Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2024-04-25
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
1350mg metformin twice per day
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 .
Active Comparator
1000mg metformin twice per day
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 .
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
21 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Shylaja Srinivasan, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
Oakland, California, United States
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Shylaja Srinivasan, MD
Role: primary
Laura A Dapkus AD Humphries, NCPT
Role: backup
Shylaja A Srinivasan, MD
Role: primary
Laura A Dapkus Humphries, NCPT
Role: backup
Other Identifiers
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23-39745
Identifier Type: -
Identifier Source: org_study_id