Evaluation of Exenatide in Patients With Diabetic Neuropathy

NCT00855439 | Completed Results

• 1 other identifier: H80-US-X012
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Peripheral Neuropathy

Keywords

Diabetes; Neuropathy; Glucose; Control; Peripheral; Autonomic

Outcome Measures

Primary Outcomes (1)

• 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).

  18 Months

Secondary Outcomes (2)

• Cardiac Autonomic Neuropathy (CAN)

  18 months

• Cardiac Autonomic Neuropathy

  18 month

Other Outcomes (1)

• Intra-epidermal Nerve Fiber Density

  12 months

Study Arms (2)

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

glargine

ACTIVE COMPARATOR

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

Drug: Glargine

Interventions

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

Also known as: Byetta

Exenatide

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

Also known as: Lantus

glargine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Amylin Pharmaceuticals, LLC.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

The University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 26264399 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Rodica Pop-Busui, MD, PhD
• Organization: University of Michigan

rpbusui@med.umich.edu

734 647-9809

Study Officials

• Rodica Pop-Busui, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: June 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 1, 2017
• Results First Posted: May 12, 2015

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)