Current partner codePEPTIDESDE
NCT04965506·Phase 2·INTERVENTIONAL

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Status

Completed

Phase

Phase 2

Enrollment

252

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

OTHER

placebo

placebo administered subcutaneously (SC) once a week.

OTHER

Dulaglutide

Dulaglutide administered subcutaneously (SC) once a week.

Timeline

From registration to results.

  1. First posted

    Jul 16, 2021

  2. Study start

    Sep 6, 2021

  3. Primary completion

    Apr 28, 2022

  4. Study completion

    Jun 11, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Dec 27, 2023

Outcomes

What the study measures.

Primary outcomes

The change in HbA1c from baseline to 20 weeks

Time frame · Baseline,20 weeks

Secondary outcomes

Percentage of Participants Achieving HbA1c Target of <7.0%

Time frame · Baseline,20 weeks

Number of participants with treatment-related adverse events

Time frame · Baseline,25 weeks

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Related trials

More studies on Mazdutide.

Related PeptideStat pages

Put the record in context.

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