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A Study of IBI362 in Chinese Patients With Type 2 Diabetes

NCT ID: NCT04965506

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2022-06-11

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IBI362 low dose

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

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 moderate dose

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

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

Dulaglutide

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

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type OTHER

Dulaglutide administered subcutaneously (SC) once a week.

IBI362 high dose

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

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo administered subcutaneously (SC) once a week.

Interventions

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IBI362

IBI362 administered subcutaneously (SC) once a week.

Intervention Type DRUG

placebo

placebo administered subcutaneously (SC) once a week.

Intervention Type OTHER

Dulaglutide

Dulaglutide administered subcutaneously (SC) once a week.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CIBI362A201

Identifier Type: -

Identifier Source: org_study_id