Phase 3 Type 2 Diabetes Trial, Recruiting NCT07083154 Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Condition: Type 2 Diabetes
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Phase 3 Type 2 Diabetes Trial, Recruiting

NCT07083154
Recruiting Phase 3

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:

  • You have been diagnosed with Type 2 diabetes.
  • You are between 50 and 75 years old (men and women can both apply).
  • You have early-stage memory or thinking problems, described as mild cognitive impairment or mild dementia, based on specific memory test scores (confirm with trial site).
  • You have been noticing memory problems yourself for at least 6 months.
  • Your diabetes management (whether through diet alone, diabetes tablets, or once-daily long-acting insulin) has been stable for at least 3 months before joining.
  • Your blood sugar control (measured by a test called HbA1c) is between 7.0% and 9.0%.
  • Your body weight is within a healthy range (BMI of 20 or above) and has been stable for at least 3 months.
  • Any treatment you receive for memory or thinking problems has been stable for at least 3 months, and you are willing to keep it the same throughout the study — this includes having no treatment, non-drug approaches like brain training, or approved memory medications (but not newer Alzheimer's disease-modifying drugs).
  • You are able to take part in regular memory and daily functioning tests throughout the study.
  • You fully understand what the trial involves and are willing to sign a consent form and follow all study requirements.

Who may not be able to join:

  • You have been diagnosed with another brain condition that affects memory, such as Parkinson's disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, multiple sclerosis, or similar conditions.
  • You currently have a poorly controlled or unstable mental health condition (such as schizophrenia, bipolar disorder, severe depression, or severe anxiety) that the study doctor believes could affect your participation or safety.
  • Your score on a standard depression or anxiety questionnaire at the screening appointment is at or above a certain threshold (confirm with trial site).
  • You have had a stroke, mini-stroke (TIA), or epileptic seizure in the 3 months before joining, or you have a current or past brain condition such as a brain infection, brain tumour, or severe head injury that may affect your thinking.
  • You have had a serious diabetes emergency in the past year, such as diabetic ketoacidosis, a dangerous high blood sugar crisis, or a coma caused by low blood sugar.
  • You have used certain diabetes medications called GLP-1 receptor agonists or related drugs in the 3 months before joining (confirm with trial site for specific drug names).
  • You regularly use certain medications that can affect the nervous system or brain, including strong anticholinergic drugs, anti-Parkinson's drugs, anti-epileptic drugs, antipsychotics, or opioid painkillers within specific timeframes before joining (confirm with trial site for exact details).
  • You have used cannabis or cannabis-related products (including CBD) recreationally or medically within 4 weeks before joining.
  • You drink more alcohol than 21 units per week (if male) or 14 units per week (if female).
  • You have a medical history of thyroid cancer (a specific type called medullary thyroid carcinoma), pancreatitis, a condition called MEN2, gallbladder or serious bowel disease, or currently have an active cancer.
  • You have uncontrolled or unstable diabetic eye disease.
  • You have serious problems with your liver, kidneys, or heart (including a recent heart attack or significant heart failure within 3 months).
  • You are known to be allergic or sensitive to the study drug or similar substances.
  • You are pregnant, breastfeeding, or able to become pregnant and not using reliable contraception.
  • You are unable to have an MRI scan, for example because of metal implants in your body or severe claustrophobia.
  • You have taken part in another clinical drug trial within the past 3 months.
  • You have any other health condition that the study doctor believes could put you at risk or affect the study results.

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 13 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: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Phone: 6-25-83-105302.

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
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Registry
ClinicalTrials.gov
Start date
27 September 2025
Est. completion
1 August 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change

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: 13 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