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Anti-diabetic agent

High-Dose Metformin for Type 2 Diabetes (PRECISE_T2D Trial)

Phase < 1
Recruiting
Led By Shylaja Srinivasan, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Provider diagnosis of T2D
Taking regular metformin (not extended-release formula)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 months
Awards & highlights

PRECISE_T2D Trial Summary

This trial tests if a higher dose of metformin works better than standard dose to treat diabetes.

Who is the study for?
This trial is for young people aged 8-21 with Type 2 Diabetes who speak English or Spanish. They must be able to wear a CGM device for 6 weeks, have been on a stable medication regimen for at least two weeks, and take regular metformin. Those with significant mental illness, ongoing renal or hepatic disease, or pancreatic autoantibody positivity cannot participate.Check my eligibility
What is being tested?
The study is testing the effects of two different doses of metformin in youth with Type 2 Diabetes: the standard dose (1000mg twice daily) versus a higher dose (1350mg twice daily). Participants will compare these dosages over the course of the study.See study design
What are the potential side effects?
Metformin can cause side effects like stomach upset, diarrhea, nausea and vomiting, gas, weakness, headache, muscle pain and low blood sugar levels. The risk may increase slightly with higher doses.

PRECISE_T2D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with type 2 diabetes.
Select...
I am currently taking standard metformin.
Select...
I am between 8 and 21 years old.

PRECISE_T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM)
Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM)
Secondary outcome measures
Co-efficient of variation of glucose
Glucose management indicator
Glycemic Change
+6 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

PRECISE_T2D Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
1350mg metformin twice per day
Group II: Active ComparatorActive Control1 Intervention
1000mg metformin twice per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,555 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,572 Total Patients Enrolled
Shylaja Srinivasan, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period of this trial ongoing?

"As per the clinicaltrials.gov records, this medical trial is not presently enrolling patients. The first posting was on December 1st 2023 and has since been modified as of November 1st 2023. Despite its current state, there are 880 other studies actively recruiting participants at the moment."

Answered by AI

Is my participation in this clinical trial feasible?

"This clinical research is only open to patients between 8 and 21 years of age who possess type 2 diabetes. The total number of participants accepted in this trial will be 20 individuals."

Answered by AI

What aims does this clinical experiment aspire to accomplish?

"The primary measure of the trial, monitored over a 3 month period, is the Feasibility of Higher Metformin Dose as evaluated by the Feasibility Intervention Measure (FIM). Secondary metrics include Time in target glucose range (70-180 mg/dL), Percent readings and time above high glucose range (>250 mg/dL) and Percent readings and time within moderate sugar levels (181-250 mg/dL)."

Answered by AI

Do people over sixty years of age qualify for participation in this trial?

"The minimum age for participation in this study is 8 years, while the maximum permissible age is 21."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Precision Dosing of Metformin in Youth With T2D
2024. "Precision Dosing of Metformin in Youth With T2D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120881.
~13 spots leftby Dec 2024
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