Clinical Trial Details
| Trial ID: | L4148 |
| Source ID: | NCT05950516 |
| Associated Drug: | Semaglutide |
| Title: | Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Semaglutide|DRUG: Semaglutide Pen Injector [Ozempic] |
| Outcome Measures: | Primary: Change in HbA1c, Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated, Week 33 | Secondary: Change in HbA1c, Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated, Week 21|Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%, Percentage of participants who achieved HbA1c \< 7.0%, HbA1c ≤6.5% is presented, Week 21, 33|Change in Fasting Glucose, Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated, Week 21, 33|Change in Body Weight, Change from baseline (week 1) to week 21, 33 in body weight was evaluated, Week 21, 33|Percentage of Participants That Achieved Body Weight Loss ≥5%, Percentage of participants losing ≥5% of baseline body weight is presented, Week 21, 33 |
| Sponsor/Collaborators: | Sponsor: Qilu 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: | 2023-07-10 |
| Completion Date: | 2025-01-22 |
| Results First Posted: | |
| Last Update Posted: | 2023-07-18 |
| Locations: | Shandong Provincial Hospital, Jinan, Shandong, China |
| URL: | https://clinicaltrials.gov/show/NCT05950516 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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