Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

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

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of type 1 diabetes for at least 1 year

• Nonsmokers for prior 6 months

• BMI less than or equal to 35kg/m2

• HbA1c > or = 7% and < or = 11%

• Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects

• FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted

• Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day

• Urine cotinine < or = 100 ng/mL

Exclusion Criteria:

• History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings

• Evidence of severe complications of diabetes

• Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal