Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

• Status: Terminated
• Trial end date: 2008-04-02
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 1 diabetes

• HbA1c less than or equal to 11%

• Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

• Total daily insulin dosage more than 100 IU or U/day.

• Current smoking or smoking within the last 6 months

• Impaired hepatic or renal function

• Cardiac problems

• Uncontrolled hypertension

• Current proliferative retinopathy or maculopathy requiring acute treatment