| Trial ID: | L5084 |
| Source ID: | NCT05326490
|
| Associated Drug: |
Pb-201
|
| Title: |
Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: PB-201|DRUG: PB-201 matched placebo|DRUG: Metformin hydrochloride
|
| Outcome Measures: |
Primary: Change in HbA1c, Change of glycosylated hemoglobin (HbA1c) from baseline to 24 weeks after treatment, Week 1,Week 25 |
|
| Sponsor/Collaborators: |
Sponsor: PegBio Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
546
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-30
|
| Completion Date: |
2024-10-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-22
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05326490
|
