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
- A parent, legal guardian, or the child themselves (where age-appropriate) must agree to take part and sign the required consent forms before any study activities begin.
- The parent or legal guardian must sign and date the official consent form, following local requirements.
- The child must sign and date an assent form, or give spoken agreement, following local requirements.
- The child can be male or female.
- The child must be between 10 and 17 years old at the time consent is signed.
- The child must have been diagnosed with type 2 diabetes (following the latest international guidelines for children and young people with diabetes) at least 30 days before the screening visit.
- The child must currently be managing their diabetes with diet and exercise guidance alone, or with a stable dose of one or more of the following medications alongside diet and exercise: insulin (any type or regimen), metformin, or a type of medication called an SGLT2 inhibitor — with "stable dose" meaning: metformin at least 1000 mg daily or the highest tolerated dose for at least 56 days before screening; an SGLT2 inhibitor at the same daily dose for at least 56 days before screening; or insulin within 25% of the screening dose for at least 30 days before screening.
- The child's blood sugar control measure (HbA1c) must be between 6.5% and 11.0% as tested by the central laboratory at the screening visit.
- The child must weigh at least 45 kg and have a BMI at or above the 85th percentile for their age and sex, based on relevant country or regional growth charts (confirm with trial site if charts for your region are unclear).
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.
- Girls or young women who are pregnant, breastfeeding, planning to become pregnant, or who are able to become pregnant and are not using a highly effective form of contraception.
- Children who have taken any diabetes or weight-loss medication not listed in the inclusion criteria within the 90 days before the screening visit.
- Children who have a known or previously diagnosed condition called hypoparathyroidism (a problem with a gland that helps control calcium levels).
- Children who have previously had, or are planning to have during the study, surgery or a medical device used to treat obesity — although some past procedures may be allowed if they took place more than one year before screening and any device has since been removed (confirm specific details with the trial site).
- Children who test positive for certain antibodies (IA-2 or anti-GAD) associated with a different type of diabetes, either at the screening visit or in their medical history.
- Children who have had repeated severe low blood sugar episodes in the past year, as assessed by the study doctor.
- Children who are known to not feel the warning signs of low blood sugar, as determined by the study doctor using a standard questionnaire.
- Children with unstable or poorly controlled diabetes-related eye disease affecting the central part of the eye (the macula), confirmed by an eye examination performed within 90 days before screening or before the start of the study.
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
Principal Investigator: Clinical Transparency dept. 2834, Novo Nordisk A/S
Phone: (+1) 866-867-7178
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
Where this trial is recruiting
Primary endpoints
Change in glycated haemoglobin (HbA1c)
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.