Evaluation of Exenatide in Patients With Diabetic Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00855439|
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : May 12, 2015
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Diabetic Peripheral Neuropathy||Drug: Exenatide Drug: Glargine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2008|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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
- Confirmed Clinical Neuropathy (CCN) [ Time Frame: 18 Months ]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 ]Group differences in E/I ratio, a measure of cardiac autonomic function.
- Cardiac Autonomic Neuropathy [ Time Frame: 18 month ]resting heart rate as marker of autonomic function at rest
- Intra-epidermal Nerve Fiber Density [ Time Frame: 12 months ]Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|