NCT06120881

Precision Dosing of Metformin in Youth With T2D

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Accepted

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).

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2024-04-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-11-07
• Last updated: 2025-12-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study