| Trial ID: | L3270 |
| Source ID: | NCT00855439
|
| Associated Drug: |
Exenatide
|
| Title: |
Evaluation of Exenatide in Patients With Diabetic Neuropathy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00855439/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Diabetic Peripheral Neuropathy
|
| Interventions: |
DRUG: Exenatide|DRUG: Glargine
|
| Outcome Measures: |
Primary: Confirmed Clinical Neuropathy (CCN), 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)., 18 Months | Secondary: Cardiac Autonomic Neuropathy (CAN), Group differences in E/I ratio, a measure of cardiac autonomic function., 18 months|Cardiac Autonomic Neuropathy, resting heart rate as marker of autonomic function at rest, 18 month | Other: Intra-epidermal Nerve Fiber Density, Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin., 12 months
|
| Sponsor/Collaborators: |
Sponsor: University of Michigan | Collaborators: Amylin Pharmaceuticals, LLC.|Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
46
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2014-05
|
| Results First Posted: |
2015-05-12
|
| Last Update Posted: |
2017-03-01
|
| Locations: |
The University of Michigan Health System, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00855439
|
