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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 21
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
RECRUITING
Oakland
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
RECRUITING
San Francisco
Contact Information
Primary
Avani A Narayan, MS
avani.narayan@ucsf.edu
628-224-8364
Backup
Laura A. Dapkus Humphries, NCPT
laura.dapkus@ucsf.edu
628-224-8364
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Experimental
1350mg metformin twice per day
Active_comparator: Active Comparator
1000mg metformin twice per day
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov