An Early Phase 1 interventional study of Metformin in Type 2 Diabetes, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to participants aged 10 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University of California, San Francisco · Early Phase 1, Interventional, and Treatment
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).
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).
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1350mg metformin twice per day
Drug: Metformin
1000mg metformin twice per day
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 .
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability.
Time frame: Measured at 3 months
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility.
Time frame: Measured at 3 months
Glycemic Change
Change in serum HbA1C at 3 months adjusted for the baseline value youth with T2D on higher dose of metformin compared to standard dose
Time frame: Baseline (0) to 3 months
Time in target glucose range
Time spent in target glucose range of 70 to 180 mg/dL
Time frame: Baseline (0) to 3 months
Time above high glucose range
Percent of readings and time \>250 mg/dL
Time frame: Baseline (0) to 3 months
Time above glucose range
Percent of readings and time 181-250 mg/dL
Time frame: Baseline (0) to 3 months
Time in glucose range
Percent of readings and time 70-180 mg/dL
Time frame: Baseline (0) to 3 months
Time below glucose range
Percent of readings and time 54-69 mg/dL
Time frame: Baseline (0) to 3 months
Time below low glucose range
Percent of readings and time \<54 mg/dl
Time frame: Baseline (0) to 3 months
Glucose management indicator
Continuous glucose monitoring (CGM) metric that indicates average blood glucose. Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using CGM values. Average glucose is derived from 14 or more days of CGM readings.
Time frame: Baseline (0) to 3 months
Co-efficient of variation of glucose
CGM metric that measures variability in CGM values
Time frame: Baseline (0) to 3 months
Plan to share: No
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University of California, San Francisco