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 2

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00539396
• Lead Sponsor: Mannkind Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study Completion: 2005-12
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-12
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in blood glucose following a standard meal	0-300 minutes

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline HbA1c	week 12