Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
University of California, San Francisco
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).
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 higher doses of metformin for the best treatment outcomes. The purpose of this study is to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).
Eligibility
- Age range
- 10–21 years
- Sex
- All
- Healthy volunteers
- Yes
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 an…
Interventions
- DrugMetformin
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 .
Locations (2)
- UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes ClinicOakland, California
- UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric DiabetesSan Francisco, California