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Biguanide

Digital + Metformin for Prediabetes

Q: What demographic is eligible to join the experimental program?

This research project is looking for 41 individuals aged 18-44 years old who are part of the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified as prediabetic based on hemoglobin A1c (HbA1c). To fulfill NIH regulations, participants will be recruited across various genders and ethnicities regardless of age or background.

Q: Are there any other investigations that have scrutinized Metformin?

Currently, 191 sites are running 171 clinical trials for Metformin around the world. Out of those studies, 43 have progressed to Phase 3 and a majority of them are located in Pittsburgh, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: How many participants have been given access to this trial?

Affirmative. Data hosted on clinicaltrials.gov indicates that this trial, which was published on March 2nd 2022, is actively recruiting candidates. The study requires 41 participants and will be conducted at a single site.

Q: Has the Federal Drug Administration greenlighted Metformin?

Our scientists at Power have rated Metformin's safety a 2 due to the current Phase 2 trial, which has only furnished evidence of its security and not efficacy.

Q: In what ways is Metformin regularly applied therapeutically?

Metformin can be used to manage a variety of conditions, with physical activity being one such example. Other illnesses that may respond well to Metformin include <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> mellitus, diabetic ketoacidosis and dietary adjustment.

Q: Is this research open to those who have reached their senior years?

According to the study's eligibility parameters, only individuals aged between 18 and 44 can be accepted into this clinical trial.

Q: Is there an ongoing recruitment period for this clinical trial?

According to clinicaltrials.gov, this research is currently recruiting test subjects; the initial post date was March 2nd 2022 and it has been revised as recently as September 27th of the same year.

Phase 2

Recruiting

Led By Stephanie Dixon, MD, MPH

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 and <45 years of age

Investigators will recruit to enroll 55 survivors who are at least 18 but <45 years of age who participate in the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified to have prediabetes defined as hemoglobin A1c (HbA1c)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will establish the feasibility and safety of a combined pharmacologic and lifestyle intervention to prevent diabetes in prediabetic adult survivors of childhood cancer.

Who is the study for?

Adult survivors of childhood cancer aged 18-45 with prediabetes, part of the St. Jude Lifetime Cohort Study (SJLIFE), can join this trial. They must have a fasting plasma glucose level between 105-125 mg/dL or an HbA1c between 5.7-6.4%. Exclusions include severe health conditions like heart disease, kidney failure, liver dysfunction, and cognitive impairment.Check my eligibility

What is being tested?

The trial is testing if metformin combined with a digital lifestyle intervention can prevent diabetes in adults who had cancer as children and now have prediabetes. It's a single-arm study lasting for 24 weeks where participants first try lifestyle changes alone then add metformin.See study design

What are the potential side effects?

Possible side effects from metformin may include digestive issues like nausea or diarrhea, potential vitamin B12 deficiency over time, and rarely lactic acidosis—a serious metabolic complication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 45 years old.

Select...

I am 18-44 years old, part of the SJLIFE study, and have been diagnosed with prediabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence for feasibility

Digitally-delivered core education curriculum through the lifestyle change platform

Drug adherence/Pill Counts

+1 more

Secondary outcome measures

Glycemic Control

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Squamous cell carcinoma of the tongue

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Digital Intervention

2021

N/A

~180

Metformin

2006

Completed Phase 4

~2430

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,799 Total Patients Enrolled

St. Baldrick's FoundationOTHER

18 Previous Clinical Trials

9,038 Total Patients Enrolled

Conquer Cancer FoundationOTHER

19 Previous Clinical Trials

3,920 Total Patients Enrolled

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT04742751 — Phase 2

Prediabetes Research Study Groups: Treatment

Prediabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04742751 — Phase 2

Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742751 — Phase 2

Frequently Asked Questions

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

What demographic is eligible to join the experimental program?

"This research project is looking for 41 individuals aged 18-44 years old who are part of the St. Jude Lifetime Cohort Study (SJLIFE) and have been identified as prediabetic based on hemoglobin A1c (HbA1c). To fulfill NIH regulations, participants will be recruited across various genders and ethnicities regardless of age or background."

Answered by AI

Are there any other investigations that have scrutinized Metformin?

"Currently, 191 sites are running 171 clinical trials for Metformin around the world. Out of those studies, 43 have progressed to Phase 3 and a majority of them are located in Pittsburgh, Pennsylvania."

Answered by AI

How many participants have been given access to this trial?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this trial, which was published on March 2nd 2022, is actively recruiting candidates. The study requires 41 participants and will be conducted at a single site."

Answered by AI

Has the Federal Drug Administration greenlighted Metformin?

"Our scientists at Power have rated Metformin's safety a 2 due to the current Phase 2 trial, which has only furnished evidence of its security and not efficacy."

Answered by AI

In what ways is Metformin regularly applied therapeutically?

"Metformin can be used to manage a variety of conditions, with physical activity being one such example. Other illnesses that may respond well to Metformin include type 1 diabetes mellitus, diabetic ketoacidosis and dietary adjustment."

Answered by AI

Is this research open to those who have reached their senior years?

"According to the study's eligibility parameters, only individuals aged between 18 and 44 can be accepted into this clinical trial."

Answered by AI

Is there an ongoing recruitment period for this clinical trial?

"According to clinicaltrials.gov, this research is currently recruiting test subjects; the initial post date was March 2nd 2022 and it has been revised as recently as September 27th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

2022. "An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04742751.

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