Evaluation of Exenatide in Patients With Diabetic Neuropathy
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Diabetic Peripheral Neuropathy
Intervention: Exenatide (Drug); Glargine (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Rodica Pop-Busui, MD, PhD, Principal Investigator, Affiliation: University of Michigan
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Confirmed Clinical Neuropathy (CCN)
Secondary outcome: Cardiac Autonomic Neuropathy (CAN)Cardiac Autonomic 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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
The University of Michigan Health System, Ann Arbor, Michigan 48109, United States
Additional Information
Starting date: June 2008
Last updated: April 23, 2015
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