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NCT Number: NCT06120881

Precision Dosing of Metformin in Youth With T2D

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic, Oakland, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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 outcomes

  1. Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)

    Time frame: 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.

  2. Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)

    Time frame: 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.

Secondary outcomes

  1. Glycemic Change

    Time frame: Baseline (0) to 3 months

    Change in serum HbA1C at 3 months adjusted for the baseline value youth with T2D on higher dose of metformin compared to standard dose

  2. Time in target glucose range

    Time frame: Baseline (0) to 3 months

    Time spent in target glucose range of 70 to 180 mg/dL

  3. Time above high glucose range

    Time frame: Baseline (0) to 3 months

    Percent of readings and time >250 mg/dL

  4. Time above glucose range

    Time frame: Baseline (0) to 3 months

    Percent of readings and time 181-250 mg/dL

  5. Time in glucose range

    Time frame: Baseline (0) to 3 months

    Percent of readings and time 70-180 mg/dL

  6. Time below glucose range

    Time frame: Baseline (0) to 3 months

    Percent of readings and time 54-69 mg/dL

  7. Time below low glucose range

    Time frame: Baseline (0) to 3 months

    Percent of readings and time <54 mg/dl

  8. Glucose management indicator

    Time frame: Baseline (0) to 3 months

    Continuous glucose monitoring (CGM) metric that indicates average blood glucose.

    Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using CGM values. Average glucose is derived from 14 or more days of CGM readings.

  9. Co-efficient of variation of glucose

    Time frame: Baseline (0) to 3 months

    CGM metric that measures variability in CGM values

Study contacts

Contact information is provided by the study sponsor or research team.

Avani A Narayan, MS

CONTACT

[email protected]

628-224-8364

Laura A. Dapkus Humphries, NCPT

CONTACT

[email protected]

628-224-8364

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: PRECISE_T2D

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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