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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539396
• Other study ID #: MKC-TI-101
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2007
• Last updated: October 12, 2009
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: October 2009
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Technosphere Insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose following a standard meal		0-300 minutes
Secondary	Mean change from baseline HbA1c		week 12