Safety Study of Intranasal Insulin in Type 1 Diabetes and Diabetic Peripheral Neuropathy

NCT01469559 | Completed Phase 2

• 1 other identifier: UCALG-IIDPN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 effective in slowing the progression of diabetic neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Insulin; Diabetic neuropathy; Intranasal administration; Pilot project

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia monitoring

  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.

  8 weeks

Secondary Outcomes (7)

• Treatment satisfaction questionnaire for medication (TSQM)

  6 weeks

• Adverse effects

  11 weeks

• The UTAH early neuropathy scale

  6 weeks

• Corneal confocal microscopy

  6 weeks

• Electrophysiology

  6 weeks

Study Arms (2)

Novolin Toronto insulin

ACTIVE COMPARATOR

Drug: Novolin Toronto insulin

Normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Novolin Toronto insulin DRUG

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.

Novolin Toronto insulin

Normal saline DRUG

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 .

Normal saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetic Neuropathies

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lawrence M Korngut, MD, FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Neurologist

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

CA (1)