Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00101426

Enrollment

500

Registered

2005-01-11

Start date

2004-10-31

Completion date

2006-09-30

Last updated

2008-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Keywords

Diabetic sensorimotor polyneuropathy, Diabetic Neuropathy

Brief summary

This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.

Interventions

DRUGranirestat, (AS-3201)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients with the following may enter: Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test. * 18 to 70 years old of either sex and any race * Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry * Healthy in general * No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening * Female patients of childbearing potential must have a negative serum pregnancy test

Exclusion criteria

* Known non-diabetic causes of neuropathic symptoms * Diabetic patients with no neuropathy or severe neuropathy * Used any Aldose Reductase Inhibitors within one year of screening * Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease * A history of systemic carcinoma within five years of screening * A history of epilepsy or serious head injury * A history or evidence of drug or alcohol abuse * Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency * A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously

Design outcomes

Primary

Measure	Time frame
Efficacy	—

Secondary

Measure	Time frame
Safety	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026