Trial · Interventional

CompletedNot applicableResults postedRegistry data

Evaluation of Exenatide in Patients With Diabetic Neuropathy

NCTNCT00855439Other idH80-US-X012

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 46 participants (actual)
Sponsor: University of Michigan · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jun 2008
Primary completion: May 2014
Completion: May 2014
First posted: 4 Mar 2009 (estimated)
Last update posted: 1 Mar 2017
Conditions: Type 2 Diabetes Mellitus · Diabetic Peripheral Neuropathy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008201020122014

N/A
Evaluation of Exenatide in Patients With Diabetic Neuropathy
NCT00855439
Jun 2008 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ExenatideDrug
GlargineDrug

Arms2

Experimental
Exenatide
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
Active comparator
glargine
Subjects will take 1 daily injection of insulin glargine for 18 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

Confirmed Clinical Neuropathy (CCN)
Time frame · 18 Months
Registry 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).

Secondary outcomes(2)

Cardiac Autonomic Neuropathy (CAN)
Time frame · 18 months
Registry description
Group differences in E/I ratio, a measure of cardiac autonomic function.
Cardiac Autonomic Neuropathy
Time frame · 18 month
Registry description
resting heart rate as marker of autonomic function at rest

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 18 Months

Confirmed Clinical Neuropathy (CCN)

Group	Value (participants)
Exenatide	14
Glargine	18

Secondary and other outcome results(3)

Secondary outcomeMean· 18 months

Cardiac Autonomic Neuropathy (CAN)

Group	Value (unit-less measure)	Spread
Exenatide	1.1	0.1
Glargine	1.1	0.4

Secondary outcomeMean· 18 month

Cardiac Autonomic Neuropathy

Group	Value (beats per minute)	Spread
Exenatide	70	9
Glargine	77	10

Other pre specified outcomeMean· 12 months

Intra-epidermal Nerve Fiber Density

Group	Value (nerve fibers per mm of skin)	Spread
Exenatide	2.1	3.5
Glargine	4.6	2.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ExenatideSubjects will take exenatide by subcutaneous injection twice daily for 18 months 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	–	6 / 22	9 / 22
GlargineSubjects will take 1 daily injection of insulin glargine for 18 months. 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	–	8 / 24	19 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

6 results

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.

Jaiswal et al. 2015Journal of diabetes and its complicationscited by 72

PMID 26264399PMC4656068DOI 10.1016/j.jdiacomp.2015.07.013PUB-26264399

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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