Back to resultsA 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
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Technosphere Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in blood glucose following a standard meal
Secondary Outcome Measures
Mean change from baseline HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00539396
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mannkind Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin
Primary Outcome Measure Information:
Title
Change in blood glucose following a standard meal
Time Frame
0-300 minutes
Secondary Outcome Measure Information:
Title
Mean change from baseline HbA1c
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Baughman, PhD
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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