| Trial ID: | L4846 |
| Source ID: | NCT06688123
|
| Associated Drug: |
Shr-3167
|
| Title: |
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: SHR-3167|DRUG: SHR-3167|DRUG: Insulin glargine
|
| Outcome Measures: |
Primary: Change from baseline to week 20 in HbA1c (HemoglobinA1c), Change from baseline in HbA1c after 20 weeks of treatment., Week 0 to week 20. | Secondary: Percentage of participants achieving HbA1c<7.0%, Week 0 to week 20.|Change from baseline to week 20 in fasting plasma glucose (FPG), Week 0 to week 20.|Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast, Week 0 to week 20.|Number of adverse events (AEs) during the trial, Week 0 to week 24.
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
273
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01-08
|
| Completion Date: |
2025-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-21
|
| Locations: |
Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 210029, China|Shanghai Sixth People's Hospital, Shanghai, Shanghai, 200233, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06688123
|
