Comparing metformin doses for youth with Type 2 Diabetes
Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
This study is testing whether a higher dose of metformin can help young people with Type 2 Diabetes manage their blood sugar better than the standard dose.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (Oakland, California and 1 other locations) |
| Trial ID | NCT06120881 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a higher dose of metformin (1350mg twice a day) compared to the standard dose (1000mg twice a day) in young individuals diagnosed with Type 2 Diabetes. Previous research suggests that younger patients metabolize metformin more quickly, potentially requiring higher doses for optimal treatment outcomes. Participants aged 10-21 years will be monitored while taking metformin and using continuous glucose monitoring (CGM) for six weeks. The study will assess the impact of the dosing on glycemic control and overall health.
Who should consider this trial
Good fit: Ideal candidates are youth aged 10-21 years with a provider diagnosis of Type 2 Diabetes who are currently taking regular metformin.
Not a fit: Patients with pancreatic autoantibody positivity or those with a known history of certain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for young patients with Type 2 Diabetes by optimizing metformin dosing.
How similar studies have performed: Other studies have indicated that adjusting metformin doses based on age and metabolism may enhance treatment efficacy, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oakland, California and 1 other locations
- UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic — Oakland, California, United States (Recruiting)
- UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Shylaja Srinivasan, MD — University of California, San Francisco
- Study coordinator: Avani A Narayan, MS
- Email: avani.narayan@ucsf.edu
- Phone: 628-224-8364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.