Clinical trial NCT05677334: Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2diabetes
Keywords: Continuous subcutaneous insulin infusion
sglt2i
Continuous Glucose Monitoring
Type 2 diabetes
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
timeFrame: Monitoring 5-14 days
Secondary outcomes:
measure: Time taken for TIR >70%
timeFrame: 5-14 days after treatment
measure: Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: 5-14 days after treatment
measure: time below range (TBR)
timeFrame: 5-14 days after treatment
measure: total insulin dosage
timeFrame: 5-14 days after treatment
measure: time above range (TAR)
timeFrame: 5-14 days after treatment
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
References: