| Trial ID: | L4389 |
| Source ID: | NCT06148649
|
| Associated Drug: |
Hec88473, Placebo, Dulaglutide
|
| Title: |
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HEC88473, Placebo, Dulaglutide
|
| Outcome Measures: |
Primary: Change from baseline of HbA1c at week 12, HbA1c, Baseline to week 12 | Secondary: Change from baseline of weight at week 12, weight, Baseline to week 12|Change from baseline of fasting blood-glucose at week 12, fasting blood-glucose, Baseline to week 12|Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events (AEs) and Serious Adverse Events (SAEs), Baseline to week 15
|
| Sponsor/Collaborators: |
Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
225
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-10
|
| Completion Date: |
2024-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-28
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, 100044, China|Shijiazhuang People's Hospital, Shijiazhuang, Hebei, 050000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06148649
|
