A Study of IBI362 in Chinese Patients With Type 2 Diabetes

December 24, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in HbA1c from baseline to 20 weeks
Time Frame: Baseline,20 weeks
Baseline,20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving HbA1c Target of <7.0%
Time Frame: Baseline,20 weeks
Baseline,20 weeks
Number of participants with treatment-related adverse events
Time Frame: Baseline,25 weeks
Baseline,25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

June 11, 2022

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI362A201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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