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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
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.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Novolin Toronto insulin:Active Comparator|
|Normal saline:Placebo Comparator|
|Drug:Novolin Toronto insulin|
Subjects randomized to active drug are provided with 20 IU BID of Novolin Toronto at randomization (week 5). The dosing is prescribed to be taken 30 minutes after the morning meal (breakfast) and 30 minutes after the evening meal (supper). Subjects are asked to consume their meals and take their doses of study treatment within the same time frame each day. Dose escalations occur every 2 weeks with the insulin increasing to 40 IU BID at week 7, then 80 IU BID at week 9. The study completes at week 11. The total treatment period is 6 weeks. The insulin is diluted with an amount of normal saline to provide a total volume in the study treatment vial to equal 1.1 milliliters.
Subjects randomized to placebo are provided with 1.1 milliliters of normal saline at randomization (week 5). The study completes at week 11. The total treatment period is 6 weeks. The dosing is prescribed to be taken 30 minutes after the morning meal (breakfast)and 30 minutes after the evening meal (supper). Subjects are asked to consume their meals and take their doses of study treatment within the same time frame each day. The amount of normal saline in the study treatment vial (1.1 milliliters) is identical in volume to the active insulin being used in the study .
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
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.
- 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
- 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.
- Investigator: Lawrence M Korngut, MD, FRCPC - Principal Investigator - University of Calgary