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Evaluation of Exenatide in Patients With Diabetic Neuropathy

Primary Purpose

Type 2 Diabetes Mellitus, Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Glargine
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Neuropathy, Glucose, Control, Peripheral, Autonomic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exenatide

glargine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cardiac Autonomic Neuropathy (CAN)
Group differences in E/I ratio, a measure of cardiac autonomic function.
Cardiac Autonomic Neuropathy
resting heart rate as marker of autonomic function at rest

Full Information

First Posted
March 3, 2009
Last Updated
January 12, 2017
Sponsor
University of Michigan
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00855439
Brief Title
Evaluation of Exenatide in Patients With Diabetic Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetic Peripheral Neuropathy
Keywords
Diabetes, Neuropathy, Glucose, Control, Peripheral, Autonomic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Arm Title
glargine
Arm Type
Active Comparator
Arm Description
Subjects will take 1 daily injection of insulin glargine for 18 months.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
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
Intervention Name(s)
Glargine
Other Intervention Name(s)
Lantus
Intervention Description
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 Outcome Measure Information:
Title
Confirmed Clinical Neuropathy (CCN)
Description
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 Outcome Measure Information:
Title
Cardiac Autonomic Neuropathy (CAN)
Description
Group differences in E/I ratio, a measure of cardiac autonomic function.
Time Frame
18 months
Title
Cardiac Autonomic Neuropathy
Description
resting heart rate as marker of autonomic function at rest
Time Frame
18 month
Other Pre-specified Outcome Measures:
Title
Intra-epidermal Nerve Fiber Density
Description
Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodica Pop-Busui, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26264399
Citation
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.
Results Reference
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Evaluation of Exenatide in Patients With Diabetic Neuropathy

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