drugset / Trial / NCT06925334
A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus
Phase 4
Enrolling by invitation
170 enrolled
Beijing Tsinghua Chang Gung Hospital
Affiliated Hospital of Jiaxing University · collabAffiliated Hospital of Nantong University · collabAffiliated Zhoushan Hospital of Wenzhou Medical University · collabChaohu Hospital of Anhui Medical University · collabDongyang People's Hospital · collabJinhua Municipal Central Hospital · collabJinhua People's Hospital · collabTaizhou First People's Hospital · collabThe Central Hospital of Lishui City · collabWenzhou Central Hospital · collabWenzhou People's Hospital · collabWuhu City Second People's Hospital · collabYiwu Central Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized open, positive parallel controlled clinical study design was adopted. Participants were randomly assigned 1:1 according to inclusion criteria and exclusion criteria into two treatment regiments: Delu insulin liraglupeptide injection group and premixed insulin (or premixed insulin analogue). After fasting blood glucose was controlled at 7.5mmol /l in the morning, blood glucose was monitored by CGM (14d), and the Time in Range (3.9-10 mmol/l) was compared. Glycated albumin was measured and stool samples were taken before treatment and at 4 weeks.
Timeline
- Start
- 2024-05-20
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |