Phase 1 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

All participants must meet these criteria:

• A signed consent form must be completed before any study-related activities begin
• Participants must be male or female (based on sex at birth) and not able to become pregnant
• Participants must be between 18 and 64 years old at the time of signing the consent form

Healthy participants must also meet these criteria:

• Body weight relative to height (BMI) must be between 18.5 and 29.9 at the screening visit
• A blood sugar marker called HbA1c must be 6.4% or below at screening
• The participant must be considered generally healthy based on medical history, physical checks, and test results, as determined by the study doctor

Participants with Type 2 Diabetes must also meet these criteria:

• BMI must be between 20.0 and 34.9 at the screening visit
• HbA1c must be between 6.5% and 9.0% at screening
• A diagnosis of Type 2 Diabetes must have been made at least 180 days before screening
• Participants must have been on a stable daily dose of metformin, or metformin combined with certain other diabetes medications (DPP-4 inhibitors and/or SGLT-2 inhibitors), for at least 90 days before screening

Who may not be able to join:

All participants:

• Liver blood test results that are above the accepted normal range at screening
• Reduced kidney function, based on a specific kidney measurement falling below a set threshold at screening
• Signs or history of chronic kidney disease, or a urine test showing protein levels above a certain limit
• Any history or current diagnosis of heart-related conditions, including chest pain, heart attack, mini-stroke, stroke, heart failure, or significant heart rhythm or electrical problems

Healthy participants:

• Any health condition that the study doctor believes could put the participant at risk or affect their ability to follow the study requirements
• Blood pressure readings at screening that fall outside the ranges of 90–139 (top number) or 50–89 (bottom number) mmHg while lying down

Participants with Type 2 Diabetes:

• Any health condition beyond mild, stable conditions linked to Type 2 Diabetes that the study doctor believes could affect safety or ability to follow the study requirements
• Blood pressure readings at screening that fall outside the ranges of 90–159 (top number) or 50–99 (bottom number) mmHg while lying down, including those already taking blood pressure medication

Important: Always verify eligibility with the trial site directly before applying.