NCT06120881 Precision Dosing of Metformin in Youth With T2D
| NCT ID | NCT06120881 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, San Francisco |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-04-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
Eligibility Criteria
Inclusion Criteria: * Age 10-21 years * Provider diagnosis of T2D * Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose) * ≥ 1 month from T2D diagnosis * Taking regular metformin (not extended-release formula) * Ability to wear CGM for a total of 6 weeks while in the study. * English or Spanish speakers. * Willing to abide by recommendations and study procedures. * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. * Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8). * Known history of ongoing renal or hepatic disease. * Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
Contact & Investigator
Shylaja Srinivasan, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06120881 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06120881 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06120881 currently recruiting?
Yes, NCT06120881 is actively recruiting participants. Contact the research team at avani.narayan@ucsf.edu for enrollment information.
Where is the NCT06120881 trial being conducted?
This trial is being conducted at Oakland, United States, San Francisco, United States.
Who is sponsoring the NCT06120881 clinical trial?
NCT06120881 is sponsored by University of California, San Francisco. The principal investigator is Shylaja Srinivasan, MD at University of California, San Francisco. The trial plans to enroll 20 participants.
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