| Trial ID: | L3294 |
| Source ID: | NCT06767735
|
| Associated Drug: |
Gzr4
|
| Title: |
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects with Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: GZR4|DRUG: Insulin Glargine U100
|
| Outcome Measures: |
Primary: Change in HbA1c, From baseline (week 0) to week 26 | Secondary: Change in HbA1c, From baseline (week 0) to week 52|hypoglycaemia events, From baseline (week 0) to week 26/52|adverse events, From baseline (week 0) to week 26/52|Change in weight, From baseline (week 0) to week 26
|
| Sponsor/Collaborators: |
Sponsor: Gan & Lee Pharmaceuticals.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
580
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-02-14
|
| Completion Date: |
2026-08-17
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-10
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06767735
|
