| Trial ID: | L5483 |
| Source ID: | NCT02346175
|
| Associated Drug: |
Shr3824
|
| Title: |
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: SHR3824|DRUG: Placebo
|
| Outcome Measures: |
Primary: Plasma pharmacokinetic parameters of SHR3824, up to Day 13|Urine glucose concentration of SHR3824, up to Day 11|Plasma glucose concentration of SHR3824, up to Day 11 | Secondary: The number and type of adverse events reported, Up to Day 13
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-03
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02346175
|
