The Effect of Ruboxistaurin on Small Fiber Function

Chromaderm

Status and phase

Completed

Phase 2

Conditions

Diabetic Neuropathy

Treatments

Drug: Ruboxistaurin

Study type

Interventional

Funder types

Industry

Identifiers

7550

B7A-MC-MBDO

Details and patient eligibility

About

To determine the effect of Ruboxistaurin on small fiber function.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have Type 1 or Type 2 diabetes mellitus
Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus
Patients must have blood glucose control measured as HbA1c=<11%
Patients must be 18 years of age or older.
Patients must be able to return to all follow-up visits

Exclusion criteria

Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies
Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy.
Patient currently has uncontrolled high blood pressure
You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems
You are a woman of childbearing age and unwilling or unable to use effective contraceptive.