Evaluation of Exenatide in Patients With Diabetic Neuropathy

University of Michigan46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Diabetic Peripheral Neuropathy

Interventions

ExenatideDRUG

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

GlargineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

The University of Michigan Health System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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).

Time frame: 18 Months

Secondary Outcomes

Cardiac Autonomic Neuropathy (CAN)

Group differences in E/I ratio, a measure of cardiac autonomic function.

Time frame: 18 months

Cardiac Autonomic Neuropathy

resting heart rate as marker of autonomic function at rest

Time frame: 18 month

Data from ClinicalTrials.gov

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