Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting NCT06559722 Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd Condition: Type 2 Diabetes
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Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting

NCT06559722
Not Yet Recruiting Phase 3

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 and have signed the consent form agreeing to participate.
  • Chinese adults aged 18 to 75 years (inclusive), male or female.
  • People who have been clinically diagnosed with type 2 diabetes for more than 6 months.
  • People whose HbA1c (a measure of average blood sugar levels over time) is between 7.0% and 10.0% (inclusive) at the screening blood test done by the trial's central laboratory.
  • People who have been taking metformin alone, or metformin combined with one other diabetes tablet (such as a sulfonylurea, glinide, alpha-glucosidase inhibitor, SGLT2 inhibitor, or TZD), for at least 90 days before screening, and who have been on a stable dose of that combination for at least 60 days before screening, at the doses specified by the trial (confirm with trial site).
  • People with a body mass index (BMI) between 19.0 and 40.0 kg/m² (inclusive).
  • People who are able and willing to follow the trial procedures, including checking and recording their own blood sugar levels, keeping a trial diary, and using the pre-filled injection pen device provided.

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 any type of diabetes other than type 2 diabetes.
  • People with a known or suspected allergy to the trial medication or any of its ingredients.
  • People who have taken part in another clinical trial or received an experimental medicine or medical device within the 90 days before screening.
  • People who have used blood sugar-lowering medicines other than those listed in the inclusion requirements for more than 14 days in total in the 90 days before screening, or who used such medicines in the 30 days before screening in a way that could affect the trial results (as judged by the trial doctor).
  • People who have taken steroid medicines (by injection into a vein, muscle, or under the skin, or by mouth) for more than 14 days in total in the 90 days before screening, or who used such medicines in the 30 days before screening in a way that could affect the trial results (as judged by the trial doctor). Note: steroid medicines applied to the skin, eyes, nose, joints, or inhaled are not included in this restriction.
  • People who have used herbal or traditional Chinese medicine products intended to lower blood sugar for more than 14 days in total in the 90 days before screening, or who used such medicines in the 30 days before screening in a way that could affect the trial results (as judged by the trial doctor).
  • People who have been on a regular insulin regimen (other than short-term use of 14 days or less in a row), or who used insulin in the 30 days before screening in a way that could affect the trial results (as judged by the trial doctor).
  • People who have used GLP-1 receptor agonist or DPP-4 inhibitor diabetes medicines within 90 days before screening (confirm with trial site if unsure which medicines these are).
  • People with reduced liver function, defined by specific blood test results showing liver enzyme or bilirubin levels above certain thresholds (confirm with trial site).
  • People with triglyceride (a type of blood fat) levels above 5.6 mmol/L at screening.
  • People with reduced kidney function, where the kidney filtration rate calculated by a standard formula is below 60 mL/min.
  • People who have had one or more severe low blood sugar episodes in the 6 months before screening.
  • People who have had one or more serious diabetes-related emergencies (such as diabetic ketoacidosis, hyperosmolar hyperglycaemic state, or diabetic lactic acidosis) in the 6 months before screening.
  • People who have other significant health conditions at the time of screening that may affect the trial results, including conditions affecting the heart, blood vessels, brain, lungs, digestive system, liver, kidneys, nervous system, mental health, blood, immune system, hormonal system, pancreas, or any cancer.

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

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 October 2025

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.

Primary endpoints

Change from baseline in HbA1c after 26 weeks of treatment

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