Diabetes Mellitus, Type 2Phase 4HOLIDYANCT06818851
The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
A Phase 4 study testing Henggliflozin in people with Diabetes Mellitus, Type 2, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if SGLT2 inhibitor Henggliflozin works to improve glucose variability in type 2 diabetes and if Henggliflozin can benefit immunosenescence. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Henggliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2025to 30 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months based on the 1999 WHO criteria.
- Age between 50 and 70 years at the time of signing the informed consent form (inclusive).
- Poor glycemic control despite treatment with basal insulin or insulin degludec/aspart (with or without oral antidiabetic drugs) within the 3 months prior to screening.
- HbA1c level above 8%.
- BMI ≥ 20 kg/m².
- C-peptide levels within the normal reference range.
- Able to maintain stable dietary and exercise habits during the study.
- Capable of understanding the study procedures and methods, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.
Who cannot join
- Patients considered by the investigator to have potential allergies to the components of the study drug or drugs of the same class.
- Use of SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to screening.
- Adjustments to antidiabetic treatment regimens within 3 months prior to screening.
- Hospitalization due to acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit.
- Volume depletion.
- Chronic (>2 weeks) systemic glucocorticoid therapy or use of glucocorticoids within 4 weeks prior to screening (except for topical, intraocular, intranasal, or inhaled administration).
Show all 15Show fewer
- Pregnancy, lactation, or plans for pregnancy within the next 6 months.
- Persistently elevated serum transaminase levels (more than 3 times the upper limit of normal).
- Renal impairment (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m²).
- History of malignant tumors.
- Presence of acute complications (e.g., ketoacidosis, diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma).
- Systemic autoimmune diseases, such as systemic lupus erythematosus.
- Clinically significant urinary tract infections and/or genital infections, or a history of recurrent urinary tract and/or genital infections.
- Any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of the study.
- Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine, Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Hongmei Zhang, PHD, +8613636347760, spicygirlss@126.com
About this study
Official title: The Effects of Henagliflozin on glucOse fLuctuation and Immunosenescence in Type 2 Diabetes pAtients on Insulin therapY: a Multicenter, Randomized, Double-blind, Placebo-controlled Study (the HOLIDYA Study)
The goal of this clinical trial is to learn if SGLT2 inhibitor Henggliflozin works to improve glucose variability in type 2 diabetes and if Henggliflozin can benefit immunosenescence.
The main questions it aims to answer are:
Read more
Does Henggliflozin as an add on treatment works to improve blood glucose fluctuation in type 2 diabetes? Does Henggliflozin has extra benefits like improve immunosenescence beyond hypoglycemic effects? Researchers will compare Henggliflozin to a placebo to see if Henggliflozin can improve glucose variability and immunosenescence.
Participants will:
Take Henggliflozin or a placebo every day for 16 weeks. Receive weekly follow-up calls to guide them in adjusting their insulin doses. Return for an on-site visit at 4 weeks and 16 weeks. Take a continuous glucose monitoring (CGM) for 7 days at the Visit 1 and at the end of the study.
Read the detailed description
With the rising prevalence of diabetes, complications associated with the disease are becoming a significant threat to human health. The primary goal of diabetes treatment is to delay the onset of macrovascular and microvascular complications and to reduce cardiovascular disease (CVD)-related mortality. Numerous clinical studies have explored the relationship between glycemic variability (GV) and the risk of macrovascular disease. Recent research has shown that GV is closely associated with endothelial cell damage, which represents an early stage of atherosclerosis and serves as a predictive factor for CVD.
The mean amplitude of glycemic excursions (MAGE), a marker of daily GV related to postprandial hyperglycemia or hypoglycemia, is a critical determinant of the severity of coronary artery disease and an independent predictor of mortality risk. Over the long term, reducing daily GV can help lower cardiovascular events and mitigate cognitive decline in patients. Therefore, controlling GV is particularly important in reducing the risk of cardiovascular disease.
While there is no strong evidence yet to suggest that suppressing GV can directly reverse cardiovascular events, some studies indicate that antidiabetic medications that reduce GV can improve surrogate markers of cardiovascular risk factors. Sodium-glucose cotransporter 2 (SGLT2) inhibitors lower blood glucose by promoting glucose excretion through urine. Research has demonstrated that SGLT2 inhibitors can reduce cardiovascular risks; however, studies on their effect in suppressing GV remain insufficient.
This study is a multicenter, randomized, double-blind controlled trial aiming to enroll 64 participants with type 2 diabetes.
Eligible participants will be randomly assigned to one of two groups in a 1:1 ratio:
- Henggliflozin Group (n=32): Henggliflozin 10 mg, once daily.
- Placebo Control Group (n=32): Placebo, once daily.
Upon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system. After the preliminary assessment, participants will receive either Henggliflozin 10 mg or a placebo once daily by oral administration for up to 16 weeks.
During the treatment period, weekly follow-up calls will be conducted to guide participants in adjusting their insulin doses until fasting blood glucose (FBG) reaches the target level (<7 mmol/L). Participants will return for an on-site visit at 4 weeks, during which medications will be retrieved, and relevant information recorded. Other antidiabetic medications, such as metformin, sulfonylureas, glinides, thiazolidinediones, or α-glucosidase inhibitors, may continue to be used at unchanged doses throughout the study. Participants will be encouraged to maintain their dietary and exercise regimens. If there is a risk of hypoglycemia, insulin doses may be reduced.
At the end of the 16-week treatment period, medications will be retrieved again, and fasting blood and urine samples will be collected. Glucose monitoring will be repeated using the CGM system. A safety follow-up call will be conducted two weeks after the end of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Henggliflozin, Placebo
- Keywords
- Sodium-glucose cotransporter 2, glycemic variability, immunosenescence
- 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.
HenggliflozinDrug
Upon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receiveHenggliflozin 10 mg once daily by oral administration for up to 16 weeks.
PlaceboOther
Upon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receive a placebo once daily by oral administration for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Henggliflozin 10mg per day for 16 weeks Receives: Drug: Henggliflozin |
| Control Group | Placebo comparator | Placebo 10mg per day for 16 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (1)
Change from Baseline in the immunophenotype of peripheral blood mononuclear cells at 16 weeks
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start14 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qing Su, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818851
- Sponsor's protocol ID
- XH-24-011
- Acronym
- HOLIDYA
- Status last verified
- Dec 2024
- First submitted
- 23 Jan 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Henagliflozin on glucOse fLuctuation and Immunosenescence in Type 2 Diabetes pAtients on Insulin therapY: a Multicenter, Randomized, Double-blind, Placebo-controlled Study (the HOLIDYA Study)
- ClinicalTrials.gov ID
- NCT06818851
- Acronym / sponsor ID
- HOLIDYA / XH-24-011
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Sodium-glucose cotransporter 2, glycemic variability, immunosenescence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 11 Feb 2025 (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 goal of this clinical trial is to learn if SGLT2 inhibitor Henggliflozin works to improve glucose variability in type 2 diabetes and if Henggliflozin can benefit immunosenescence.
The main questions it aims to answer are:
Does Henggliflozin as an add on treatment works to improve blood glucose fluctuation in type 2 diabetes? Does Henggliflozin has extra benefits like improve immunosenescence beyond hypoglycemic effects? Researchers will compare Henggliflozin to a placebo to see if Henggliflozin can improve glucose variability and immunosenescence.
Participants will:
Take Henggliflozin or a placebo every day for 16 weeks. Receive weekly follow-up calls to guide them in adjusting their insulin doses. Return for an on-site visit at 4 weeks and 16 weeks. Take a continuous glucose monitoring (CGM) for 7 days at the Visit 1 and at the end of the study.
Detailed description
With the rising prevalence of diabetes, complications associated with the disease are becoming a significant threat to human health. The primary goal of diabetes treatment is to delay the onset of macrovascular and microvascular complications and to reduce cardiovascular disease (CVD)-related mortality. Numerous clinical studies have explored the relationship between glycemic variability (GV) and the risk of macrovascular disease. Recent research has shown that GV is closely associated with endothelial cell damage, which represents an early stage of atherosclerosis and serves as a predictive factor for CVD.
The mean amplitude of glycemic excursions (MAGE), a marker of daily GV related to postprandial hyperglycemia or hypoglycemia, is a critical determinant of the severity of coronary artery disease and an independent predictor of mortality risk. Over the long term, reducing daily GV can help lower cardiovascular events and mitigate cognitive decline in patients. Therefore, controlling GV is particularly important in reducing the risk of cardiovascular disease.
While there is no strong evidence yet to suggest that suppressing GV can directly reverse cardiovascular events, some studies indicate that antidiabetic medications that reduce GV can improve surrogate markers of cardiovascular risk factors. Sodium-glucose cotransporter 2 (SGLT2) inhibitors lower blood glucose by promoting glucose excretion through urine. Research has demonstrated that SGLT2 inhibitors can reduce cardiovascular risks; however, studies on their effect in suppressing GV remain insufficient.
This study is a multicenter, randomized, double-blind controlled trial aiming to enroll 64 participants with type 2 diabetes.
Eligible participants will be randomly assigned to one of two groups in a 1:1 ratio:
- Henggliflozin Group (n=32): Henggliflozin 10 mg, once daily.
- Placebo Control Group (n=32): Placebo, once daily.
Upon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system. After the preliminary assessment, participants will receive either Henggliflozin 10 mg or a placebo once daily by oral administration for up to 16 weeks.
During the treatment period, weekly follow-up calls will be conducted to guide participants in adjusting their insulin doses until fasting blood glucose (FBG) reaches the target level (<7 mmol/L). Participants will return for an on-site visit at 4 weeks, during which medications will be retrieved, and relevant information recorded. Other antidiabetic medications, such as metformin, sulfonylureas, glinides, thiazolidinediones, or α-glucosidase inhibitors, may continue to be used at unchanged doses throughout the study. Participants will be encouraged to maintain their dietary and exercise regimens. If there is a risk of hypoglycemia, insulin doses may be reduced.
At the end of the 16-week treatment period, medications will be retrieved again, and fasting blood and urine samples will be collected. Glucose monitoring will be repeated using the CGM system. A safety follow-up call will be conducted two weeks after the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: HenggliflozinHenggliflozin 10mg per day for 16 weeks |
| Control Group | Placebo comparator | Other: PlaceboPlacebo 10mg per day for 16 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months based on the 1999 WHO criteria.
Key exclusion criteria (15 listed)
- Patients considered by the investigator to have potential allergies to the components of the study drug or drugs of the same class.
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 |
|---|---|---|
| HenggliflozinUpon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receiveHenggliflozin 10 mg once daily by oral administration for up to 16 weeks. | Drug | Experimental Group |
| PlaceboUpon enrollment, at Visit 1 (baseline), overnight fasting blood and urine samples will be collected, and glucose levels will be monitored for 3-5 days using a continuous glucose monitoring (CGM) system (Medtronic MiniMed). After the preliminary assessment, participants will receive a placebo once daily by oral administration for up to 16 weeks. | Other | Control Group |
Primary outcome
Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks
Time frame: From enrollment to the end of treatment at 16 weeks
1 secondary outcome
Change from Baseline in the immunophenotype of peripheral blood mononuclear cells at 16 weeks
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Qing Su study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Henggliflozin in people with Diabetes Mellitus, Type 2, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 20 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Zhang (+8613636347760, spicygirlss@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the mean amplitude of glycemic excursions at 16 weeks (time frame: From enrollment to the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.