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Anti-diabetic drug

Metformin for Achilles Tendinopathy

Phase 1

Recruiting

Led By James H Wang, PhD

Research Sponsored by James Wang

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of Achilles tendinopathy

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 16 weeks

Awards & highlights

Study Summary

This trial will test if metformin can reduce chronic Achilles tendon pain and help heal the tendon in non-diabetics. 20 people will take metformin, 20 will take placebo + exercise.

Who is the study for?

This trial is for non-diabetic individuals with chronic Achilles tendon pain who can consent to participate, have a specific level of disability due to the pain, and show signs of tendon damage on an ultrasound. They must not have had recent treatments or surgery on the tendon, be pregnant or breastfeeding, suffer from systemic inflammatory diseases or severe liver problems, take certain medications like metformin recently, or have a BMI over 30.Check my eligibility

What is being tested?

The study is testing if taking metformin pills helps reduce tendon pain and aids in healing compared to placebo (dummy pills). Both groups will also follow a home exercise program. There are two groups: one receiving metformin capsules for 16 weeks and another receiving placebo tablets for the same duration.See study design

What are the potential side effects?

Metformin may cause side effects such as stomach upset, diarrhea, nausea and vomiting. It might also lead to more serious conditions like lactic acidosis but this is rare. The exact side effects in the context of treating tendinopathy are being studied.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Achilles tendinopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 16 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

Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score

Secondary outcome measures

Change in VAS score

Change in VAS score during hopping

Change in counter movement jump height

+8 more

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group, Metformin CapsulesExperimental Treatment1 Intervention

Treatment Group (n=20) Week 1: One metformin ER capsule (500 mg) daily Week 2: Two metformin (ER) capsules (1,000 mg) daily Week 3: Three metformin (ER) capsules (1,500 mg) daily Week 4-16: Four metformin (ER) capsules (2,000 mg) daily

Group II: Placebo Group, Placebo CapsulesPlacebo Group1 Intervention

Placebo Group (n=20) Week 1: One placebo capsule (500 mg) daily Week 2: Two placebo capsules (1,000 mg) daily Week 3: Three placebo capsules (1,500 mg) daily Week 4-16: Four placebo capsules (2,000 mg) daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

James WangLead Sponsor

United States Department of DefenseFED

865 Previous Clinical Trials

327,659 Total Patients Enrolled

11 Trials studying Chronic Pain

2,655 Patients Enrolled for Chronic Pain

James H Wang, PhDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

What qualifications are necessary to be accepted into this medical experiment?

"To meet the criteria for this trial, applicants should possess a diagnosis of tendinopathy and be between the ages of 18 to 50. The upper limit is 40 participants in total."

Answered by AI

Has the FDA sanctioned Metformin Capsules for Treatment Group?

"As this is a Phase 1 trial, with comparatively limited evidence of efficacy and safety, Treatment Group's Metformin Capsules received an overall score of 1."

Answered by AI

Does this experiment accept participants aged 35 and over?

"According to the study requirements, only those aged 18-50 can qualify as participants. There are 43 clinical trials that accept younger patients and 441 experiments for older individuals beyond 65 years old."

Answered by AI

Are recruitment efforts actively underway for this investigation?

"Evidenced on clinicaltrials.gov, this study has ceased recruiting participants at the present moment in time. The trial was first posted on October 1st 2023 and saw its last update 19 days later on October 19th 23. 503 other trials are still actively enrolling people despite this being temporarily put to a halt."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Managing Chronic Tendon Pain by Metformin

James Wang 2024. "Managing Chronic Tendon Pain by Metformin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06100822.

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