Precision Dosing of Metformin in Youth With T2D
Recruiting · NCT06120881 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
10 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic - Oakland, California, United States
- UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes - San Francisco, California, United States