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Anti-diabetic agent

Metformin for Prediabetes

Phase 2

Waitlist Available

Led By Diana I Jalal, MD

Research Sponsored by Diana Jalal

Eligibility Criteria Checklist

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

Must have

Age 18-55 years

Be between 18 and 65 years old

Must not have

History of diabetes, myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate < 45 ml/min/1.73m2)

Current use of medicated contraindicated for use with metformin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial aims to see if metformin can improve blood vessel function in people with prediabetes. Participants will take metformin or a placebo for 12 weeks and researchers will compare the effects

Who is the study for?

This trial is for individuals with prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should not have started any new cardiovascular or glucose-lowering medications within the last three months.

What is being tested?

The study tests if metformin, a common diabetes medication, can improve blood vessel function in people with prediabetes. It compares the effects of metformin against a placebo over 12 weeks, with doses increasing after the first two weeks.

What are the potential side effects?

Possible side effects of metformin include digestive issues like nausea and diarrhea, potential vitamin B12 deficiency with long-term use, and very rarely, an increased risk of lactic acidosis.

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 55 years old.

Exclusion Criteria

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

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I have a history of diabetes, heart issues, liver disease, or severe kidney disease.

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I am not taking any medications that can't be used with metformin.

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I have taken metformin in the last year.

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My BMI is over 40.

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I have not had a severe infection in the last 30 days.

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I am currently smoking or quit less than 6 months ago.

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I have had lactic acidosis in the past.

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I have not taken immunosuppressive drugs in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Macrovascular endothelial function

Secondary study objectives

Microvascular endothelial function

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MetforminExperimental Treatment1 Intervention

Participants will receive metformin 850 mg PO once a day for 2 weeks. After 2 weeks, participants will receive metformin 1700 mg PO once a day for the remaining 10 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive placebo pill identical in appearance and taste to the supplement

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 9Eligibility criteria met