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Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

Primary Purpose

Type2diabetes

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Henagliflozin
Continuous Subcutaneous Insulin Infusion
Sponsored by
First Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes focused on measuring Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Affiliated Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Henagliflozin+ Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion

Arm Description

Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion

Continuous Subcutaneous Insulin Infusion therapy alone

Outcomes

Primary Outcome Measures

Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
Compare the TIR of the two treatment groups

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2022
Last Updated
May 6, 2023
Sponsor
First Affiliated Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05677334
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes
Keywords
Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Henagliflozin+ Continuous Subcutaneous Insulin Infusion
Arm Type
Experimental
Arm Description
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Arm Title
Continuous Subcutaneous Insulin Infusion
Arm Type
Active Comparator
Arm Description
Continuous Subcutaneous Insulin Infusion therapy alone
Intervention Type
Drug
Intervention Name(s)
Henagliflozin
Other Intervention Name(s)
Continuous Subcutaneous Insulin Infusion
Intervention Description
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Intervention Type
Device
Intervention Name(s)
Continuous Subcutaneous Insulin Infusion
Intervention Description
Continuous Subcutaneous Insulin Infusion therapy alone
Primary Outcome Measure Information:
Title
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
Description
Compare the TIR of the two treatment groups
Time Frame
Monitoring 7-14 days
Secondary Outcome Measure Information:
Title
Time taken for TIR >70%
Description
Compare the time required for TIR >70% of the two groups
Time Frame
7-14 days after treatment
Title
Mean Amplitude of Glycemic Excursions (MAGE)
Description
Compare the mage of the two treatment groups
Time Frame
7-14 days after treatment
Title
time below range (TBR)
Description
Compare the TBR of the two treatment groups
Time Frame
7-14 days after treatment
Title
total insulin dosage
Description
Compare the total insulin dosage of the two treatment groups
Time Frame
7-14 days after treatment
Title
time above range (TAR)
Description
Compare the TAR of the two treatment groups
Time Frame
7-14 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingfen Qin, Ph.D.
Phone
13607862619
Ext
0771-5356517
Email
yingfenq@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenxing Huang, Ph.D.
Phone
13471009859
Ext
0771-5356517
Email
huangzx11@126.com
Facility Information:
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

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