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Biguanide

Digital + Metformin for Prediabetes

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)

Must not have

Diagnosis of schizophrenia or other psychotic disorder

Chronic kidney disease ≥ stage IIIb (eGFR < 45 mL/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 18 and 45 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with schizophrenia or another psychotic disorder.

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My kidney function is reduced (eGFR < 45 mL/min).

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I am currently using medication to manage my diabetes.

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I need oxygen or use inhalers daily due to lung problems.

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I have diabetes with high blood sugar or HbA1c levels, or a doctor previously diagnosed me.

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I have vision problems that make it hard for me to use digital devices.

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I do not have severe heart problems or recent major heart treatments.

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I have lost more than 10% of my weight in the last 6 months.

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I do not speak English.

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I cannot swallow pills.

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My liver is not working well (I have cirrhosis or high liver enzyme levels).

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I am currently receiving treatment for active cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence for feasibility

Digitally-delivered core education curriculum through the lifestyle change platform

Drug adherence/Pill Counts

+1 more

Secondary study objectives

Glycemic Control

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Metformin

2006

Completed Phase 4

~2430

Digital Intervention

2021

N/A

~180