Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

NCT05677334 | Completed Phase 4

• 1 other identifier: 2022-K148-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Type2diabetes

Keywords

Continuous subcutaneous insulin infusion; sglt2i; Continuous Glucose Monitoring; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose

  Compare the TIR of the two treatment groups

  Monitoring 5-14 days

Secondary Outcomes (5)

• Time taken for TIR >70%

  5-14 days after treatment

• Mean Amplitude of Glycemic Excursions (MAGE)

  5-14 days after treatment

• time below range (TBR)

  5-14 days after treatment

• total insulin dosage

  5-14 days after treatment

• time above range (TAR)

  5-14 days after treatment

Study Arms (2)

Henagliflozin+ Continuous Subcutaneous Insulin Infusion

EXPERIMENTAL

Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Drug: Henagliflozin; Device: Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion

ACTIVE COMPARATOR

Continuous Subcutaneous Insulin Infusion therapy alone

Device: Continuous Subcutaneous Insulin Infusion

Interventions

Henagliflozin DRUG

Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Also known as: Continuous Subcutaneous Insulin Infusion

Henagliflozin+ Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion DEVICE

Continuous Subcutaneous Insulin Infusion therapy alone

Continuous Subcutaneous Insulin Infusion; Henagliflozin+ Continuous Subcutaneous Insulin Infusion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L
• Body mass index (BMI) of between 20 and 32 kg/m2
• Be able to understand the contents and methods of this study and sign the informed consent form voluntarily

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (1)

• Wu Y, Huang Z, Qin Y. Efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion in the treatment of Chinese inpatients with type 2 diabetes mellitus based on a continuous glucose monitoring system: protocol of a multicentre, open-label, inpatient, randomised, controlled trial. BMJ Open. 2024 Oct 11;14(10):e084834. doi: 10.1136/bmjopen-2024-084834.

  PMID: 39395826 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, controlled study

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 10, 2023
• Study Start: March 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Investigators could contact the corresponding author. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)