Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

Sponsor

First Affiliated Hospital of Guangxi Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677334

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type2diabetes	Drug: Henagliflozin Device: Continuous Subcutaneous Insulin Infusion	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter, randomized, controlled studyMulticenter, randomized, controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Henagliflozin+ Continuous Subcutaneous Insulin Infusion Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion	Drug: Henagliflozin Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion Other Names: Continuous Subcutaneous Insulin Infusion Device: Continuous Subcutaneous Insulin Infusion Continuous Subcutaneous Insulin Infusion therapy alone
Active Comparator: Continuous Subcutaneous Insulin Infusion Continuous Subcutaneous Insulin Infusion therapy alone	Device: Continuous Subcutaneous Insulin Infusion Continuous Subcutaneous Insulin Infusion therapy alone

Arm

Intervention/Treatment

Experimental: Henagliflozin+ Continuous Subcutaneous Insulin Infusion

Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Drug: Henagliflozin

Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Other Names:

Continuous Subcutaneous Insulin Infusion

Device: Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion therapy alone

Active Comparator: Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion therapy alone

Device: Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion therapy alone

Outcome Measures

Primary Outcome Measures

Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose [Monitoring 7-14 days]
Compare the TIR of the two treatment groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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