What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy include LX9211, benfotiamine, and pregabalin. LX9211 is still under investigation, so specific side effects are not well-documented. Benfotiamine is generally well-tolerated, but further studies are needed to confirm its safety profile. Pregabalin, used for various neuropathic pain conditions, can cause dizziness, somnolence, peripheral edema, and weight gain. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic neuropathy, focusing primarily on pain management. These include anticonvulsants like pregabalin and gabapentin, antidepressants such as duloxetine and amitriptyline, and topical treatments like capsaicin. While LX9211, an AAK1 inhibitor, is being studied for its potential in treating diabetic neuropathic pain, there are no current FDA-approved treatments specifically targeting AAK1 inhibition for this condition.

What other types of research exist?

Promising novel alternatives to LX9211 for diabetic neuropathy patients include GLP-1 receptor agonists like liraglutide and lixisenatide, which have shown benefits in reducing diabetic complications. Additionally, SGLT2 inhibitors such as empagliflozin and dapagliflozin have demonstrated cardiovascular and renal benefits, which may indirectly improve neuropathic outcomes. MLR-1023, a novel insulin sensitizer, also shows potential due to its mechanism of action in improving glycemic control.

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LX9211 for Diabetic Neuropathy (PROGRESS Trial)

Phase 2

Waitlist Available

Research Sponsored by Lexicon Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening

Adult male and female participants ≥18 years of age at the Screening Visit

Must not have

History of neurolytic or neurosurgical therapy for DPNP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Summary

This trial is testing a new drug called LX9211 to see if it can reduce nerve pain in people with diabetes. The drug works by blocking pain signals in the nerves. Researchers want to find out if it is more effective than other treatments. A similar drug was previously tested for similar conditions but its development was halted due to safety concerns.

Who is the study for?

Adults over 18 with a BMI between 18.0 and 40.0 kg/m^2, diagnosed with type 1 or type 2 diabetes and suffering from chronic diabetic peripheral neuropathic pain for at least six months can join this study. They must have stable diabetes management for three months and an A1C level of ≤11%. People using opioids, neurolytic therapies, topical analgesics for neuropathy recently, or NSAIDs within two weeks cannot participate.

What is being tested?

The trial is testing the effectiveness of a new medication called LX9211 against a placebo in reducing pain caused by diabetic peripheral neuropathy. Participants won't know if they're receiving the actual drug or the placebo as both are blinded.

What are the potential side effects?

While specific side effects of LX9211 aren't listed here, common side effects in trials like this may include headache, dizziness, nausea, fatigue, and potential allergic reactions to the medication components.

Eligibility Criteria

Inclusion Criteria

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

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I have diabetes (type 1 or 2) with chronic nerve pain.

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I am 18 years old or older.

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I have had pain from diabetic nerve damage for at least 6 months.

Exclusion Criteria

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

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I have had nerve treatment or surgery for diabetic nerve pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)

Secondary study objectives

Change from Baseline to Week 8 in Burning Pain

Change from Baseline to Week 8 in Pain Interference on Sleep

Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LX9211 Low DoseExperimental Treatment1 Intervention

LX9211 low dose, orally, once daily during a blinded treatment period.

Group II: LX9211 High Dose Followed by Low DoseExperimental Treatment1 Intervention

LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Group III: LX9211 High DoseExperimental Treatment1 Intervention

LX9211 high dose, orally, once daily during a blinded treatment period.

Group IV: LX9211 PlaceboPlacebo Group1 Intervention

LX9211 matching placebo, orally, once daily during a blinded treatment period.

0 / 4Eligibility 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 medications like anticonvulsants (e.g., pregabalin, gabapentin), antidepressants (e.g., duloxetine, amitriptyline), and topical agents (e.g., capsaicin). These treatments primarily work by modulating pain pathways and neurotransmitter levels to reduce pain perception. For instance, anticonvulsants stabilize nerve cell membranes, while antidepressants increase serotonin and norepinephrine levels, which can help alleviate pain. The relevance of these treatments lies in their ability to manage chronic pain, improve quality of life, and enhance daily functioning for patients. AAK1 inhibition, as studied in the LX9211 trial, represents a novel approach by targeting specific molecular pathways involved in pain signaling, potentially offering more targeted and effective pain relief for Diabetic Neuropathy patients.

Neuropathic Pain: Mechanism-Based Therapeutics.