Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

Phase 4

Completed

• Conditions: Type2diabetes
• Interventions: Device: Continuous Subcutaneous Insulin Infusion; Drug: Henagliflozin

• Registration Number: NCT05677334
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

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

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 Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Study Start: 2023-03-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years
2. Age between 20 and 70 years
3. Continuous use of any hypoglycemic drug ≤ 7 days within 6 months
4. 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L
5. Body mass index (BMI) of between 20 and 32 kg/m2
6. Be able to understand the contents and methods of this study and sign the informed consent form voluntarily

Exclusion Criteria

1. Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications
2. Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history
3. Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control
4. 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
5. Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)
6. Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)
7. Uncontrolled hyperthyroidism
8. Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate
9. Pregnant or lactating women
10. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Subcutaneous Insulin Infusion	Continuous Subcutaneous Insulin Infusion	Continuous Subcutaneous Insulin Infusion therapy alone
Henagliflozin+ Continuous Subcutaneous Insulin Infusion	Continuous Subcutaneous Insulin Infusion	Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Henagliflozin+ Continuous Subcutaneous Insulin Infusion	Henagliflozin	Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Primary Outcome Measures

Name	Time	Method
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose	Monitoring 5-14 days	Compare the TIR of the two treatment groups

Secondary Outcome Measures

Name	Time	Method
Mean Amplitude of Glycemic Excursions (MAGE)	5-14 days after treatment	Compare the mage of the two treatment groups
Time taken for TIR >70%	5-14 days after treatment	Compare the time required for TIR \>70% of the two groups
time below range (TBR)	5-14 days after treatment	Compare the TBR of the two treatment groups
total insulin dosage	5-14 days after treatment	Compare the total insulin dosage of the two treatment groups
time above range (TAR)	5-14 days after treatment	Compare the TAR of the two treatment groups

Trial Locations

Locations (1)

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China