Safety Study of Intranasal Insulin in Type 1 Diabetes and Diabetic Peripheral Neuropathy (IIDPN)
|Diabetic Peripheral Neuropathy||Drug: Novolin Toronto insulin Drug: Normal saline||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase IIa Dose Escalation Pilot Study to Investigate the Safety and Tolerability of Intranasal Insulin in Subjects With Diabetic Polyneuropathy.|
- Hypoglycemia monitoring [ Time Frame: 8 weeks ]
Hypoglycemia is defined by the development of autonomic or neuroglycopenic symptoms, and with or without the presence of a blood glucose measurement.
All qualifying subjects are provided with blood glucose testing supplies to monitor blood glucoses six times daily from week 3 to week 11 of the study.
Any severe hypoglycemia or increase of hypoglycemia of greater than 30% from the baseline phase (week 3 to week 5) is deemed clinically significant and is reviewed by the investigator to determine subject continuation with study treatment.
- Treatment satisfaction questionnaire for medication (TSQM) [ Time Frame: 6 weeks ]The TQSM assesses the overall global impression of the treatment by the study subjects. During the study, the TSQM is administered at weeks 7, 9 and 11.
- Adverse effects [ Time Frame: 11 weeks ]The subject's overall health is assessed throughout the study to determine any changes with respect to existing history, in addition to capturing any new medical conditions that may arise.
- The UTAH early neuropathy scale [ Time Frame: 6 weeks ]The UTAH early neuropathy scale, a standarized physical examination scale, is used to measure changes in sensory neuropathy. During the study, the scale is administered at the time of randomization (week 5), then every 2 weeks until the end of study (week 11).
- Corneal confocal microscopy [ Time Frame: 6 weeks ]The corneal confocal microscopy measures corneal nerve fiber branch length and density. This procedure is done prior to week 5 (randomization) and immediately prior to week 11 (end of study).
- Electrophysiology [ Time Frame: 6 weeks ]
The following components will be measured to monitor changes in nerve conduction:
- Sural conduction velocity
- Radial SNAP amplitude
- Radial:Sural SNAP ratio
The nerve conduction tests are completed prior to week 5 (randomization) and immediately prior to week 11 (end of study).
- McGill pain questionnaire [ Time Frame: 6 weeks ]The McGill pain questionnaire, a standardized scale of rating pain on a scale of 0 (no pain) to 10 (worst pain), is used to monitor change in subject's pain symptoms. During the study, subjects complete this questionnaire at week 5 (randomization) and then every 2 weeks until the end of study (week 11).
- Short Form-36 (SF-36) Quality of life scale [ Time Frame: 6 weeks ]The SF-36 qualify of life scale, a standardized scale, is used to monitor change in subject reported functionality, well being, and overall health status. During the study, subjects complete this questionnaire at week 5 (randomization) and then every 2 weeks until the end of study (week 11).
|Study Start Date:||August 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Novolin Toronto insulin||
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.
|Placebo Comparator: Normal saline||
Drug: Normal saline
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 .
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01469559
|Heritage Medical Research Clinic|
|Calgary, Alberta, Canada, T2N 4Z6|
|Principal Investigator:||Lawrence M Korngut, MD, FRCPC||University of Calgary|