| Trial ID: | L7355 |
| Source ID: | NCT06818851
|
| Associated Drug: |
Henggliflozin
|
| Title: |
The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
|
| Acronym: |
HOLIDYA
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Henggliflozin|OTHER: Placebo
|
| Outcome Measures: |
Primary: Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks, From enrollment to the end of treatment at 16 weeks | Secondary: Change from Baseline in the immunophenotype of peripheral blood mononuclear cells at 16 weeks, From enrollment to the end of treatment at 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2025-04-01
|
| Completion Date: |
2028-03-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-11
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06818851
|
