A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Study Overview
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: IBI362
* Other: placebo
* Other: Dulaglutide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI362 low dose<br>Participants receive low dose IBI362 by subcutaneous (SC) injection once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 moderate dose<br>Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Active Comparator: Dulaglutide<br>Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week. | Other: Dulaglutide<br>* Dulaglutide administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 high dose<br>Participants receive high dose IBI362 by subcutaneous (SC) injection once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Placebo Comparator: placebo<br>Participants receive placebo by subcutaneous (SC) injection once a week. | Other: placebo<br>* placebo administered subcutaneously (SC) once a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in HbA1c from baseline to 20 weeks |  | Baseline,20 weeks | 

Secondary Outcome Measures

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