| Trial ID: | L1827 |
| Source ID: | NCT06393348
|
| Associated Drug: |
Hrs-7535
|
| Title: |
Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS-7535|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline at Week 16, Week 16 | Secondary: Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks, 16 weeks|Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks, 16 weeks|The change in fasting blood glucose from baseline to 16 weeks, 16 weeks|The change in in body weight from baseline to 16 weeks, 16 weeks|The change in 7-point SMBG profile from baseline to 16 weeks, 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2024-06
|
| Completion Date: |
2025-11
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-01
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06393348
|
