Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT01469559
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01469559
Study Brief:
Protocol Section:
NCT01469559