N/A
N=46
Evaluation of Exenatide in Patients With Diabetic Neuropathy
Type 2 Diabetes Mellitus · Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00855439 ↗Enrolled (actual)
46
Serious AEs
30.4%
Results posted
May 2015
Primary outcome: Primary: Confirmed Clinical Neuropathy (CCN) — 14; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exenatide (Drug); Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Clinical Neuropathy (CCN) |
14; 18 | — |
| SECONDARY Cardiac Autonomic Neuropathy (CAN) |
1.1; 1.1 | — |
| SECONDARY Cardiac Autonomic Neuropathy |
70; 77 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00855439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.