The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients
Phase 3
Recruiting
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Noiiglutide InjectionDrug: Noiiglutide Placebo
- Registration Number
- NCT06649773
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This study aims to confirm that SHR20004 is more effective than placebo in controlling blood glucose in patients with type 2 diabetes. Evaluate the efficacy, safety, and pharmacokinetics of SHR20004 after 24 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Noiiglutide Injection Noiiglutide Injection - Noiiglutide Placebo Noiiglutide Placebo -
- Primary Outcome Measures
Name Time Method Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo. Week 24
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Beijing Chaoyang Hospital Affiliated to Capital
🇨🇳Beijing, Beijing, China