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NCT Number: NCT00855439

Evaluation of Exenatide in Patients With Diabetic Neuropathy

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

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

Other names: Byetta

Glargine

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

Other names: Lantus

Primary outcomes

  1. Confirmed Clinical Neuropathy (CCN)

    Time frame: 18 Months

    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).

Secondary outcomes

  1. Cardiac Autonomic Neuropathy (CAN)

    Time frame: 18 months

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

  2. Cardiac Autonomic Neuropathy

    Time frame: 18 month

    resting heart rate as marker of autonomic function at rest

Other outcomes

  1. Intra-epidermal Nerve Fiber Density

    Time frame: 12 months

    Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.
  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2009
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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