Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

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

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

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Drug: Henagliflozin; Device: Continuous Subcutaneous Insulin Infusion

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yingfen Qin, Ph.D.; Phone Number: 0771-5356517 13607862619; Email: yingfenq@126.com
• Study Contact Backup: Name: Zhenxing Huang, Ph.D.; Phone Number: 0771-5356517 13471009859; Email: huangzx11@126.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 18 and 28 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Yingfen Qin, First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 2 diabetes; Continuous subcutaneous insulin infusion; sglt2i
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2022-K148-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No