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Clinical Trial Details

Trial ID: L3244
Source ID: NCT06339086
Associated Drug: Semaglutide Injection
Title: Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Semaglutide Injection|DRUG: Semaglutide Injection(Ozempic®)|DRUG: Metformin
Outcome Measures: Primary: Change in HbA1c, Change from baseline to week 32 in Glycosylated Hemoglobin(HbA1c)., Week 32 | Secondary: Change in HbA1c, Change from baseline to week 20 in HbA1c., Week 20|Change in FPG, Change from baseline to week 20, 32 in Fasting Plasma Glucose(FPG)., Week 20,32|Proportion of participants who achieved HbA1c<7.0%,HbA1c≤6.5%, Proportion of participants who achieved HbA1c\<7.0%,HbA1c≤6.5% at week 20, 32., Week 20,32|Proportion of participants who achieved HbA1c<7.0%,HbA1c≤6.5% with no hypoglycemic event, Proportion of participants who achieved HbA1c\<7.0%,HbA1c≤6.5% with no confirmed symptomatic hypoglycemic event reported after treatment., Week 20,32|Change in Body Weight, Change from baseline to week 20, 32 in Body Weight., Week 20,32|Proportion of participants with Weight Loss≥5%, ≥10% and ≥15%, Proportion of participants with Weight Loss≥5%, ≥10% and ≥15% at week 20, 32., Week 20,32|Change in Diastolic and Systolic Blood Pressure, Change from baseline to week 32 in Diastolic and Systolic Blood Pressure., Week 32|Changes in Blood Lipids, Changes baseline to week 32 in Blood Lipids: Total Cholesterol, Low-density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol, and Triglycerides., Week 32|Incidence and severity of Adverse Events, Incidence and severity of Adverse Events during treatment., Week 32
Sponsor/Collaborators: Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 478
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04
Completion Date: 2025-12-30
Results First Posted:
Last Update Posted: 2024-04-01
Locations:
URL: https://clinicaltrials.gov/show/NCT06339086