Precision Dosing of Metformin in Youth With T2D

Type 2 Diabetes Clinical Trial

— PRECISE_T2D  

Official title:

Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120881
• Other study ID #: 23-39745
• Secondary ID: K23DK120932
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Avani A Narayan, MS
• Phone: 628-224-8364
• Email: avani.narayan[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

Inclusion 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. 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:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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 .

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Baseline (0) to 3 months
Secondary	Time in target glucose range	Time spent in target glucose range of 70 to 180 mg/dL	Baseline (0) to 3 months
Secondary	Time above high glucose range	Percent of readings and time >250 mg/dL	Baseline (0) to 3 months
Secondary	Time above glucose range	Percent of readings and time 181-250 mg/dL	Baseline (0) to 3 months
Secondary	Time in glucose range	Percent of readings and time 70-180 mg/dL	Baseline (0) to 3 months
Secondary	Time below glucose range	Percent of readings and time 54-69 mg/dL	Baseline (0) to 3 months
Secondary	Time below low glucose range	Percent of readings and time <54 mg/dl	Baseline (0) to 3 months
Secondary	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.	Baseline (0) to 3 months
Secondary	Co-efficient of variation of glucose	CGM metric that measures variability in CGM values	Baseline (0) to 3 months