame: Baseline, 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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