Evaluation of Exenatide in Patients With Diabetic Neuropathy

NCT ID: NCT00855439

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2014-05-31

Brief 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.

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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide

Subjects will take exenatide by subcutaneous injection twice daily for 18 months

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

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

glargine

Subjects will take 1 daily injection of insulin glargine for 18 months.

Group Type: ACTIVE_COMPARATOR

Glargine

Intervention Type: DRUG

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

Interventions

Exenatide

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

Intervention Type: DRUG

Glargine

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

Intervention Type: DRUG

Other Intervention Names

Byetta; Lantus

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Rodica Pop-Busui

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodica Pop-Busui, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

References

Jaiswal M, Martin CL, Brown MB, Callaghan B, Albers JW, Feldman EL, Pop-Busui R. Effects of exenatide on measures of diabetic neuropathy in subjects with type 2 diabetes: results from an 18-month proof-of-concept open-label randomized study. J Diabetes Complications. 2015 Nov-Dec;29(8):1287-94. doi: 10.1016/j.jdiacomp.2015.07.013. Epub 2015 Jul 17.

Reference Type: DERIVED

PMID: 26264399 (View on PubMed)

Other Identifiers

H80-US-X012

Identifier Type: -

Identifier Source: org_study_id