| Trial ID: | L3037 |
| Source ID: | NCT06059326
|
| Associated Drug: |
Hsk7653 10 Mg
|
| Title: |
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: HSK7653 10 mg|DRUG: HSK7653 25 mg|DRUG: HSK7653 50 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements., From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks | Secondary: Peak plasma concentration (Cmax) of HSK7653, Cmax of HSK7653 after first dose and multi-dose administration, Day 1 to Day 43|Area under the plasma concentration versus time curve (AUC) of HSK7653, AUC of HSK7653 after first dose and multi-dose administration, Day 1 to Day 43|Half-life (t1/2) of HSK7653, T1/2 of HSK7653 after single-dose and multi-dose administration, Day 1 to Day 43|Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate, Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653, Day 1 to Day 84|Change from baseline in GLP-1, Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653, Day 1 to Day 84|Change from baseline of fasting plasma glucose, Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653, Day 1 to Day 84|Change from baseline of HbA1c, Change from baseline in HbA1c after multi-dose administration of HSK7653, Day 1 to Day 84
|
| Sponsor/Collaborators: |
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-01-22
|
| Completion Date: |
2019-11-05
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-28
|
| Locations: |
Peking university people's hospital, Beijing, Beijing, 100044, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06059326
|
