RecruitingEarly Phase 1NCT06120881

Precision Dosing of Metformin in Youth With T2D

Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)

Sponsor

University of California, San Francisco

Enrollment

20 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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

Min Age: 10 YearsMax Age: 21 Years

Inclusion Criteria10

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 Criteria3

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.

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 .