The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
211
Subcutaneous Injection
Subcutaneous Injection with matched volume
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Change from baseline in HbA1c
Time frame: Baseline, Week 24
Change from baseline in HbA1c
Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment
Time frame: week 24, week 52
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain
Time frame: week 24
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Week 24 and Week 52
Change from baseline in fasting insulin
Time frame: Baseline, Week 24 and Week 52
Change from baseline in lipid panel
Time frame: Baseline, Week 24 and Week 52
Change from baseline in 2-hour postprandial blood glucose
Time frame: Baseline, Week 24 and Week 52
Change from baseline in 7-point self-monitored blood glucose
Time frame: Baseline, Week 24 and Week 52
Change from baseline in HOMA-IR
Time frame: Baseline, Week 24 and Week 52
Change from baseline in HOMA-β
Time frame: Baseline, Week 24 and Week 52
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Change from baseline in body weight
Time frame: Baseline, Week 24 and Week 52
Change from baseline in waist circumference
Time frame: Baseline, Week 24 and Week 52
Change from baseline in hip circumference
Time frame: Baseline, Week 24 and Week 52