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Phase 2 Type 2 Diabetes Trial, Not Yet Recruiting
NCT06789302
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 (men or women) between the ages of 30 and 75 years.
- People who have been diagnosed with Type 2 diabetes.
- People whose daily insulin requirement is 0.7 units per kilogram of body weight per day, or 50 units per day, whichever is the lower amount.
- People whose blood test for a specific antibody called GAD (glutamic acid decarboxylase) comes back negative.
- People with a Body Mass Index (BMI) between 19 and 30 kg/m².
- People whose fasting blood sugar level is 7.0 mmol/L or higher, and whose HbA1c (a measure of average blood sugar over time) is 7% or higher.
- People whose results from a specific insulin tolerance test show that their body is resistant to insulin (confirm with trial site).
- People who are able to move around independently and are in generally good health.
- People who are willing and able to follow the study procedures, attend scheduled visits, and understand verbal and written instructions.
- People who agree to avoid certain treatments that are restricted by the study protocol, from the initial screening visit through to the end of treatment.
- People who have no significant abnormalities found during their medical history review, physical examination, vital signs check, or laboratory tests.
- Women who could become pregnant must agree to use effective contraception for at least one month before the screening visit and continue using it until the end of the study, and must have a negative pregnancy test.
- Men who could father a child must agree to use condoms and other methods to ensure effective contraception with their partner.
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 Type 1 diabetes or diabetes caused by another medical condition.
- People whose blood creatinine level (a measure of kidney function) is 1.5 mg/dL or higher.
- People with abnormal liver function test results, specifically if certain liver enzyme levels are more than three times the upper limit of normal, or if bilirubin levels are above the normal reference range.
- People who have had a heart attack or unstable chest pain in the past three months.
- People who have a history of cancer, or currently have cancer, other than a specific type of non-serious skin cancer (non-melanomatous skin cancer).
- People who currently have an active infection.
- People with serious medical conditions other than heart disease (confirm with trial site).
- People who have, or have a history of, autoimmune diseases (conditions where the immune system attacks the body).
- People who have a history of a mental health disorder or epilepsy.
- People who drink alcohol more than 10 times per week or smoke 25 or more cigarettes per day.
- People who have been diagnosed with cancer within the five years before the screening visit.
- People who have taken part in another clinical trial within six months before the screening visit for this trial.
- People who have been given immunosuppressant medications — such as cyclosporin A or azathioprine — within six weeks before the screening visit.
- People with serious, life-threatening medical conditions.
- People who have an allergy to anaesthesia.
- People who are pregnant or breastfeeding.
- People who are on ongoing immunosuppressive therapy due to an organ transplant.
- People who have tested positive for HIV 1/2, Hepatitis B, Hepatitis C, HTLV I/II, West Nile Virus, or syphilis.
- People who currently have flu-like symptoms.
- People with any past history of certain fat tissue disorders, including lipedema, lipomatosis, or lipodystrophies.
- People who have had active cancer, received chemotherapy, or had another malignancy in the six months before the screening visit.
- People with a past history of deep vein thrombosis (DVT) or a blood clot in the lungs (pulmonary embolism) that required blood thinners or other medications.
- People who require supplemental oxygen.
- People who have had major surgery within six months before the screening visit.
- People who have had wounds or a serious blood infection (sepsis) that is ongoing or occurred within three months before the screening visit.
- People with any illness that, in the trial investigator's judgment, could interfere with following the study protocol, put the person's safety at risk, or affect the interpretation of the study results.
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.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Global Institute of Stem Cell Therapy and Research
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 June 2028
Primary endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants; Change from Baseline in Insulin Requirements at 6 Months Post-Treatment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.