Phase 3 Type 1 Diabetes Trial, Recruiting NCT07076199 Sponsor: Novo Nordisk A/S Condition: Type 1 Diabetes
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Phase 3 Type 1 Diabetes Trial, Recruiting

NCT07076199
Recruiting Phase 3 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • People who have been diagnosed with type 1 diabetes for at least 1 year before the screening visit.
  • People who have been using a daily long-acting insulin injection plus a fast-acting insulin injection regimen for at least 6 months before the screening visit.
  • People whose HbA1c (a blood test that shows average blood sugar levels over roughly 3 months) falls between 7.0% and 10.0%, confirmed by a central laboratory at screening.
  • People who are willing and able to follow the study requirements, including regularly checking and recording their own blood sugar levels, as assessed by the study doctor.

Who may not be able to join:

  • People with a known or suspected allergy or sensitivity to the study treatment or closely related products.
  • People who have previously signed a consent form to participate in this same study.
  • People who are pregnant, breastfeeding, planning to become pregnant, or who are able to become pregnant and are not using an appropriate method of contraception.
  • People who have taken part in another clinical trial involving an experimental medicine within 90 days (or longer, depending on how long that medicine stays in the body) before screening.
  • People who have any other health condition — unrelated to type 1 diabetes — that the study doctor believes could affect their safety or ability to follow the study requirements.
  • People who are expected to start or change a medication (for more than 15 days in a row) that is known to affect weight or blood sugar levels, such as thyroid hormones or steroid medications.
  • People who have difficulty recognising the warning signs of low blood sugar, as determined by the study doctor using a standard questionnaire.
  • People who have had repeated serious low blood sugar episodes in the past year, as assessed by the study doctor.

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.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Phone: (+1) 866-867-7178

Australian sites

Macquarie University - Clinical Trials Unit, Macquarie Park, New South Wales
Illawarra Diabetes Service Clinical Trials & Research Unit, Wollongong, New South Wales
Townsville University Hospital, Townsville, Queensland
Southern Adelaide Diabetes & Endocrine Services, Oaklands Park, South Australia
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department, Fitzroy, Victoria
Austin Health, Metabolic Disorders Centre, Heidelberg Heights, Victoria
The Royal Melbourne Hospital - Diabetes & Endocrinology Department, Parkville, Victoria

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
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
11 August 2025
Est. completion
25 January 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇪 Germany 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇸🇰 Slovakia 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in glycosylated haemoglobin (HbA1c)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 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.

View original record on ClinicalTrials.gov