| Trial ID: | L5607 |
| Source ID: | NCT03973515
|
| Associated Drug: |
Glucokinase Activator
|
| Title: |
Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes Mellitus
|
| Interventions: |
DRUG: glucokinase activator|DRUG: Placebo
|
| Outcome Measures: |
Primary: Time to peak(Tmax), hour, 9 days|Peak Plasma Concentration (Cmax), ng/mL, 9 days|Area under the plasma concentration versus time curve (AUC), ng•hr/mL, 9 days | Secondary: The change for fasting plasma glucose (FPG), The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo, 8days|The change for postprandial plasma glucose (PPG), The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo, 8 days|The change for plasma C-peptide, The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo, 8 days|The change for plasma insulin, The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo, 8 days
|
| Sponsor/Collaborators: |
Sponsor: PegBio Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-27
|
| Completion Date: |
2019-12-19
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-22
|
| Locations: |
Peking University Third Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03973515
|
