Eisai Inclusion/Exclusion Print E-mail

Eisai

A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

 

Subjects will be included in the study if they meet the following criteria:

  1. Male or female subjects aged between 18 and 75 years old at screening

 

  1. Subjects with type 1 or type 2, insulin-dependent or non insulin-dependent diabetes mellitus, with a diagnosis at least 12 months prior to screening

 

  1. Subjects whose glycemic control has been optimized and stable for at least 3 months prior to screening. Stable control includes no dose changes to existing medications for glycemic control (other than insulin) and no medications being initiated for glycemic control in the past 3 months prior to screening

 

  1. Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes

 

  1. 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 who meet any of the exclusion criteria will not be eligible for the study:

  1. History of diabetic foot ulcers or lower extremity amputation
  2. Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms (e.g. sequelae of cerebrovascular disease, lumbar radiculopathy, entrapment neuropathy, etc.)
  3. History of evidence of drug or alcohol abuse
  4. History of known or suspected diagnosis of acquired immune deficiency syndrome, or who have tested seropositive for HIV antibody or antigen previously
  5. Significant cardiovascular disease
  6. Significant hepatic disease (e.g. Hepatitis B or C)
  7. Morbid obesity (BMI (body mass index) > 40 kg/m2) at screening
  8. History of cancer within 5 years prior to screening, with the exception of basal cell carcinoma
  9. Current major depressive disorder
  10. Subjects who have received an investigational medicinal product within 3 months prior to the screening visit or subjects who have participated in a previous study with ranirstat
 
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