The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients

Phase 3

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Noiiglutide Injection; Drug: 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

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-21
• Study Start: 2024-10-25
• Primary Completion: 2025-05-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-05
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 137

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 26

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who achieve the HbA1c target value (<7.0%)	Week 26
The proportion of subjects who achieve the HbA1c target value (≤ 6.5%)	Week 26
Changes in fasting plasma glucose relative to baseline	Week 26
Changes in fasting body weight relative to baseline	Week 26
Changes in plasma glucose levels relative to baseline 2 hours after meals	Week 26
7-point self-test of blood glucose (SMBG) spectrum relative to baseline changes	Week 26
Changes in blood pressure relative to baseline	Week 26
Changes in fasting insulin relative to baseline	Week 26
Changes in C-peptide relative to baseline	Week 26
Changes in insulin levels relative to baseline 2 hours after meals	Week 26
Changes in C-peptide levels relative to baseline 2 hours after meals	Week 26
Adverse events (AE)	Week 26
ADA of SHR20004	Week 26
Nab of SHR20004	Week 26
The concentration of SHR20004 in plasma at steady state	Week 26

Trial Locations

Locations (1)

Beijing Chaoyang Hospital Affiliated to Capital; 🇨🇳 Beijing, Beijing, China