Type 2 DiabetesEarly Phase 1PRECISE_T2DNCT06120881
Precision Dosing of Metformin in Youth With T2D
A Early Phase 1 study testing Metformin in people with Type 2 Diabetes, run by University of California, San Francisco at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic
Oakland, California, 94609
Shylaja Srinivasan, MD, 415-353-9084, Shylaja.Srinivasan@ucsf.edu
Laura A Dapkus AD Humphries, NCPT, 628-224-8364, Laura.Dapkus@ucsf.edu
- Recruiting
UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158
Shylaja A Srinivasan, MD, 415-353-9084, Shylaja.Srinivasan@ucsf.edu
Laura A Dapkus Humphries, NCPT, 628-224-8364, Laura.Dapkus@ucsf.edu
About this study
Official title: Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
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).
Read the detailed description
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).
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin
- Keywords
- Type 2 Diabetes, metformin, pediatric
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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 .
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 1350mg metformin twice per day Receives: Drug: Metformin |
| Active Comparator | Active comparator | 1000mg metformin twice per day Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measured at 3 months
Secondary outcomes (9)
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
Measured: Baseline (0) to 3 months
Time in target glucose range
Time spent in target glucose range of 70 to 180 mg/dL
Measured: Baseline (0) to 3 months
Time above high glucose range
Percent of readings and time >250 mg/dL
Measured: Baseline (0) to 3 months
Time above glucose range
Percent of readings and time 181-250 mg/dL
Measured: Baseline (0) to 3 months
Time in glucose range
Percent of readings and time 70-180 mg/dL
Measured: Baseline (0) to 3 months
Time below glucose range
Percent of readings and time 54-69 mg/dL
Measured: Baseline (0) to 3 months
Time below low glucose range
Percent of readings and time <54 mg/dl
Measured: 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.
Measured: Baseline (0) to 3 months
Co-efficient of variation of glucose
CGM metric that measures variability in CGM values
Measured: Baseline (0) to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shylaja Srinivasan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120881
- Sponsor's protocol ID
- 23-39745
- Other IDs
- K23DK120932
- Acronym
- PRECISE_T2D
- Status last verified
- Dec 2025
- First submitted
- 1 Nov 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)
- ClinicalTrials.gov ID
- NCT06120881
- Acronym / sponsor ID
- PRECISE_T2D / 23-39745
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, metformin, pediatric
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Metformin1350mg metformin twice per day |
| Active Comparator | Active comparator | Drug: Metformin1000mg metformin twice per day |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants 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 . | Drug | Active Comparator, Experimental |
Primary outcome
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
Time frame: Measured at 3 months
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.
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
Time frame: Measured at 3 months
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.
9 secondary outcomes
Glycemic Change
Time frame: Baseline (0) to 3 months
Time in target glucose range
Time frame: Baseline (0) to 3 months
Time above high glucose range
Time frame: Baseline (0) to 3 months
Time above glucose range
Time frame: Baseline (0) to 3 months
Time in glucose range
Time frame: Baseline (0) to 3 months
Time below glucose range
Time frame: Baseline (0) to 3 months
Time below low glucose range
Time frame: Baseline (0) to 3 months
Glucose management indicator
Time frame: Baseline (0) to 3 months
Co-efficient of variation of glucose
Time frame: Baseline (0) to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shylaja Srinivasan, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Type 2 Diabetes, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avani A Narayan, MS (628-224-8364, avani.narayan@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM) (time frame: Measured at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.