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Evaluation of Exenatide in Patients With Diabetic Neuropathy

This study is currently recruiting participants.
Verified June 2012 by University of Michigan
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier:
NCT00855439
First received: March 3, 2009
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Diabetic Peripheral Neuropathy
 Drug: Exenatide
Drug: Glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-center, Proof of Concept, Randomized, Controlled Parallel Group Clinical Trial of the Effects of Exenatide Versus a Long Acting Insulin Analog for 18 Months to Evaluate the Efficacy of Exenatide Therapy in Patients With Diabetic Peripheral Neuropathy and Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Nerve Conduction Studies [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac Autonomic Neuropathy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855439

Contacts
Contact: Catherine L. Martin, MS 734-936-6465 martinc@umich.edu
Contact: Rodica Pop-Busui, MD, PhD 734-763-3056 rpbusui@umich.edu

Locations
United States, Michigan
The University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Catherine L Martin, MS     734-936-6465     martinc@umich.edu    
Contact: Rodica Pop-Busui, MD, PhD     734-763-3056     rpbusui@umich.edu    
Principal Investigator: Rodica Pop-Busui, MD, PhD            
Sub-Investigator: James Albers, MD, PhD            
Sub-Investigator: Eva Feldman, MD, PhD            
Sponsors and Collaborators
University of Michigan
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Principal Investigator: Rodica Pop-Busui, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Rodica Pop-Busui, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00855439     History of Changes
Other Study ID Numbers: H80-US-X012
Study First Received: March 3, 2009
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Diabetes
Neuropathy
Glucose
 Control
Peripheral
Autonomic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Signs and Symptoms
Poisoning
Substance-Related Disorders
Exenatide
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013