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

Diabetic Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307749
• Other study ID #: MCC-257-A03
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2006
• Last updated: December 26, 2007
• Start date: March 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• Placebo
once daily for 24 weeks
• MCC-257
20mg, once daily for 24 weeks
• MCC-257
40mg, once daily for 24 weeks
• MCC-257
80mg, once daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Conduction Studies		Day 1, Week 24
Secondary	Nerve fiber density		Day 1, Week 24
Secondary	QST		Day 1, Week 12, Week 24
Secondary	Symptom		Day 1, Week 12, Week 24
Secondary	Clinical Global Impression		Week 12, Week 24