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A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI362
placebo
Dulaglutide
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Japan Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

IBI362 low dose

IBI362 moderate dose

Dulaglutide

IBI362 high dose

placebo

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

The change in HbA1c from baseline to 20 weeks

Secondary Outcome Measures

Percentage of Participants Achieving HbA1c Target of <7.0%
Number of participants with treatment-related adverse events

Full Information

First Posted
July 15, 2021
Last Updated
July 15, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04965506
Brief Title
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI362 low dose
Arm Type
Experimental
Arm Description
Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.
Arm Title
IBI362 moderate dose
Arm Type
Experimental
Arm Description
Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.
Arm Title
Dulaglutide
Arm Type
Active Comparator
Arm Description
Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.
Arm Title
IBI362 high dose
Arm Type
Experimental
Arm Description
Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo by subcutaneous (SC) injection once a week.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
IBI362 administered subcutaneously (SC) once a week.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo administered subcutaneously (SC) once a week.
Intervention Type
Other
Intervention Name(s)
Dulaglutide
Intervention Description
Dulaglutide administered subcutaneously (SC) once a week.
Primary Outcome Measure Information:
Title
The change in HbA1c from baseline to 20 weeks
Time Frame
Baseline,20 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving HbA1c Target of <7.0%
Time Frame
Baseline,20 weeks
Title
Number of participants with treatment-related adverse events
Time Frame
Baseline,25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
China Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of IBI362 in Chinese Patients With Type 2 Diabetes

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