Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-29 @ 1:44 PM
Study NCT ID:
NCT06925334
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-13
First Post:
2025-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TLI vs PMI
Brief 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.
Detailed Description:
Subjects eligible for inclusion press 1: 1. The proportion was randomly divided into the experimental group (Delu insulin liraglutide) and the control group (maintaining the original therapeutic drug). The first 14 days of the study was the dose adjustment period. The researchers timely adjusted the dosage of insulin or Delu insulin liraglutide according to the blood glucose monitoring results of the subjects, and the target value of blood glucose monitoring was set as fasting blood glucose \<7.5 mmol/l in the morning. The average fasting blood glucose of the last 3 days of the previous 14 days is less than 7.5mmol/l to enter the next stage (if the blood glucose is not up to standard, the dose adjustment period can be extended for up to 7 days). After 14 days, the dose was stable. The blood glucose was monitored by CGM (14 days), and the Time in Range (3.9-10 mmol/l) was compared.
Experimental group: 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.
Control group: The original therapy was maintained until the 4th week.
Experimental group: 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.
Control group: The original therapy was maintained until the 4th week.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: