A Study of IBI362 in Chinese Patients With Type 2 Diabetes

NCT04965506 | Completed Phase 2

• 1 other identifier: CIBI362A201
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The change in HbA1c from baseline to 20 weeks

  Baseline,20 weeks

Secondary Outcomes (2)

• Percentage of Participants Achieving HbA1c Target of <7.0%

  Baseline,20 weeks

• Number of participants with treatment-related adverse events

  Baseline,25 weeks

Study Arms (5)

IBI362 low dose

EXPERIMENTAL

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

Drug: IBI362

IBI362 moderate dose

EXPERIMENTAL

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

Drug: IBI362

Dulaglutide

ACTIVE COMPARATOR

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

Other: Dulaglutide

IBI362 high dose

EXPERIMENTAL

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

Drug: IBI362

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

IBI362 DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 high dose; IBI362 low dose; IBI362 moderate dose

placebo OTHER

placebo administered subcutaneously (SC) once a week.

placebo

Dulaglutide OTHER

Dulaglutide administered subcutaneously (SC) once a week.

Dulaglutide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
• 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.
• Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
• Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

You may not qualify if:

• Type 1 diabetes, special types of diabetes, or gestational diabetes.
• Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
• History of severe hypoglycemic episodes within 6 months prior to screening.
• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mazdutide; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 16, 2021
• Study Start: September 6, 2021
• Primary Completion: April 28, 2022
• Study Completion: June 11, 2022
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)