| Trial ID: | L4493 |
| Source ID: | NCT03604419
|
| Associated Drug: |
Pb-119 100 Μg+ Glucophage®
|
| Title: |
Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: PB-119 100 μg+ Glucophage®|DRUG: PB-119 150 μg+ Glucophage®|DRUG: PB-119 200 μg+ Glucophage®|DRUG: PB-119 placebo + Glucophage®
|
| Outcome Measures: |
Primary: The change from baseline value of HbA1c will be compared between treatments, From Baseline to end of treatment (up to Week 12) | Secondary: The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12, From Baseline to end of treatment (up to Week 12)
|
| Sponsor/Collaborators: |
Sponsor: PegBio Co., Ltd. | Collaborators: Covance
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
214
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-06-13
|
| Completion Date: |
2019-07-23
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-22
|
| Locations: |
Clinical Pharmacology of Miami, Miami, Florida, 33014, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03604419
|
