Evaluation of Exenatide in Patients With Diabetic Neuropathy
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.
Type 2 Diabetes Mellitus
Diabetic Peripheral Neuropathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Confirmed Clinical Neuropathy (CCN) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve).
- Cardiac Autonomic Neuropathy (CAN) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Group differences in E/I ratio, a measure of cardiac autonomic function.
- Cardiac Autonomic Neuropathy [ Time Frame: 18 month ] [ Designated as safety issue: No ]resting heart rate as marker of autonomic function at rest
- Intra-epidermal Nerve Fiber Density [ Time Frame: 12 months ] [ Designated as safety issue: No ]Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.
|Study Start Date:||June 2008|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels
Other Name: Byetta
Active Comparator: glargine
Subjects will take 1 daily injection of insulin glargine for 18 months.
Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control
Other Name: Lantus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855439
|United States, Michigan|
|The University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Rodica Pop-Busui, MD, PhD||University of Michigan|