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Evaluation of Exenatide in Patients With Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855439
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : May 12, 2015
Last Update Posted : March 1, 2017
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetic Peripheral Neuropathy Drug: Exenatide Drug: Glargine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exenatide
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Drug: 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
Other Name: Byetta

Active Comparator: glargine
Subjects will take 1 daily injection of insulin glargine for 18 months.
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
Other Name: Lantus

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Intra-epidermal Nerve Fiber Density [ Time Frame: 12 months ]
    Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855439

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United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
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Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rodica Pop-Busui, Assistant Professor of Internal Medicine, University of Michigan Identifier: NCT00855439     History of Changes
Other Study ID Numbers: H80-US-X012
First Posted: March 4, 2009    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: March 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rodica Pop-Busui, University of Michigan:
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists