Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

Study Overview
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Brief Summary
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The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

Detailed Description
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The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy

Conditions
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Diabetic Polyneuropathy

Intervention / Treatment
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* Drug: Placebo
* Drug: MCC-257
* Drug: MCC-257
* Drug: MCC-257


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is male or female, 18-70 years of age The patient has either type 1 or type 2 diabetes The patient has mild to moderate diabetic neuropathy The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests Exclusion Criteria: Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix BMI>40 A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function Women of childbearing potential who do not refrain from sexual activity or use adequate contraception Pregnant or lactating women An ALT or AST value >2X upper limit of normal (ULN) Clinically significant cardiovascular disease within the last six (6) months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* once daily for 24 weeks<br>|
| Experimental: 2<br> | Drug: MCC-257<br>* 20mg, once daily for 24 weeks<br>|
| Experimental: 3<br> | Drug: MCC-257<br>* 40mg, once daily for 24 weeks<br>|
| Experimental: 4<br> | Drug: MCC-257<br>* 80mg, once daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Conduction Studies |  | Day 1, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve fiber density |  | Day 1, Week 24 | 
| QST |  | Day 1, Week 12, Week 24 | 
| Symptom |  | Day 1, Week 12, Week 24 | 
| Clinical Global Impression |  | Week 12, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathy, Nerve Conduction