A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965506
• Other study ID #: CIBI362A201
• Status: Completed
• Phase: Phase 2
• Start date: September 6, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: December 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: June 11, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• IBI362
IBI362 administered subcutaneously (SC) once a week.

Other:
• placebo
placebo administered subcutaneously (SC) once a week.
• Dulaglutide
Dulaglutide administered subcutaneously (SC) once a week.

Locations

Country	Name	City	State
China	China Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in HbA1c from baseline to 20 weeks		Baseline,20 weeks
Secondary	Percentage of Participants Achieving HbA1c Target of <7.0%		Baseline,20 weeks
Secondary	Number of participants with treatment-related adverse events		Baseline,25 weeks