| Trial ID: | L2692 |
| Source ID: | NCT06161844
|
| Associated Drug: |
Semaglutide Injection (Hd1916)
|
| Title: |
Efficacy and Safety of Semaglutide Injection (HD1916) in Patients with Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: semaglutide injection (HD1916)|DRUG: Ozempic®
|
| Outcome Measures: |
Primary: Change from baseline to week 32 in glycosylated haemoglobin (HbA1c), Week 32 | Secondary: Change from baseline to week 20 in HbA1c, Week 20|Change from baseline to week 20, 32 in fasting blood glucose, Week 20 and 32|Percentage of participants who achieved HbA1c < 7.0% and HbA1c ≤6.5% at week 20 or week 32, Week 20 and 32|Change from baseline to week 20, 32 in body weight, Week 20 and 32|Change from baseline to week 20, 32 in postprandial blood glucose, Week 20 and 32|Percentage of participants who were offered rescue medication at week 20, Week 32|Incidence and severity of adverse events, Week 35|Occurence of anti-semaglutide antibodies and neutralizing antibody, Week 35|Blood concentration of semaglutide, Week 35
|
| Sponsor/Collaborators: |
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
506
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-23
|
| Completion Date: |
2026-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-10
|
| Locations: |
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong, Guangdong, 510235, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06161844
|
