Precision Dosing of Metformin in Youth With T2D

NCT06120881 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 23-39745K23DK120932
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; metformin; pediatric

Outcome Measures

Primary Outcomes (2)

• 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 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 at 3 months

Secondary Outcomes (9)

• Glycemic Change

  Baseline (0) to 3 months

• Time in target glucose range

  Baseline (0) to 3 months

• Time above high glucose range

  Baseline (0) to 3 months

• Time above glucose range

  Baseline (0) to 3 months

• Time in glucose range

  Baseline (0) to 3 months

Study Arms (2)

Experimental

EXPERIMENTAL

1350mg metformin twice per day

Drug: Metformin

Active Comparator

ACTIVE COMPARATOR

1000mg metformin twice per day

Drug: Metformin

Interventions

Metformin DRUG

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; Experimental

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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)
• 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.

You may not qualify 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic

Oakland, California, 94609, United States

RECRUITING

UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Shylaja Srinivasan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avani A Narayan, MS

CONTACT

628-224-8364; avani.narayan@ucsf.edu

Laura A. Dapkus Humphries, NCPT

CONTACT

628-224-8364; laura.dapkus@ucsf.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)