Clinical trial NCT00855439: Evaluation of Exenatide in Patients With Diabetic Neuropathy
Official title: A Single-center,Proof of Concept,Randomized,Controlled Parallel Group Clinical Trial of the Effects of Exenatide vs. a Long Acting Insulin Analog to Evaluate the Efficacy of Exenatide in Patients With Diabetic Neuropathy and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Diabetic Peripheral Neuropathy
Keywords: Diabetes
Neuropathy
Glucose
Control
Peripheral
Autonomic
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
name: Eli Lilly and Company
First posted: 2009-03-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 neuropathy.

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 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.

Eligibility 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

Primary outcomes:
measure: Confirmed Clinical Neuropathy (CCN)
timeFrame: 18 Months
Secondary outcomes:
measure: Cardiac Autonomic Neuropathy (CAN)
timeFrame: 18 months
measure: Cardiac Autonomic Neuropathy
timeFrame: 18 month
Other outcomes:
measure: Intra-epidermal Nerve Fiber Density
timeFrame: 12 months
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rodica Pop-Busui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaiswal M, Martin CL, Brown MB, Callaghan B, Albers JW, Feldman EL, Pop-Busui R. Effects of exenatide on measures of diabetic neuropathy in subjects with type 2 diabetes: results from an 18-month proof-of-concept open-label randomized study. J Diabetes Complications. 2015 Nov-Dec;29(8):1287-94. doi: 10.1016/j.jdiacomp.2015.07.013. Epub 2015 Jul 17.