To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
NCT05699408 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 513
Last updated 2025-02-18
Summary
The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
Conditions
Interventions
- DRUG
-
INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
- DRUG
-
Insulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2024-11-23
- Completion
- 2024-11-23
Countries
- China
Study Locations
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