| Trial ID: | L3044 |
| Source ID: | NCT06263348
|
| Associated Drug: |
Dorzagliatin Tablets
|
| Title: |
A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2diabetes
|
| Interventions: |
DRUG: Dorzagliatin tablets
|
| Outcome Measures: |
Primary: Incidences of ADRs and SAEs, The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment., 52 weeks | Secondary: Blood glucose indicators, Changes from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and 2-hour postprandial plasma glucose (2h-PPG) after 52 weeks of treatment with Dorzagliatin, 52 weeks|Response rate, The proportion of patients with HbA1c \< 7% after 52 weeks of treatment, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hua Medicine Limited | Collaborators: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
2000
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-12-20
|
| Completion Date: |
2026-04-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-16
|
| Locations: |
China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|China-Japan Friendship Hospital, Beijing, Beijing, 100029, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06263348
|
