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A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus (TLI vs PMI) Fase 4 170 Gerandomiseerd

Inschrijving op uitnodiging
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De klinische studie NCT06925334 (TLI vs PMI) onderzoekt behandeling bij Type 2 Diabetic Patients. Deze Fase 4 interventioneel-studie heeft de status inschrijving op uitnodiging. Het doel is om 170 deelnemers te includeren vanaf 20 mei 2024. De studie wordt geleid door Beijing Tsinghua Chang Gung Hospital en de voltooiing is gepland op 31 december 2025. Laatste update op ClinicalTrials.gov: 13 april 2025.
Beknopte samenvatting
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), ...Toon meer
Uitgebreide beschrijving
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 th...Toon meer
Officiële titel

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

Aandoeningen
Type 2 Diabetic Patients
Andere studie-ID's
  • TLI vs PMI
  • 4.0 20240522
NCT-ID
NCT06925334
Startdatum (Werkelijk)
2024-05-20
Laatste update geplaatst
2025-04-13
Verwachte einddatum
2025-12-31
Inschrijving (Geschat)
170
Studietype
Interventioneel
FASE
Fase 4
Status
Inschrijving op uitnodiging
Trefwoorden
Tegu insulin liraglutide injection
Premixed human insulin or insulin analogues
Chinese patients with type 2 diabetes
time in range，TIR
Randomized Controlled Trial，RCT
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelTreated with Degludec insulin
Experimental group: Delgol insulin liraglutide injection
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: I...Toon meer
Geen interventieControl group
Maintenance of original medication
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
GA（glycated albumin）
High pressure liquid phase method was used for sample determination, and glycosylated albumin analyzer was used for sample determination according to SOP
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
Changes in microflora were analyzed by 16SrRNA gene sequencing through the collection of stool samples at baseline and twice at the end of the dose stabilization period
From enrollment until the end of the study, expected to be 28 days
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Voluntarily sign the informed consent form;
  2. Male and female between the ages of 18 and 75 (inclusive);
  3. Diagnosed with type 2 diabetes mellitus according to WHO standards (1999) for more than 6 months;
  4. 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;
  5. Glycosylated hemoglobin > 7.0% and <=8.0% at screening;
  6. Body mass index (BMI) > 18 kg/m^2 and <=35 kg/m^2;
  7. Those who are willing and able to use the blood glucose meter for self-blood glucose monitoring according to the requirements of the program.

  1. People who are known to be allergic to Degu insulin or ingredients in its preparations;
  2. Human glucagon-like peptide-1 (GLP-1) receptor agonist has been used within 3 months before screening;
  3. Patients with hypoglycemic coma within 3 months before screening;
  4. Patients with severe ketosis or ketoacidosis within 1 month before screening;
  5. 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);
  6. 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);
  7. 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;
  8. 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;
  9. 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;
  10. Mental disorder, unwilling to communicate or language barriers, unable to fully understand, cooperate and use the blood glucose meter;
  11. 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;
  12. Participated in other drug or device clinical studies 3 months before participating in this study;
  13. Have a history of drug abuse and alcohol dependence in the past 5 years;
  14. 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);
  15. Patients deemed unsuitable for participation in this study by the investigator;
  16. Antibiotics and probiotics were used within 3 months before screening;
  17. Family history of medullary thyroid cancer or medullary thyroid cancer or family history of MEN.
Beijing Tsinghua Chang Gung Hospital logoBeijing Tsinghua Chang Gung Hospital
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Verantwoordelijke instantie
ZHAO WENHUI, Hoofdonderzoeker, clinical professor, Beijing Tsinghua Chang Gung Hospital
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Beijing Municipality

continuous glucose monitoring system（CGMS）, Beijing, Beijing Municipality, China