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New treatment option for Diabetes Mellitus, Type 2
Official title The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy
ClinicalTrials.gov ID: NCT06818851
What this study is testing
What is Henggliflozin?
Henggliflozin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for diabetes mellitus, type 2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- 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...
- HbA1c level above 8%.
- BMI ≥ 20 kg/m².
You likely can't join if
- 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...
- Volume depletion.
- Chronic (\>2 weeks) systemic glucocorticoid therapy or use of glucocorticoids within 4 weeks prior to screening (except for topical, intraocular...
See the full eligibility criteria
- 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.
- 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...
- 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).
- 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 how well it works or safety evaluation of the study.
- Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.