Evaluation of Exenatide in Patients With Diabetic Neuropathy

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company
• Treatments: Exenatide; Insulin; Insulin Glargine

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