Printed from Voxsanity (voxsanity.com.au) — NCT06448130 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Type 2 Diabetes Trial, Not Yet Recruiting
NCT06448130
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults between 18 and 65 years old, either male or female.
- People who have never previously taken any blood sugar-lowering treatments, including prescription medications or traditional Chinese medicine products that lower blood sugar.
- People with prediabetes, defined by having a fasting blood sugar level between 6.1 and 7.0 mmol/L and/or a blood sugar level of 7.8 to 11.1 mmol/L two hours after eating, and/or a HbA1c (a measure of average blood sugar over roughly three months) between 5.7% and 6.5%.
- People who are willing to sign a consent form and are able to follow the study procedures and attend follow-up appointments.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have a known allergy to Henagliflozin (the study medication).
- People who have already been diagnosed with diabetes.
- People whose blood sugar levels meet or exceed the thresholds for a diabetes diagnosis (HbA1c of 6.5% or higher, fasting blood sugar of 7.0 mmol/L or higher, or two-hour post-meal blood sugar of 11.1 mmol/L or higher).
- People who have used GLP-1 receptor agonist medications, orlistat, or other weight-loss drugs in the past three months.
- People whose body weight has changed by 5% or more in the past month.
- People currently using certain medications that can affect blood sugar levels, such as steroids (e.g., prednisone, dexamethasone), hormonal contraceptives, growth hormone, hormone replacement therapy (estrogen or progesterone), immune-suppressing drugs (e.g., cyclosporine A, tacrolimus), or tuberculosis medications (e.g., isoniazid, rifampicin).
- People with an untreated thyroid condition (overactive or underactive thyroid), unless thyroid function has returned to normal with treatment.
- People with high blood pressure that has not been brought under control despite medication in the three months before enrolment, or people currently taking three or more blood pressure medications (including water tablets/diuretics).
- People assessed by the study doctor as being at high risk of urinary or genital infections, such as those with a history of repeated urinary tract infections, long-term use of a urinary catheter, or prior urological surgery.
- People whose excess weight is caused by a hormonal condition such as Cushing's syndrome.
- People with significantly elevated liver enzyme levels (ALT or AST more than three times the upper limit of the normal range).
- People with severely reduced kidney function, an eGFR below 30 mL/min/1.73 m², end-stage kidney disease, or those requiring dialysis.
- People with serious heart or blood vessel conditions, including a previous heart attack, moderate-to-severe heart failure, a heart pumping capacity of 40% or less, or a previous stroke.
- People with impaired consciousness or a diagnosed mental health disorder.
- People with cancer or other serious illnesses.
- People who are pregnant, breastfeeding, or planning to become pregnant within the next 24 months.
- People who are currently enrolled in another clinical trial or who have been in one within the past three months.
- People whom the study doctor considers unlikely to complete the long-term trial, for example due to travel, work commitments, family caring responsibilities, or other non-medical reasons that may lead to withdrawal.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Phone: +8613186067538
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Shandong Provincial Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
1 December 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Normoglycemia Achievement Rates Post-6-Month Intervention
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.