Recruiting

Early Phase 1

MetforminPrecision Dosing of Metformin in Youth With T2D

Sponsor:

UCLA

Code:

NCT06120881

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

Interventions

Metformin

Study Details

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).

Conditions

Type 2 Diabetes

Study ID

NCT06120881

Start date

Apr 25, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

1350mg metformin twice per day

active comparator: Active Comparator

1000mg metformin twice per day

Interventions

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 outcome measure

Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) [ Time Frame: Measured at 3 months ]
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM) [ Time Frame: Measured at 3 months ]

Central Contacts and Locations

Central contacts

Avani A Narayan, MS

628-224-8364 avani.narayan@ucsf.edu

Laura A. Dapkus Humphries, NCPT

628-224-8364 laura.dapkus@ucsf.edu

Locations

UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic

Recruiting

Oakland, California, United States, 94609

Contacts

Shylaja Srinivasan, MD

415-353-9084 Shylaja.Srinivasan@ucsf.edu

Laura A Dapkus AD Humphries, NCPT

628-224-8364 Laura.Dapkus@ucsf.edu

Principal Investigator:

Shylaja Srinivasan, MD

UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes

Recruiting

San Francisco, California, United States, 94158

Contacts

Shylaja A Srinivasan, MD

415-353-9084 Shylaja.Srinivasan@ucsf.edu

Laura A Dapkus Humphries, NCPT

628-224-8364 Laura.Dapkus@ucsf.edu

Principal Investigator:

Shylaja Srinivasan, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

Type 2 Diabetes
metformin
pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-12-23.