Phase 3 Type 1 Diabetes Trial, Recruiting NCT06334133 Sponsor: vTv Therapeutics Condition: Type 1 Diabetes
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Phase 3 Type 1 Diabetes Trial, Recruiting

NCT06334133
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:

  • Adults aged 18 or older
  • People who have been diagnosed with Type 1 diabetes for at least 3 years
  • People who have had at least one low blood sugar episode in the past 2 months — either a moderate low (blood sugar below 54 mg/dL or 3 mmol/L, confirmed by a monitor) or a severe low that caused confusion or physical problems and required help from another person
  • People whose HbA1c (a measure of average blood sugar over time) is below 9.5% at the screening appointment
  • People who have been using an insulin pump (but not a closed-loop/automated system) or multiple daily insulin injections for at least 6 months before screening, and who are willing to continue that same method throughout the study
  • People who have been using a continuous glucose monitor (CGM) for at least 3 months before screening

Who may not be able to join:

  • People who have Type 2 diabetes, a rare or unusual form of diabetes, or diabetes caused by another medical condition
  • People who were hospitalised for diabetic ketoacidosis (a serious diabetes complication) within the 3 months before screening
  • People with thyroid conditions that are not well controlled
  • People with a history of an eating disorder (such as anorexia, bulimia, or deliberately skipping insulin to control weight) within the past 2 years
  • People with an active cancer, an untreated cancer, or a cancer that has been in remission for 5 years or less — except for certain treated skin cancers or cervical cancer in situ
  • People who have used non-insulin diabetes medications (such as SGLT-2 inhibitors, GLP-1 medications, metformin, or others listed in the trial criteria) or weight-loss medications within the 30 days before screening
  • People who have used a hybrid closed-loop insulin system or a DIY looping system within the 30 days before screening, or who plan to start one during the study
  • People with significantly reduced kidney function, as measured by a specific kidney test (eGFR below 30 mL/min/1.73 m²) at screening (confirm with trial site)
  • People with high blood pressure that is not well controlled before screening

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 26 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: Thomas Strack, MD, vTv Therapeutics

Phone: (336) 888-0435

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
vTv Therapeutics
Registry
ClinicalTrials.gov
Start date
14 June 2024
Est. completion
1 September 2026

Where this trial is recruiting

Puerto Rico 🇺🇸 United States

Primary endpoints

Change in incidence of Level 2 or Level 3 hypoglycemia

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: 26 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