A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
T2DM, Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for T2DM focused on measuring T2DM, Glucagon-like peptide-1, GLP-1, Ecnoglutide, XW003
Eligibility Criteria
Inclusion Criteria: Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures Sex: male or female; Age: 18 to 75 years, inclusive BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening. HbA1c ranging from 7.5% to 11.0% at screening, inclusive FPG ≤13.9 mmol/L at screening Exclusion Criteria: History of type 1 or other types of diabetes mellitus Use of insulin during the 6 months preceding screening History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening. History of acute or chronic pancreatitis or high-risk factors for pancreatitis Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
Sites / Locations
- ZHONGSHAN Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
B1: XW003+MET
B2: XW003+MET
B3: Dulaglutide+MET
High dosage of XW003 once weekly
Low dosage of XW003 once weekly
1.5mg Dulaglutide once weekly