Type 2 Diabetes study: Metformin
Official title Precision Dosing of Metformin in Youth With T2D
ClinicalTrials.gov ID: NCT06120881
What this study is testing
What is Metformin?
Metformin is an investigational medicine, taken by mouth twice daily, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a higher dose of metformin is more effective than the usual dose. It compares 1350mg twice a day with 1000mg twice a day in people with type 2 diabetes.
- Who it's for
- You may be able to join if you are a teen with type 2 diabetes.
- What's involved
- You would take metformin tablets twice a day. You will either get the usual dose or the higher dose. Your doctor will check your health.
- Time commitment
- The study lasts a few months and you will have regular check‑ins with your doctor.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 21. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Oakland, California, United States
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Oakland, California, United States; San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.