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A Phase IIa Dose Escalation Pilot Study to Investigate the Safety and Tolerability of Intranasal Insulin in Subjects With Diabetic Polyneuropathy.

This study is currently Recruiting

November 2011 By University of Calgary

First Recieved on November 8, 2011

Last Updated on November 9, 2011

Sponsor: University of Calgary
Collaborators:
Information provided by: University of Calgary
Identifier: NCT01469559

Purpose

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 effective in slowing the progression of diabetic neuropathy.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - 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: 1. clinical signs of polyneuropathy; 2. Symptoms of nerve dysfunction; 3. Nerve conduction deficits in at least 2 nerves. - Aged 18 through 70 years (inclusive). - Body Mass Index (BMI) <30 kilograms/meter2. Exclusion Criteria: - Any other possible etiology contributing to the neuropathy: 1. History of prolonged untreated hypothyroidism. 2. Presence of untreated B12 deficiency. 3. Presence of a paraproteinemia, detected using serum protein electrophoresis with a minimal threshold detection of 2 g/L. 4. Use of a neurotoxic medication with a clear association with peripheral neuropathy within the past 1 year based upon clinical impression of association. 5. 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: 1. Recent angina (<5 years) 2. Recent myocardial infarction (<5 years) 3. 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.

Investigators

  • Investigator: Lawrence M Korngut, MD, FRCPC - Principal Investigator - University of Calgary

Locations

  • Heritage Medical Research Clinic

    Calgary, Alberta T2N 4Z6 Canada

Conditions related to this trial:

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