| Trial ID: | L2181 |
| Source ID: | NCT06649773
|
| Associated Drug: |
Noiiglutide Injection
|
| Title: |
The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Noiiglutide Injection|DRUG: Noiiglutide Placebo
|
| Outcome Measures: |
Primary: Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo., Week 24 | Secondary: The proportion of subjects who achieve the HbA1c target value (<7.0%), Week 24|The proportion of subjects who achieve the HbA1c target value (≤ 6.5%), Week 24|Changes in fasting plasma glucose relative to baseline, Week 24|Changes in fasting body weight relative to baseline, Week 24|Changes in plasma glucose levels relative to baseline 2 hours after meals, Week 24|7-point self-test of blood glucose (SMBG) spectrum relative to baseline changes, Week 24|Changes in blood pressure relative to baseline, Week 24|Changes in fasting insulin relative to baseline, Week 24|Changes in C-peptide relative to baseline, Week 24|Changes in insulin levels relative to baseline 2 hours after meals, Week 24|Changes in C-peptide levels relative to baseline 2 hours after meals, Week 24|Adverse events (AE), Week 24|ADA of SHR20004, Week 24|Nab of SHR20004, Week 24|The concentration of SHR20004 in plasma at steady state, Week 24
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
124
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-25
|
| Completion Date: |
2025-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-14
|
| Locations: |
Beijing Chaoyang Hospital Affiliated to Capital, Beijing, Beijing, 100020, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06649773
|
