DRUG
IBI362
IBI362 administered subcutaneously (SC) once a week.
Status
Completed
Phase
Phase 2
Enrollment
252
Locations
1
Results
Not posted
Publications
1
Study summary
The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.
Interventions
DRUG
IBI362 administered subcutaneously (SC) once a week.
OTHER
placebo administered subcutaneously (SC) once a week.
OTHER
Dulaglutide administered subcutaneously (SC) once a week.
Timeline
First posted
Jul 16, 2021
Study start
Sep 6, 2021
Primary completion
Apr 28, 2022
Study completion
Jun 11, 2022
Results posted
Not reported
Registry updated
Dec 27, 2023
Outcomes
The change in HbA1c from baseline to 20 weeks
Time frame · Baseline,20 weeks
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
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
China. Showing up to 24 locations stored in the fast local snapshot.
China Japan Friendship Hospital
Beijing, Beijing Municipality, China
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