Type 2 Diabetic PatientsPhase 4TLI vs PMINCT06925334
A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus
A Phase 4 study testing Degludec insulin in people with Type 2 Diabetic Patients, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetic Patients
- What is being tested?
- Degludec insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Antibiotics and probiotics were used within 3 months before screening;
- Family history of medullary thyroid cancer or medullary thyroid cancer or family history of MEN.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
continuous glucose monitoring system（CGMS）
Beijing, Beijing Municipality
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetic Patients
- Being tested
- Degludec insulin
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degludec insulinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated with Degludec insulin | Experimental | Experimental group: Delgol insulin liraglutide injection Receives: Drug: Degludec insulin |
| Control group | No intervention | Maintenance of original medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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）
High pressure liquid phase method was used for sample determination, and glycosylated albumin analyzer was used for sample determination according to SOP
Measured: 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
Measured: From enrollment until the end of the study, expected to be 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start20 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open, positive drug parallel control clinical study design
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou First People's Hospital, Wenzhou Central Hospital, Wenzhou People's Hospital, Chaohu Hospital of Anhui Medical University, Affiliated Zhoushan Hospital of Wenzhou Medical University, Yiwu Central Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, The Central Hospital of Lishui City, Affiliated Hospital of Jiaxing University, Jinhua People's Hospital, Wuhu City Second People's Hospital, Affiliated Hospital of Nantong University
- Responsible party
- Principal investigator, ZHAO WENHUI, Beijing Tsinghua Chang Gung Hospital
- Investigators
- WenHui ZHAO, Study chair, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925334
- Sponsor's protocol ID
- 4.0 20240522
- Acronym
- TLI vs PMI
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06925334
- Acronym / sponsor ID
- TLI vs PMI / 4.0 20240522
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Taizhou First People's Hospital, Wenzhou Central Hospital, Wenzhou People's Hospital, Chaohu Hospital of Anhui Medical University, Affiliated Zhoushan Hospital of Wenzhou Medical University, Yiwu Central Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, The Central Hospital of Lishui City, Affiliated Hospital of Jiaxing University, Jinhua People's Hospital, Wuhu City Second People's Hospital, Affiliated Hospital of Nantong University
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open, positive drug parallel control clinical study design
| Arm | Type | Receives |
|---|---|---|
| Treated with Degludec insulin | Experimental | Drug: Degludec insulinExperimental group: Delgol insulin liraglutide injection |
| Control group | No intervention | –Maintenance of original medication |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degludec insulinThe 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. | Drug | Treated with Degludec insulin |
Primary outcome
Time to blood glucose compliance
Time frame: 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
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
2 secondary outcomes
GA（glycated albumin）
Time frame: 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
Time frame: From enrollment until the end of the study, expected to be 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
WenHui ZHAO study chair
Beijing Tsinghua Chang Gung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Degludec insulin in people with Type 2 Diabetic Patients, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to blood glucose compliance (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.