Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Taizhou First People's Hospital | OTHER |
| Wenzhou Central Hospital | OTHER |
| Wenzhou People's Hospital | OTHER |
| Chaohu Hospital of Anhui Medical University |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with Degludec insulin | Experimental | Experimental group: Delgol insulin liraglutide injection |
|
| Control group | No Intervention | Maintenance of original medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| WenHui ZHAO | Beijing Tsinghua Chang Gung Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| continuous glucose monitoring system(CGMS) | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided
| OTHER |
| Affiliated Zhoushan Hospital of Wenzhou Medical University | OTHER |
| Yiwu Central Hospital | OTHER |
| Jinhua Municipal Central Hospital | OTHER |
| Dongyang People's Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| Jinhua People's Hospital | OTHER |
| Wuhu City Second People's Hospital | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
Randomized open, positive drug parallel control clinical study design
Not provided
Not provided
Not provided
Not provided
|
| 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 |