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CompletedPhase 3

A Study of IBI362 in Participants With Type 2 Diabetes

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)

Assets

Dulaglutide / Mazdutide

Listed sites

1

Recruiting sites

Enrollment

731

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥23HbA1c ≤11%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05606913
Org study IDCIBI362A302

Timeline

Milestones

Study first posted2022-11-07actual
Study start2023-01-06actual
Primary completion2024-01-26actual
Study completion2024-04-09actual
Last update posted2024-08-23actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
7
Glycemic / diabetes
6
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

percent change from baseline in body weigh

Time frame:Baseline, 28 weeks

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

HbA1c change from baseline at week 28

Time frame:Baseline, 28 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 28 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in HbA1c (superiority)

Time frame:Baseline, 28 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects with HbA1c <7.0%

Time frame:Baseline, 28 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Baseline to 28weeks

change from baseline, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline to 28weeks

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline to 32weeks

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Time to peak plasma concentration (Tmax)

Time frame:Baseline to 28weeks

Tmax

descriptive

Secondary/protocol endpoint

Time to peak plasma concentration (Cmax)

Time frame:Baseline to 28weeks

Tmax

descriptive

Secondary/protocol endpoint

area under curve (AUC)

Time frame:Baseline to 28weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

volume distribution (V)

Time frame:Baseline to 28weeks

descriptive

Secondary/protocol endpoint

half-life (half-life, T1/2

Time frame:Baseline to 28weeks

Half-life

descriptive

Secondary/protocol endpoint

clearance rate (clearance, CL)

Time frame:Baseline to 28weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.