Evaluation of Exenatide in Patients With Diabetic Neuropathy

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855439
• Other study ID #: H80-US-X012
• 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

• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Type 2 Diabetes Mellitus

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