| Trial ID: | L1933 |
| Source ID: | NCT03173391
|
| Associated Drug: |
Hms5552
|
| Title: |
Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: HMS5552|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment, 24 weeks | Secondary: The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline, The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment, 24 weeks|The change of fasting plasma glucose (FPG) from baseline, The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment, 24 weeks|The proportion of subjects with HbA1c < 7.0%, The HbA1c response rate in T2DM subjects after 24-week double-blind treatment, 24 weeks|Incidence of Treatment-Emergent Adverse Events over time, including incidence of adverse events, incidence of hypoglycemic events, physical examination, vital signs, 12-lead ECG, clinical laboratory examinations (routine blood test, blood biochemistry and routine urine test)., 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hua Medicine Limited | Collaborators: Tigermed Consulting Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
463
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-07-18
|
| Completion Date: |
2020-11-30
|
| Results First Posted: |
|
| Last Update Posted: |
2021-08-26
|
| Locations: |
Hua Medicine Limited, Shanghai, Shanghai, 201203, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03173391
|
