A Study of IBI362 in Chinese Patients With Type 2 Diabetes

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04965506
• Collaborator: (none)
• Enrollment: 252
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 16.8
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: IBI362; Other: placebo; Other: Dulaglutide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 6, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI362 low dose Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Experimental: IBI362 moderate dose Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Active Comparator: Dulaglutide Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.	Other: Dulaglutide; Dulaglutide administered subcutaneously (SC) once a week.
Experimental: IBI362 high dose Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Placebo Comparator: placebo Participants receive placebo by subcutaneous (SC) injection once a week.	Other: placebo; placebo administered subcutaneously (SC) once a week.

Outcome Measures

Primary Outcome Measures

1. The change in HbA1c from baseline to 20 weeks [Baseline,20 weeks]

Secondary Outcome Measures

1. Percentage of Participants Achieving HbA1c Target of <7.0% [Baseline,20 weeks]

2. Number of participants with treatment-related adverse events [Baseline,25 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Japan Friendship Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04965506
• Other Study ID Numbers: CIBI362A201
• First Posted: Jul 16, 2021
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dulaglutide

Study Results

No Results Posted as of Jul 19, 2022