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ENROLLING BY INVITATION
NCT06925334
PHASE4

A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus

Sponsor: Beijing Tsinghua Chang Gung Hospital

View on ClinicalTrials.gov

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.

Official title: Clinical Study Comparing Time to Glucose Attainment in Patients With Type 2 Diabetes Mellitus Treated With Degu Insulin Liraglutide Injection Versus Premixed Insulin

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2024-05-20

Completion Date

2025-12-31

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

Degludec insulin

The pre-mixed human insulin or insulin analogues were stopped, and the treatment was switched to Delgol insulin liraglutide injection. The initial dose was subcutaneous injection of 80% (not more than 16 units) of the full daily dose of medium-acting insulin in the original insulin, once a day, and the dose of Delgol insulin liraglutide injection was adjusted according to the fasting blood glucose level. Example 1: If the patient is currently using Novorin 30 20iu bid, the conversion calculation is 40\*70%\*80%=22.4 units, which should be 16 units; In example 2, the patient applied eubrine 50 20 IU bid, and the conversion calculation was 40\*50%\*80%=16 units.

Locations (1)

continuous glucose monitoring system(CGMS)

Beijing, Beijing Municipality, China