| Trial ID: | L5473 |
| Source ID: | NCT04504370
|
| Associated Drug: |
Glp-1 Receptor Agonist
|
| Title: |
Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
|
| Acronym: |
PB119
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: GLP-1 receptor agonist|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c, Change in HbA1c from baseline(week 1) to week 25, week 1, week 25 | Secondary: HbA1c Below 7.0%, Percentage of participants with HbA1c below 7.0% was evaluated at week 25., week 1, week 25|Change in Body Weight (kg), Change from baseline (week 1) in body weight was evaluated at week 25, week 1, week 25|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 1) in FPG was evaluated at week 25, week 1, week 25|Change in Body Mass Index, Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25., week 1, week 25
|
| Sponsor/Collaborators: |
Sponsor: PegBio Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
273
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-04-27
|
| Completion Date: |
2022-11-28
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-28
|
| Locations: |
Central South University The Second Xiangya Hospital, Changsha, Hunan, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04504370
|
