Recruiting
Precision Dosing of Metformin in Youth With T2D
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).
ClinicalTrials.gov IDNCT06120881
PhaseEARLY_PHASE1
Enrollment20
SponsorUniversity of California, San Francisco
Age10 Years
SexALL
Conditions studied
Type 2 Diabetes
About this study
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).
Interventions
- Drug: Metformin — Participants will receive either 2700mg of metformin/day (1350mg twice a day) or 2000mg of metformin/day (1000mg twice a day, standard of care). The study intervention will be blinded to the participants as they will receive the same number of pills (4 pills of the same size) regardless of whether they are in the intervention arm or control arm .
Primary outcomes
- Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) (Measured at 3 months)
- Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM) (Measured at 3 months)
Eligibility information
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.
Study locations
- UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic, Oakland, California 94609 United States
- UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes, San Francisco, California 94158 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.