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

NCT06925334 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 4.0 20240522
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetic Patients

Keywords

Tegu insulin liraglutide injection; Premixed human insulin or insulin analogues; Chinese patients with type 2 diabetes; time in range，TIR; Randomized Controlled Trial，RCT

Outcome Measures

Primary Outcomes (1)

• Time to blood glucose compliance

  When morning fasting blood glucose was controlled at 7.5 mmol/l blood glucose was monitored using CGM to compare the time to reach blood glucose standard measured by CGM. Glucose attainment here is defined as a range of blood glucose control of 3.9-10 mmol/l

  From the time of enrollment and signing of informed consent, the program started when blood glucose was controlled at 7.5 mmol/l for 14 days

Secondary Outcomes (2)

• GA（glycated albumin）

  When subjects began 14 days of stable-dose insulin therapy, blood tests were performed at the end of treatment to measure glycated albumin

• Changes in intestinal flora

  From enrollment until the end of the study, expected to be 28 days

Study Arms (2)

Treated with Degludec insulin

EXPERIMENTAL

Experimental group: Delgol insulin liraglutide injection

Drug: Degludec insulin

Control group

NO INTERVENTION

Maintenance of original medication

Interventions

Degludec insulin DRUG

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.

Treated with Degludec insulin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form;
• Male and female between the ages of 18 and 75 (inclusive);
• Diagnosed with type 2 diabetes mellitus according to WHO standards (1999) for more than 6 months;
• Those who use premixed human insulin or insulin analogues with or without oral hypoglycemic drugs (which cannot contain secretagogues and DPP4 inhibitors) \>=3 months, and have poor blood sugar control;
• Glycosylated hemoglobin \> 7.0% and \<=8.0% at screening;
• Body mass index (BMI) \> 18 kg/m\^2 and \<=35 kg/m\^2;
• Those who are willing and able to use the blood glucose meter for self-blood glucose monitoring according to the requirements of the program.

You may not qualify if:

• People who are known to be allergic to Degu insulin or ingredients in its preparations;
• Human glucagon-like peptide-1 (GLP-1) receptor agonist has been used within 3 months before screening;
• Patients with hypoglycemic coma within 3 months before screening;
• Patients with severe ketosis or ketoacidosis within 1 month before screening;
• Severe complications of diabetes at the time of screening: such as severe proliferative diabetic retinopathy, a history of kidney transplantation, active peripheral vascular disease (such as diseases that have led to amputation, chronic foot ulcers, intermittent claudication, or require interventional procedures such as bypass or angioplasty);
• Severe hypertension that cannot be controlled by treatment (defined as systolic blood pressure of not less than 180mmHg and/or diastolic blood pressure of not less than 100mmHg);
• Patients with acute myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmia, or severe heart failure (NYHA grading ≥III) in the 12 months prior to screening; New cerebrovascular accidents (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months prior to screening;
• Liver and kidney function impairment: ALT, AST greater than 2.5 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal;
• Any conditions or co-existing diseases that the investigator determines may interfere with the test results, such as cardiovascular, respiratory, gastrointestinal, pancreatic, liver, kidney, nervous system, psychiatric, hematological (such as hematological tumors, hemolytic anemia, sickle cell disease, etc.), immune system, or other malignant tumors;
• Mental disorder, unwilling to communicate or language barriers, unable to fully understand, cooperate and use the blood glucose meter;
• Drugs that may have a significant effect on glucose metabolism, such as systemic corticosteroids, monoamine oxidase inhibitors, etc. are expected to be used within 3 months prior to screening;
• Participated in other drug or device clinical studies 3 months before participating in this study;
• Have a history of drug abuse and alcohol dependence in the past 5 years;
• Known pregnancies (determined by pregnancy tests at the time of screening), women who are preparing to become pregnant or are lactating at the time of the test, or women of childbearing age who are unable to take adequate contraception (adequate contraception means Iuds, oral contraceptives and barrier measures);
• Patients deemed unsuitable for participation in this study by the investigator;

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Taizhou First People's Hospital: collaborator
• Wenzhou Central Hospital: collaborator
• Wenzhou People's Hospital: collaborator
• Chaohu Hospital of Anhui Medical University: collaborator
• Affiliated Zhoushan Hospital of Wenzhou Medical University: collaborator
• Yiwu Central Hospital: collaborator
• Jinhua Municipal Central Hospital: collaborator
• Dongyang People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Jinhua People's Hospital: collaborator
• Wuhu City Second People's Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator

Study Sites (1)

continuous glucose monitoring system（CGMS）

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

insulin degludec

Study Officials

• WenHui ZHAO

  Beijing Tsinghua Chang Gung Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: Randomized open, positive drug parallel control clinical study design

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: April 13, 2025
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)