Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2004-12-14
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 1 diabetes

• Current treatment with any insulin in any regimen

• Body mass index (BMI) below 38.0 kg/m2

• HbA1c below or equal to 13.0%

Exclusion Criteria:

• Total daily insulin dosage more than 100 IU/day

• Current acute or chronic pulmonary disease (excluding asthma)

• Recurrent major hypoglycaemia

• Proliferative retinopathy or maculopathy requiring acute treatment

• Smoker

• Chest X-ray with clinically significant abnormalities