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Biguanide

Metformin for Aging (ANTHEM Trial)

Phase 3
Recruiting
Led By Adam Konopka, PhD
Research Sponsored by Oklahoma Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
40-75 years of age (inclusive)
Free of chronic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 weeks
Awards & highlights

ANTHEM Trial Summary

This trial is testing whether the drug metformin can help slow aging by improving insulin sensitivity and regulating glucose in the body. They will be testing this on 148 people, half of which will take metformin and half a placebo, over the course of 12 weeks.

Who is the study for?
This trial is for English-speaking adults aged 40-75 who are mobile, can be contacted by phone, and have no chronic diseases. They must understand the study's protocol and not have diabetes, cancer, heart or kidney disease, respiratory issues, Alzheimer's or use tobacco. Pregnant individuals or those with allergies to metformin/lidocaine cannot join.Check my eligibility
What is being tested?
The study tests if Metformin can slow aging by improving insulin sensitivity in insulin-resistant people without diabetes while assessing potential negative effects on insulin-sensitive participants. It involves a double-blind comparison of Metformin against a placebo over 12 weeks with pre- and post-intervention assessments.See study design
What are the potential side effects?
Potential side effects of Metformin include digestive upset (like nausea or diarrhea), headaches, muscle pain, low vitamin B12 levels which might cause anemia or nerve problems, and rarely lactic acidosis—a serious metabolic complication.

ANTHEM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 75 years old.
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I do not have any long-term illnesses.
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I can move around on my own.
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I am between 40 and 75 years old.
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I do not have any long-term illnesses.
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I can use a phone and be reached by one.
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I can move around on my own.

ANTHEM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in insulin sensitivity measure
Mean change in mitochondrial function of the electron transport system measured by complex I activity
Secondary outcome measures
Mean change in blood-based biomarker measures of aging
Mean change in daily average glucose measure

Side effects data

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

ANTHEM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
The investigators use a "ramp up" dosing protocol in which the amount of metformin (Hunter Pharmacy) will begin at 500 mg/day in week 1, increase to 1000 mg/day in week 2, and then to 1500 mg/day in week 3, as tolerated. At week 3 and for the remaining 9 weeks, the dose will remain at 1500 mg/day, which is a standard clinical dose (1500-2000 mg/day). If a subject has gastrointestinal discomfort with 1500 mg/day the dose, the investigators will lower the dose to 1000 mg/day. The investigators will split the dose with 1/2 given in the a.m. and 1/2 in the p.m. and taken with meals to minimize GI discomfort.
Group II: PlaceboPlacebo Group1 Intervention
Subjects assigned to the placebo group will receive visually identical pills (silicified microcrystalline cellulose, Micosolle®, K30 povidone, sodium starch glycolate, and magnesium stearate). The same dosing schedule will be followed as for metformin. The investigators use a "ramp up" dosing protocol in which the amount of placebo (Hunter Pharmacy) will begin at 500 mg/day in week 1, increase to 1000 mg/day in week 2, and then to 1500 mg/day in week 3, as tolerated. At week 3 and for the remaining 9 weeks, the dose will remain at 1500 mg/day. If a subject has gastrointestinal discomfort with 1500 mg/day the dose, the investigators will lower the dose to 1000 mg/day. The investigators will split the dose with 1/2 given in the a.m. and 1/2 in the p.m. and taken with meals to minimize GI discomfort.
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?

Oklahoma Medical Research FoundationLead Sponsor
21 Previous Clinical Trials
7,934 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,351 Total Patients Enrolled
2 Trials studying Insulin Sensitivity
91 Patients Enrolled for Insulin Sensitivity
University of OklahomaOTHER
455 Previous Clinical Trials
97,973 Total Patients Enrolled

Media Library

Insulin Sensitivity Patient Testimony for trial: Trial Name: NCT04264897 — Phase 3

Frequently Asked Questions

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

Does this research project allow people who are 60 or older to participate?

"The team is currently looking for participants who fall in the age range of 40 to 75 years old."

Answered by AI

Why is Metformin a popular choice among doctors?

"Metformin is most frequently used to treat type 2 diabetes, but it can also be effective in managing diabetic ketoacidosis, polycystic ovary syndrome, and other conditions."

Answered by AI

Can you tell us about other times Metformin has been used in research?

"There are one hundred and eighty (180) ongoing studies into Metformin. Forty-five (45) of those are in Phase 3. Most research teams for Metformin are based in Rockville, Maryland; however, there 1952 total locations running trials for this medication."

Answered by AI

Are we still able to welcome new participants into this research project?

"That is correct, the online clinicaltrials.gov registry reveals that this study is still ongoing and looking for participants. The first posting was on 29 July 2020 with the most recent edit taking place 16 November 2021. A total of 148 patients will be recruited from 2 sites."

Answered by AI

Are there specific characteristics that make a person eligible for this clinical trial?

"This trial is seeking 148 patients that are between 40 and 75 years old. To be eligible, potential participants must also have insulin resistance and meet the following additional requirements: comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form; ability to use and be contacted by telephone; ability to speak, read, and understand English; independently mobile."

Answered by AI

Has Metformin been cleared by the FDA?

"Metformin has been studied enough to support its efficacy, and there is also data that suggests it is safe for use. Therefore, we gave it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
University of Oklahoma Health Sciences Center, Oklahoma Shared Clinical and Translational Resources
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I saw this trial on your website and thought it would be a great way to show my support. The thought of being a part of a medical breakthrough would be pretty amazing.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. University of Oklahoma Health Sciences Center, Oklahoma Shared Clinical and Translational Resources: < 24 hours
~3 spots leftby Apr 2024