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A Single-center, Proof of Concept, Randomized, Controlled Parallel Group Clinical Trial of the Effects of Exenatide Versus a Long Acting Insulin Analog for 18 Months to Evaluate the Efficacy of Exenatide Therapy in Patients With Diabetic Peripheral Neuropathy and Type 2 Diabetes

This study is currently Recruiting

August 2011 By University of Michigan

First Recieved on March 3, 2009

Last Updated on August 4, 2011

Sponsor: University of Michigan
Collaborators: Amylin Pharmaceuticals, Inc.
Information provided by: University of Michigan
Identifier: NCT00855439

Purpose

This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Type 2 diabetes treated with one or more oral agents - Persistent fasting glucose > 140 mg/dl or HbA1c > 7% - Stable and maximally effective doses of one or more oral agents for 3 months - Presence of diabetic peripheral neuropathy - Age between 18 and 70 years - No risk factors or other causes of neuropathy - Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration Exclusion Criteria: - Nursing mothers or pregnant women - A history of previous kidney, pancreas or cardiac transplantation - A past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis C, end stage renal disease, lupus) - Amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity - HbA1c > 10% - Participation in an experimental medication trial within 3 months of starting the study. - Undergoing therapy for malignant disease other than basal- or squamous cell carcinoma - Requiring long-term glucocorticoid therapy - Inability or unwillingness to comply with the protocol

Investigators

  • Investigator: Rodica Pop-Busui, MD, PhD - Principal Investigator - University of Michigan

Locations

  • The University of Michigan Health System

    Ann Arbor, Michigan 48109 United States

Conditions related to this trial:

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