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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Insulin; Insulin, Globin Zinc

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.