Phase 3 Type 2 Diabetes Trial, Recruiting NCT07165223 Sponsor: Gan & Lee Pharmaceuticals. Condition: Type 2 Diabetes
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Phase 3 Type 2 Diabetes Trial, Recruiting

NCT07165223
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 are willing to sign a consent form, understand what the study involves including possible side effects, and agree to follow the study rules.
  • You are male or female and are 18 years of age or older.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test during the screening period and before being assigned to a treatment group.
  • If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must agree to use reliable contraception from the time you sign the consent form until 3 weeks after finishing treatment, and agree not to donate eggs or sperm during this time.
  • You have been diagnosed with type 2 diabetes for at least 180 days (about 6 months) before the screening visit, based on recognised World Health Organization guidelines.
  • Before the screening visit, you have been taking a long-acting (basal) insulin injection either once or twice a day, or a once-weekly insulin called Insulin Icodec.

Who may not be able to join:

  • You have a history of being allergic to medicines that work in two or more ways at once, or you are known to be allergic or intolerant to the study drug or any of its ingredients.
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have taken part in another clinical drug trial within the past 90 days (or longer, depending on the previous study drug), or you plan to join another clinical study before completing all parts of this one.
  • You have had a major heart or blood vessel procedure, a heart attack, stroke, severe chest pain, or another serious heart or circulation event in the 6 months before screening; or you have been diagnosed with severe long-term heart failure; or you plan to have a heart or artery procedure during the study; or your heart rhythm test (ECG) shows a significant problem that the study doctor thinks makes participation unsuitable (confirm with trial site).
  • You have had a diagnosis of cancer in the 5 years before screening, with some exceptions such as certain treated skin cancers or early-stage cervical or prostate cancer (confirm with trial site).
  • Your blood pressure reading at screening is too high — specifically, the top number is 160 or above, or the bottom number is 100 or above.
  • The study doctor decides for any reason that you are not suitable or able to follow the requirements of this 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.

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 28 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

Phone: 010-56456739

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
Gan & Lee Pharmaceuticals.
Registry
ClinicalTrials.gov
Start date
17 October 2025
Est. completion
10 November 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in 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: 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.

View original record on ClinicalTrials.gov