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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00855439
Other study ID # H80-US-X012
Secondary ID
Status Completed
Phase N/A
First received March 3, 2009
Last updated April 23, 2015
Start date June 2008
Est. completion date May 2014

Study information

Verified date April 2015
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
United States The University of Michigan Health System Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan Amylin Pharmaceuticals, LLC., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Intra-epidermal Nerve Fiber Density Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin. 12 months No
Primary 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 No
Secondary Cardiac Autonomic Neuropathy (CAN) Group differences in E/I ratio, a measure of cardiac autonomic function. 18 months No
Secondary Cardiac Autonomic Neuropathy resting heart rate as marker of autonomic function at rest 18 month No
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