A Phase 3 interventional study of semaglutide injection in Diabetes Mellitus, Type 2, sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,. Completed at 35 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Hangzhou Jiuyuan Gene Engineering Co. Ltd., · Phase 3, Interventional, and Treatment
Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China. The purpose of this study is to investigate the similarities in the efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2 diabetes, respectively.
This study is a multicenter, randomized, open-label, parallel assignment, which plans to enroll 476 patients with type 2 diabetes And Stable daily dose for 4 weeks prior to the day of screening of the metformin formulations (greater than or equal to 1500 mg to less than or equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg. The study was divided into three phases: screening, baseline and treatment.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 476 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hangzhou Jiuyuan Gene Engineering Co. Ltd., is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Semaglutide 0.25 mg、0.5 mg、1.0mg
Biological: semaglutide injection
Ozempic® 0.25 mg、0.5 mg、1.0mg
Biological: semaglutide injection
The subject will receive either a dose semaglutide once weekly (subcutaneous (s.c.) injection). The initial dose of 0.25 mg is s.c. once weekly, and the dose is increased to 0.5 mg after 4 weeks of administration, and the dose is increased to 1 mg after 4 weeks of 0.5 mg administration, and the dose is continued at a stable dose of 1 mg for 24 weeks.Treatment duration 32 weeks.
The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment.
Time frame: 32 weeks
The observed mean change in HbA1c values from baseline after 20 weeks of treatment.
Time frame: 20 weeks
Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG).
Time frame: 20 weeks
Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG).
Time frame: 32 weeks
Change From Baseline to Week 32 in HbA1c < 7.0% of participants.
Time frame: 32 weeks
Change From Baseline to Week 32 in HbA1c≤6.5% of participants.
Time frame: 32 weeks
Change From Baseline to Week 32 in HbA1c < 7.0% of participants with no hypoglycemic events.
Time frame: 32 weeks
Change From Baseline to Week 32 in Body Weight (Kilogram (kg)).
Time frame: 32 weeks
Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure.
Time frame: 32 weeks
Change From Baseline to Week 32 in Pulse Rate.
Time frame: 32 weeks
Change From Baseline to Week 32 in Fasting Blood Lipids: Total Cholesterol、Low-density Lipoprotein (LDL) Cholesterol、 High-density Lipoprotein (HDL) Cholesterol 、Triglycerides (Ratio to Baseline).
Time frame: 32weeks
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Hangzhou Jiuyuan Gene Engineering Co. Ltd.,