| Trial ID: | L6850 |
| Source ID: | NCT03848793
|
| Associated Drug: |
Hs-20004
|
| Title: |
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: HS-20004
|
| Outcome Measures: |
Primary: HbA1c, Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product, 16 weeks treatment | Secondary: Change in Fasting Plasma Glucose, Estimated mean change from baseline in FPG at week 16., 16 weeks treatment|Change in Body Weight, Estimated mean change from baseline in Body Weigh at week 16., 16 weeks treatment
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
128
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-03-06
|
| Completion Date: |
2020-12-14
|
| Results First Posted: |
|
| Last Update Posted: |
2022-11-07
|
| Locations: |
Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03848793
|
