Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Eisai

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Treatments: Drug: Ranirestat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927914

AS3201-G000-291

2008-002843-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.

Enrollment: 800 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
• Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
• Female subjects, who are of non-reproductive potential (>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
• Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.

Exclusion criteria

• History of diabetic foot ulcers or lower extremity amputation.
• Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
• Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 3 patient groups, including a placebo group

Ranirestat 80 mg

Experimental group

Description:

Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Treatment:

Drug: Ranirestat

Ranirestat 40 mg

Experimental group

Description:

One 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Treatment:

Drug: Ranirestat

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Treatment:

Drug: Placebo