Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: March 27, 2006
Last updated: December 26, 2007
Last verified: December 2007
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

Condition Intervention Phase
Diabetic Polyneuropathy
Drug: Placebo
Drug: MCC-257
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Nerve Conduction Studies [ Time Frame: Day 1, Week 24 ]

Secondary Outcome Measures:
  • Nerve fiber density [ Time Frame: Day 1, Week 24 ]
  • QST [ Time Frame: Day 1, Week 12, Week 24 ]
  • Symptom [ Time Frame: Day 1, Week 12, Week 24 ]
  • Clinical Global Impression [ Time Frame: Week 12, Week 24 ]

Enrollment: 420
Study Start Date: March 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
once daily for 24 weeks
Experimental: 2 Drug: MCC-257
20mg, once daily for 24 weeks
Experimental: 3 Drug: MCC-257
40mg, once daily for 24 weeks
Experimental: 4 Drug: MCC-257
80mg, once daily for 24 weeks

Detailed 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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00307749

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Principal Investigator: Professor Information at Mitsubishi Pharma America
  More Information Identifier: NCT00307749     History of Changes
Other Study ID Numbers: MCC-257-A03
Study First Received: March 27, 2006
Last Updated: December 26, 2007

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Nerve Conduction

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on April 21, 2017