Evaluation of Exenatide in Patients With Diabetic Neuropathy
This trial is active, not recruiting.
|Conditions||type 2 diabetes mellitus, diabetic peripheral neuropathy|
|Sponsor||University of Michigan|
|Collaborator||Amylin Pharmaceuticals, LLC.|
|Start date||June 2008|
|End date||May 2014|
|Trial size||60 participants|
|Trial identifier||NCT00855439, H80-US-X012|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Nerve Conduction Studies
time frame: 18 Months
Cardiac Autonomic Neuropathy
time frame: 18 months
Male or female participants from 18 years up to 70 years old.
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
|Official title||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|
|Principal investigator||Rodica Pop-Busui, MD, PhD|
|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 type 2 diabetes to control blood sugar. Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral neuropathy. There is also some evidence that exenatide may have additional beneficial effects on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected to have similar improvement in blood sugar control. This study will show whether exenatide has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.|
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