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Precision Dosing of Metformin in Youth With Type 2 Diabetes

This study is looking at whether a higher dose of metformin, a common medication for Type 2 Diabetes (T2D), might work better for young people. Researchers believe that young people process metformin faster than adults, so they might need more of it. You would receive either the standard dose (2000mg/day) or a higher dose (2700mg/day) of metformin. The study will measure how acceptable and practical this higher dose is for participants. To join, you need to be between 10 and 21 years old, have T2D, and be taking regular metformin. This study is currently recruiting participants.

Study design
This interventional study plans to enroll 20 participants. It is a blinded study, meaning you won't know which dose of metformin you are receiving.
What's involved
You would need to wear a Continuous Glucose Monitor (CGM) for a total of 6 weeks during the study. Your medication regimen must be stable for 2 weeks before screening.
Compensation
Not stated in the trial record.
Follow-up
The main outcomes of the study will be measured at 3 months.

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NCT06120881

Precision Dosing of Metformin in Youth With T2D

Recruiting
EARLY_PHASE1Ages 10–21InterventionalTreatment
University of California, San Francisco
~20 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Metformin

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
Measured over Measured at 3 months
+1 more outcome measured

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Shylaja Srinivasan, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Avani A Narayan, MS
[email protected]
628-224-8364
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)Measured at 3 months

    The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability.

  • Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)Measured at 3 months

    The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility.