A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study ID
- NCT07018453
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- SHR-3167 — DRUGSHR-3167 Injection.
- Insulin Degludec — DRUGInsulin Degludec Injection.
Study Details
The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.
Key Dates
- First listed
- Jun 12, 2025
- Start date
- Jul 16, 2025
- Status verified
- Nov 2025
- Primary completion
- Feb 28, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 173 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SHR-3167 Group A
- Experimental: SHR-3167 Group B
- Active Comparator: Insulin Degludec Group
Primary Outcome Measure
Change in glycosylated hemoglobin (HbA1c) from baseline. [ Time Frame: 16 weeks. ]
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