Status:
COMPLETED
Evaluation of Exenatide in Patients With Diabetic Neuropathy
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ne...
Detailed Description
This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used by people with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00855439
Start Date
June 1 2008
End Date
May 1 2014
Last Update
March 1 2017
Active Locations (1)
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1
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109