A Study of IBI362 in Chinese Patients With Type 2 Diabetes

A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04965506

Enrollment

252

Registered

2021-07-16

Start date

2021-09-06

Completion date

2022-06-11

Last updated

2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.

Interventions

DRUGIBI362

IBI362 administered subcutaneously (SC) once a week.

OTHERplacebo

placebo administered subcutaneously (SC) once a week.

OTHERDulaglutide

Dulaglutide administered subcutaneously (SC) once a week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999) 2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening. 3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening). 4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

Exclusion criteria

1. Type 1 diabetes, special types of diabetes, or gestational diabetes. 2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening. 3. History of severe hypoglycemic episodes within 6 months prior to screening. 4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.

Design outcomes

Primary

Measure	Time frame
The change in HbA1c from baseline to 20 weeks	Baseline,20 weeks

Secondary

Measure	Time frame
Percentage of Participants Achieving HbA1c Target of <7.0%	Baseline,20 weeks
Number of participants with treatment-related adverse events	Baseline,25 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026