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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: inhaled human insulin; Drug: insulin NPH; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00725036

NN1998-1496

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)