Printed from Voxsanity (voxsanity.com.au) — NCT07619833 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Type 2 Diabetes
Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07619833
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 and able to take part in the study, understand what it involves, and are able to sign a consent form before any assessments begin.
- Adults aged 18 to 80 years (note: in Korea the minimum age is 19; in Indonesia it is 18).
- People who have been diagnosed with type 2 diabetes, based on American Diabetes Association (ADA) 2025 guidelines, before the screening visit.
- People who meet one of the following blood sugar control conditions at the first screening visit: either a specific blood marker for long-term blood sugar control (HbA1c) between 7.5% and 11%, and who have never taken diabetes tablets or have not taken any within the past 12 weeks — or an HbA1c between 6.5% and 10.5% and are currently taking one type of diabetes tablet.
- People whose fasting blood sugar level is below 15 mmol/L (270 mg/dL) at the screening visit, as measured by a local laboratory.
- People who, at a follow-up baseline visit, have an HbA1c between 7.5% and 11% and a fasting blood sugar below 15 mmol/L (270 mg/dL), as confirmed by a central laboratory.
- People with a body mass index (BMI) between 20 and 45 kg/m² at screening.
- Women who could become pregnant must have a negative pregnancy test at screening, and must agree to use highly effective contraception throughout the study and for at least 4 weeks after the last dose of study medication, and must not plan to become pregnant during this time.
- Male participants must agree to use highly effective contraception and not donate sperm throughout the study and for at least 4 weeks after the last dose of study medication.
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 with type 1 diabetes, congenital diabetes, diabetes caused by another condition, or a history of diabetic ketoacidosis, diabetic coma, or near-coma.
- People with serious diabetes-related complications, such as advanced eye disease affecting the retina, advanced kidney disease, or severe nerve damage related to diabetes.
- People with significant kidney disease, severe digestive system disease or surgery that affects how the body absorbs food, pancreatitis (inflammation of the pancreas), significant urinary or genital infections, dehydration needing treatment, or uncontrolled thyroid disease.
- People who have had a significant heart or stroke-related event within 6 months before screening, including heart attack, unstable chest pain, stroke, a serious heart rhythm problem needing treatment, or severe heart failure (classified as NYHA class III or IV).
- People with an active or untreated cancer, or a significant cancer diagnosis within the past 5 years (with exceptions for certain treated skin cancers or very early-stage cancers, as determined by the trial site).
- People with blood conditions that could interfere with the accuracy of the HbA1c blood test.
- People with significant hormone-related disorders that affect blood sugar levels.
- People with a known or suspected allergy or sensitivity to the study medication or related products.
- People with certain abnormal results on screening blood tests, including: a low level of a protein that indicates insulin production (fasting C-peptide at or below 0.60 ng/mL); very high triglyceride (blood fat) levels above 500 mg/dL; reduced kidney filtering function (eGFR below 60 mL/min/1.73m²); or elevated liver enzyme or bilirubin levels above certain thresholds.
- People who test positive for hepatitis B, hepatitis C, or HIV in ways that meet the study's specific criteria (confirm with trial site).
- People with uncontrolled high blood pressure (systolic pressure above 180 mmHg and/or diastolic pressure above 110 mmHg).
- People who have previously used certain diabetes medications, including: any combination diabetes tablet therapy; a medication class called thiazolidinediones within 12 weeks before screening; or GLP-1 receptor agonists or insulin within 6 months before screening.
- People who have used weight-loss medications within 3 months before screening, or between screening and the baseline visit.
- People who have used steroid medications (taken internally, not topically) at treatment-level doses within 1 month before screening, or between screening and the baseline visit.
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.
Contact this trial
Phone: 82-2-550-8016
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 3
Sponsor
Daewoong Pharmaceutical Co. LTD.
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 November 2027
Where this trial is recruiting
🇰🇷 South Korea
Primary endpoints
Change in HbA1c at Week 24 from Baseline after Randomization
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.