A Study of IBI362 in Chinese Patients With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Dulaglutide

Criteria

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.