A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Dulaglutide; Drug: IBI362; Other: placebo

• Registration Number: NCT04965506
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Study Start: 2021-09-06
• Primary Completion: 2022-04-28
• Study Completion: 2022-06-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dulaglutide	Dulaglutide	Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.
IBI362 high dose	IBI362	Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.
placebo	placebo	Participants receive placebo by subcutaneous (SC) injection once a week.
IBI362 moderate dose	IBI362	Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.
IBI362 low dose	IBI362	Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.

Primary Outcome Measures

Name	Time	Method
The change in HbA1c from baseline to 20 weeks	Baseline,20 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China