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Recruiting NCT06120881

Precision Dosing of Metformin in Youth With T2D

Early Phase I Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 10 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed 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).

Interventions

  • Drug 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 measures

  • 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]
Secondary outcome measures (9)
  • Glycemic Change [Time frame: Baseline (0) to 3 months]
  • Time in target glucose range [Time frame: Baseline (0) to 3 months]
  • Time above high glucose range [Time frame: Baseline (0) to 3 months]
  • Time above glucose range [Time frame: Baseline (0) to 3 months]
  • Time in glucose range [Time frame: Baseline (0) to 3 months]
  • Time below glucose range [Time frame: Baseline (0) to 3 months]
  • Time below low glucose range [Time frame: Baseline (0) to 3 months]
  • Glucose management indicator [Time frame: Baseline (0) to 3 months]
  • Co-efficient of variation of glucose [Time frame: Baseline (0) to 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic — Oakland
  • UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes — San Francisco

Identifiers

NCT: NCT06120881 · 23-39745 · K23DK120932

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗