This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, diabetic peripheral neuropathy
Treatments exenatide, glargine
Sponsor University of Michigan
Collaborator Amylin Pharmaceuticals, LLC.
Start date June 2008
End date May 2014
Trial size 60 participants
Trial identifier NCT00855439, H80-US-X012


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
exenatide Byetta
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
(Active Comparator)
Subjects will take 1 daily injection of insulin glargine for 18 months.
glargine Lantus
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

Primary Outcomes

Nerve Conduction Studies
time frame: 18 Months

Secondary Outcomes

Cardiac Autonomic Neuropathy
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Single-center, Proof of Concept, Randomized, Controlled Parallel Group Clinical Trial of the Effects of Exenatide Versus a Long Acting Insulin Analog for 18 Months to Evaluate the Efficacy of Exenatide Therapy in Patients With Diabetic Peripheral Neuropathy and Type 2 Diabetes
Principal investigator Rodica Pop-Busui, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Michigan.