Status:
COMPLETED
Safety Study of Intranasal Insulin in Type 1 Diabetes and Diabetic Peripheral Neuropathy
Lead Sponsor:
University of Calgary
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the safety and tolerability of intranasal insulin in people with type 1 diabetes and diabetic peripheral neuropathy and to determine whether intranasal insulin is ...
Detailed Description
Diabetic polyneuropathy (DPN) is a common complication of human type I and II diabetes mellitus, identified in up to 50% of diabetic subjects regardless of age or type of diabetes. As the global burde...
Eligibility Criteria
Inclusion
- Patients classified as having type 1 diabetes mellitus according to the Canadian Diabetes Association Criteria.
- Patients clinically defined as having DPN, meeting at least two of the following conditions:
- clinical signs of polyneuropathy;
- Symptoms of nerve dysfunction;
- Nerve conduction deficits in at least 2 nerves.
- Aged 18 through 70 years (inclusive).
- Body Mass Index (BMI) \<30 kilograms/meter2.
Exclusion
- Any other possible etiology contributing to the neuropathy:
- History of prolonged untreated hypothyroidism.
- Presence of untreated B12 deficiency.
- Presence of a paraproteinemia, detected using serum protein electrophoresis with a minimal threshold detection of 2 g/L.
- Use of a neurotoxic medication with a clear association with peripheral neuropathy within the past 1 year based upon clinical impression of association.
- Previous exposure chemotherapeutic agents with a clear association with peripheral neuropathy at any time.
- History of 2 or more severe hypoglycemic episodes within the previous 6 months.
- History of clustering of hypoglycemia episodes within the previous 12 months.
- History of active or recent (\<5 years) malignancy.
- History of systemic or local nasal disease that would complicate the use of intranasal insulin.
- Presence of diabetic nephropathy requiring dialysis.
- Presence of active proliferative retinopathy requiring surgery within 6 months.
- Pregnancy or lactation (female subject of reproductive age must be on contraception).
- Active cardiovascular disease:
- Recent angina (\<5 years)
- Recent myocardial infarction (\<5 years)
- Congestive heart failure
- Active psychiatric disorder or previous history of psychosis.
- Unable to understand or provide consent.
- Previously documented hypersensitivity to insulin.
- History of hypoglycemia unawareness.
- Glycated hemoglobin \< 7.0%.
- Ongoing involvement in another investigational drug trial.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01469559
Start Date
August 1 2011
End Date
July 1 2012
Last Update
August 10 2012
Active Locations (1)
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1
Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6