Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

March 9, 2025 updated by: First Affiliated Hospital of Guangxi Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
Time Frame: Monitoring 5-14 days
Compare the TIR of the two treatment groups
Monitoring 5-14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time taken for TIR >70%
Time Frame: 5-14 days after treatment
Compare the time required for TIR >70% of the two groups
5-14 days after treatment
Mean Amplitude of Glycemic Excursions (MAGE)
Time Frame: 5-14 days after treatment
Compare the mage of the two treatment groups
5-14 days after treatment
time below range (TBR)
Time Frame: 5-14 days after treatment
Compare the TBR of the two treatment groups
5-14 days after treatment
total insulin dosage
Time Frame: 5-14 days after treatment
Compare the total insulin dosage of the two treatment groups
5-14 days after treatment
time above range (TAR)
Time Frame: 5-14 days after treatment
Compare the TAR of the two treatment groups
5-14 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Guangxi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yingfen Qin, First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-K148-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables.figures, and appendices) will be shared.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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