Status:
RECRUITING
Precision Dosing of Metformin in Youth With T2D
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
10-21 years
Phase:
EARLY_PHASE1
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).
Detailed Description
Based on the investigators previous studies of young people who take metformin, the study team found that young people's bodies process metformin faster than older people and young people may need hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06120881
Start Date
April 25 2024
End Date
December 31 2026
Last Update
December 23 2025
Active Locations (2)
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1
UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
Oakland, California, United States, 94609
2
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
San Francisco, California, United States, 94158