| Trial ID: | L7324 |
| Source ID: | NCT02366351
|
| Associated Drug: |
Shr3824
|
| Title: |
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: SHR3824|DRUG: Placebo
|
| Outcome Measures: |
Primary: Adjusted Mean Change in HbA1c Levels, Baseline to Week 12|The number of volunteers with adverse events as a measure of safety and tolerability, Baseline to Week 12 | Secondary: Adjusted Mean Change in Fasting Plasma Glucose, Baseline to Week 12|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%, Baseline to Week 12
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
168
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-02
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-19
|
| Locations: |
Chinese PLA General Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02366351
|
