Precision Dosing of Metformin in Youth With T2D

Last updated: March 25, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Metformin

Clinical Study ID

NCT06120881
23-39745
K23DK120932
  • Ages 10-21
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age 10-21 years

  • Provider diagnosis of T2D

  • Stable medication regimen for 2 weeks before screening visit (No addition or removalof 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 orguardian willing and able to sign the ICF.

  • Participant and parent(s)/guardian(s) willingness to participate in all trainingsessions as directed by study staff. Written informed consent (and assent whenapplicable) obtained from subject or subject's legal representative and ability forsubject to comply with the requirements of the study.

Exclusion

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 theability to complete study activities independently.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Metformin
Phase: 1
Study Start date:
April 25, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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).

Connect with a study center

  • UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic

    Oakland, California 94609
    United States

    Active - Recruiting

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

    San Francisco, California 94158
    United States

    Active - Recruiting

  • UCSF Madison Clinic for Pediatric Diabetes

    San Francisco, California 94158
    United States

    Site Not Available

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