A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Other: placebo; Other: Dulaglutide; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT04965506

CIBI362A201

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 5 patient groups, including a placebo group

IBI362 low dose

Experimental group

Description:

Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.

Treatment:

Drug: IBI362

IBI362 moderate dose

Experimental group

Description:

Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.

Treatment:

Drug: IBI362

Dulaglutide

Active Comparator group

Description:

Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.

Treatment:

Other: Dulaglutide

IBI362 high dose

Experimental group

Description:

Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.

Treatment:

Drug: IBI362

placebo

Placebo Comparator group

Description:

Participants receive placebo by subcutaneous (SC) injection once a week.

Treatment:

Other: placebo