Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
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
- People who are willing to take part voluntarily and agree to sign and date a consent form confirming this.
- People who have been diagnosed with type 2 diabetes and whose blood sugar levels have not reached the recommended target through diet, physical activity, and taking the highest tolerated dose of metformin (kept stable for at least the last 3 months), and where the treating doctor believes adding the trial medicines could help.
- People whose HbA1c level (a measure of average blood sugar over time) was between 7.5% and 10.5% at the initial screening appointment.
- People whose body mass index (BMI, a measure of body weight relative to height) is 45 or below.
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 whose doctor identifies a clinical finding or test result that suggests participating in the trial could pose a risk to their health, or who have one or more long-term conditions that are not well controlled.
- People with a history of alcohol or illicit drug use disorder within the last two years.
- People who are pregnant, breastfeeding, or planning to become pregnant, or women who could become pregnant and are not using reliable contraception.
- People who have a known allergy or sensitivity to any ingredient in the medicines being used in the trial.
- People who currently have cancer or have received cancer treatment within the last five years.
- People who have taken part in another clinical trial within the last 12 months, unless the treating doctor determines there may be a direct benefit to the person from joining (confirm with trial site).
- People who have type 1 diabetes.
- People whose fasting blood glucose level is above 300 mg/dL.
- People who have risk factors that may lead to a significant loss of fluid from the body.
- People who are currently on dialysis (a kidney treatment that filters the blood).
- People with a history of a condition where the blood becomes too acidic (metabolic acidosis), or who are taking medicines that may cause lactic acidosis (a build-up of lactic acid in the blood).
- People who have had a serious heart or blood vessel event in the six months before screening — such as a heart attack, stroke, newly developed chest pain, unstable heart failure requiring a change in treatment — or who have had a heart bypass or blood vessel surgery during that time.
- People with a known diagnosis of heart failure rated as class III or IV by their doctor (meaning moderate to severe heart failure).
- People with moderate or severe kidney disease.
- People whose liver function tests show levels significantly above the normal range, as defined by specific blood test measurements (confirm with trial site for exact values).
- People who have had bariatric (weight loss) surgery in the last two years, or other bowel or stomach surgeries that may cause long-term problems with absorbing nutrients.
- People with a known history of inherited blood disorders affecting haemoglobin, disorders of the blood cells, or any other condition that causes the breakdown of red blood cells.
- People with a known history of pancreatic disease that may indicate the body is not producing enough insulin.
- People with known uncontrolled thyroid conditions (either an underactive or overactive thyroid), or whose thyroid-stimulating hormone (TSH) test result is more than 1.5 times the upper limit of the normal range.
- People with a known history — within the six months before screening — of serious infection (sepsis), low blood pressure, major surgery, serious injury, significant changes in metabolism, hormones or electrolytes, or uncontrolled seizures; or people whose blood test shows a muscle enzyme called CPK is more than ten times the normal level; or anyone whose doctor believes their CPK levels could be significantly affected by their condition.
- People who started taking anti-obesity (weight loss) medication less than three months ago, or whose dose of such medication changed within the last three months.
- People who are currently taking, or have taken within the last three months, systemic steroid medicines continuously for more than fifteen days.
- People who are currently on insulin therapy or taking any diabetes medicines other than metformin.
- People who are taking any other medicines that are listed as prohibited under the study protocol (confirm with trial site for the specific list).
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.
Contact this trial
Phone: 1938878917
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Glycated hemoglobin (HbA1c)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.