A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months

• BMI <40 kg/m squared

• HbA1c greater than or equal to 7% and less than or equal to 11.5%

• Serum creatinine less than 2 for males and less than 1.8 for females

• Acceptable pulmonary function

Exclusion Criteria:

• Significant hepatic disease

• Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes