What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy include tricyclic antidepressants (e.g., amitriptyline), gabapentin, pregabalin, duloxetine, and venlafaxine. Known side effects of tricyclic antidepressants include dry mouth, constipation, urinary retention, and drowsiness. Gabapentin and pregabalin can cause dizziness, fatigue, and peripheral edema. Duloxetine and venlafaxine, both serotonin-norepinephrine reuptake inhibitors (SNRIs), may lead to nausea, dry mouth, dizziness, and increased blood pressure. These side effects should be discussed with a healthcare provider to tailor the treatment to the patient's needs.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic neuropathy, focusing on different mechanisms of action. Notably, GLP-1 receptor agonists like liraglutide and dulaglutide have been studied for their potential benefits in diabetic neuropathy, although their primary indication is for glycemic control in type 2 diabetes. Additionally, pregabalin and duloxetine are FDA-approved specifically for managing neuropathic pain associated with diabetic peripheral neuropathy. These treatments reflect a range of mechanisms, from modulating neurotransmitter release to improving glycemic control, aligning with the diverse approaches being explored in the EPPIC-Net trial.

What other types of research exist?

Promising novel alternatives for treating diabetic neuropathy in 2024 include: 1) Combination therapies such as amitriptyline with pregabalin or duloxetine with pregabalin, which have shown efficacy in recent trials. 2) New pharmacological agents being tested under the EPPIC-Net platform, which aims to assess multiple treatments for painful diabetic peripheral neuropathy. 3) Multidisciplinary care approaches that integrate medical management, rehabilitation, and mental health treatment, which have been shown to improve outcomes in patients with complex pain conditions.

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NEW Diabetes and Pain Medication Study

Phase 2

Recruiting

Led By Jessica Robinson-Papp, MD

Research Sponsored by James P. Rathmell, MD

Eligibility Criteria Checklist

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

Must have

Do you have pain in your lower extremities (legs, feet, toes, ankles, etc.)?

Do you have Type 2 Diabetes?

Must not have

Have you had a heart attack or stroke?

Timeline

Screening 45 weeks

Treatment 12 weeks

Follow Up 107 days

Summary

This trial tests several treatments for nerve pain in diabetic patients to identify effective therapies for reducing this type of pain.

Who is the study for?

This trial is for people with Type 2 Diabetes who suffer from painful diabetic neuropathy, specifically pain in the lower extremities. Participants should have stable diabetes treatment for at least three months without expected changes in their medication regimen. Those who've had a recent heart attack or stroke cannot join.

What is being tested?

The study is part of EPPIC-Net and aims to test various treatments for Painful Diabetic Peripheral Neuropathy (PDPN) using a platform protocol that allows multiple drugs to be tested under one overarching study design.

What are the potential side effects?

Since specific interventions are not listed, side effects will vary depending on the particular treatment being tested but may include typical drug-related reactions such as nausea, dizziness, skin irritation, or other symptoms related to nerve pain medications.

Eligibility Criteria

Inclusion Criteria

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

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I experience pain in my legs, feet, toes, or ankles.

Select...

I have Type 2 Diabetes.

Select...

I have diabetic neuropathy.

Select...

My diabetes treatment has been stable for at least 3 months with no expected changes.

Exclusion Criteria

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

Select...

I have had a heart attack or stroke.

Timeline

Screening ~ 45 weeks1 visit

Treatment ~ 12 weeks6 visits

Follow Up ~ 107 days4 visits

Screening ~ 45 weeks

Treatment ~ 12 weeks

Follow Up ~107 days

This trial's timeline: 45 weeks for screening, 12 weeks for treatment, and 107 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Daily 0-10 pain NRS

Secondary study objectives

Generalized Anxiety Disorder - 2 item scale (GAD-2)

Opioid Use Questionnaire (OUQ)

PROMIS Physical Functioning Short-Form 6b

+7 more

Other study objectives

Neuropathy Examination

Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EN21-01 ISAExperimental Treatment1 Intervention

The EN21-01 Intervention Specific Analysis is detailed in the protocol (NCT#)

Group II: Placebo ComparatorPlacebo Group1 Intervention

Each ISA will detail the use of the Placebo Comparator.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Neuropathy include alpha-lipoic acid, which acts as an antioxidant reducing oxidative stress and improving nerve function; sodium valproate, which modulates neurotransmitter release and stabilizes neuronal activity; carbamazepine, which blocks sodium channels to reduce nerve excitability and pain; and opioids, which bind to opioid receptors to inhibit pain signaling. These mechanisms are crucial for Diabetic Neuropathy patients as they target different aspects of nerve damage and pain, offering a multifaceted approach to managing symptoms and improving quality of life.

National Institute of Neurological Disorders and Stroke (NINDS): advances in understanding and treating neuropathy, 24-25 October 2006; Bethesda, Maryland.