Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

Study Overview
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Brief Summary
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The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes

Detailed Description
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The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on continuous glucose monitoring system.

Official Title
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Study on the Efficacy and Safety of Henagliflozin Combined With Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System

Conditions
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Type2diabetes

Intervention / Treatment
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* Drug: Henagliflozin
* Device: Continuous Subcutaneous Insulin Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years Age between 20 and 70 years Continuous use of any hypoglycemic drug ≤ 7 days within 6 months 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L Body mass index (BMI) of between 18 and 28 kg/m2 Be able to understand the contents and methods of this study and sign the informed consent form voluntarily Exclusion Criteria: Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control People with negligent compensatory heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, serious arrhythmia, cardiac surgery or vascular reconstruction within 6 months Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia) Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) Uncontrolled hyperthyroidism Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate Pregnant or lactating women ALT>3.0x ULN and/or AST>3.0x ULN and/or Tbil>2.0x ULN Blood ketone body>ULN eGFR<30ml/min/1.73 m2 Blood creatine kinase>3.0x ULN

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Henagliflozin+ Continuous Subcutaneous Insulin Infusion<br>Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion | Drug: Henagliflozin<br>* Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion<br>* Other names: Continuous Subcutaneous Insulin Infusion;Device: Continuous Subcutaneous Insulin Infusion<br>* Continuous Subcutaneous Insulin Infusion therapy alone<br>|
| Active Comparator: Continuous Subcutaneous Insulin Infusion<br>Continuous Subcutaneous Insulin Infusion therapy alone | Device: Continuous Subcutaneous Insulin Infusion<br>* Continuous Subcutaneous Insulin Infusion therapy alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time percentage (% TIR) in the range of 3.9 10.0 mmol/L blood glucose | Compare the TIR of the two treatment groups | Monitoring 7-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken for TIR >70% | Compare the time required for TIR >70% of the two groups | 7-14 days after treatment | 
| Mean Amplitude of Glycemic Excursions (MAGE) | Compare the mage of the two treatment groups | 7-14 days after treatment | 
| time below range (TBR) | Compare the TBR of the two treatment groups | 7-14 days after treatment | 
| total insulin dosage | Compare the total insulin dosage of the two treatment groups | 7-14 days after treatment | 
| time above range (TAR) | Compare the TAR of the two treatment groups | 7-14 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes