Type2diabetesPhase 4NCT05677334
Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM
A Phase 4 study testing Henagliflozin and Continuous Subcutaneous Insulin Infusion in people with Type2diabetes, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Henagliflozin and Continuous Subcutaneous Insulin Infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 20 and 32 kg/m2
- Be able to understand the contents and methods of this study and sign the informed consent form voluntarily
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
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
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
Read the 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.
- Conditions
- Type2diabetes
- Being tested
- Henagliflozin, Continuous Subcutaneous Insulin Infusion
- Keywords
- Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HenagliflozinDrug
Also called Continuous Subcutaneous Insulin Infusion
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Continuous Subcutaneous Insulin InfusionDevice
Continuous Subcutaneous Insulin Infusion therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin+ Continuous Subcutaneous Insulin Infusion | Experimental | Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion Receives: Drug: Henagliflozin; Device: Continuous Subcutaneous Insulin Infusion |
| Continuous Subcutaneous Insulin Infusion | Active comparator | Continuous Subcutaneous Insulin Infusion therapy alone Receives: Device: Continuous Subcutaneous Insulin Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
Compare the TIR of the two treatment groups
Measured: Monitoring 5-14 days
Secondary outcomes (5)
Time taken for TIR >70%
Compare the time required for TIR >70% of the two groups
Measured: 5-14 days after treatment
Mean Amplitude of Glycemic Excursions (MAGE)
Compare the mage of the two treatment groups
Measured: 5-14 days after treatment
time below range (TBR)
Compare the TBR of the two treatment groups
Measured: 5-14 days after treatment
total insulin dosage
Compare the total insulin dosage of the two treatment groups
Measured: 5-14 days after treatment
time above range (TAR)
Compare the TAR of the two treatment groups
Measured: 5-14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Mar 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677334
- Sponsor's protocol ID
- 2022-K148-01
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables.figures, and appendices) will be shared.
Publications
Huang Z, Wu Y, Tang C, Yao B, Xie X, Bin X, Yan X, Deng T, Yang W, Chen G, Zhang Y, Wei W, Yang B, Peng T, Zhuo L, Li Y, He Y, Ma S, Qin Y. A Multicentre, Randomised, Controlled, Open-Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia. Diabetes Obes Metab. 2026 Jun;28(6):4806-4817. doi: 10.1111/dom.70665. Epub 2026 Mar 19.
PubMed 41853855Wu 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.
PubMed 39395826
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05677334
- Acronym / sponsor ID
- 2022-K148-01
- Conditions
- Type2diabetes
- Keywords
- Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin+ Continuous Subcutaneous Insulin Infusion | Experimental | Drug: Henagliflozin, Device: Continuous Subcutaneous Insulin InfusionCombination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion |
| Continuous Subcutaneous Insulin Infusion | Active comparator | Device: Continuous Subcutaneous Insulin InfusionContinuous Subcutaneous Insulin Infusion therapy alone |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 20 and 32 kg/m2
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HenagliflozinAlso: Continuous Subcutaneous Insulin InfusionCombination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion | Drug | Henagliflozin+ Continuous Subcutaneous Insulin Infusion |
| Continuous Subcutaneous Insulin InfusionContinuous Subcutaneous Insulin Infusion therapy alone | Device | Continuous Subcutaneous Insulin Infusion, Henagliflozin+ Continuous Subcutaneous Insulin Infusion |
Primary outcome
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
5 secondary outcomes
Time taken for TIR >70%
Time frame: 5-14 days after treatment
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: 5-14 days after treatment
time below range (TBR)
Time frame: 5-14 days after treatment
total insulin dosage
Time frame: 5-14 days after treatment
time above range (TAR)
Time frame: 5-14 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 41853855Huang Z, Wu Y, Tang C, Yao B, Xie X, Bin X, Yan X, Deng T, Yang W, Chen G, Zhang Y, Wei W, Yang B, Peng T, Zhuo L, Li Y, He Y, Ma S, Qin Y. A Multicentre, Randomised, Controlled, Open-Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia. Diabetes Obes Metab. 2026 Jun;28(6):4806-4817. doi: 10.1111/dom.70665. Epub 2026 Mar 19.
- Derived from this study: PubMed 39395826Wu 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables.figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henagliflozin and Continuous Subcutaneous Insulin Infusion in people with Type2diabetes, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose (time frame: Monitoring 5-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.