Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Pulmonary Safety in Diabetics with T/I

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• For All Subjects:

• Nonsmoking

• Body mass index <42 kg/m2

• FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,

• No abnormalities in screening pulmonary radiology

• For Subjects with diabetes mellitus:

• Type 1 or type 2 diabetes for at least 2 years

• HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %

• For Subjects without abnormalities in glucose control:

• No history of diabetes

• Normal results from a formal glucose tolerance test

Exclusion Criteria:

• History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease

• Significant renal, hepatic, or cardiac disease

• Women who are pregnant, lactating, or planning on becoming pregnant

• Subjects who have participated in studies of other investigational drugs within the previous 3 months

• Evidence of severe complications of diabetes