Precision Dosing of Metformin in Youth With T2D (PRECISE_T2D)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Early Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06120881

K23DK120932 (U.S. NIH Grant/Contract)

23-39745

Details and patient eligibility

About

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).

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups

Experimental

Experimental group

Description:

1350mg metformin twice per day

Treatment:

Drug: Metformin

Active Comparator

Active Comparator group

Description:

1000mg metformin twice per day

Treatment:

Drug: Metformin