Precision Dosing of Metformin in Youth With T2D

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin

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.