| Trial ID: | L3630 |
| Source ID: | NCT04390295
|
| Associated Drug: |
Placebo
|
| Title: |
Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Placebo|DRUG: SHR3824|DRUG: metformin
|
| Outcome Measures: |
Primary: Adjusted Mean Change in HbA1c Levels, Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group, Baseline to Week 24 | Secondary: Adjusted Mean Change in Fasting Plasma Glucose, Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group, Baseline to Week 24|The number of volunteers with adverse events as a measurement of safety, Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group, Baseline to Week 52
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
450
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-11-02
|
| Completion Date: |
2020-05
|
| Results First Posted: |
|
| Last Update Posted: |
2020-05-15
|
| Locations: |
Third Affiliated Hospital of Sun Yat - sen University, Guangzhou, Guangdong, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04390295
|
