Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
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ClinicalTrials.gov Identifier: NCT01445951 |
Recruitment Status :
Completed
First Posted : October 4, 2011
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
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Sponsor:
Mannkind Corporation
Information provided by (Responsible Party):
Mannkind Corporation
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Tracking Information | |||
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First Submitted Date ICMJE | September 30, 2011 | ||
First Posted Date ICMJE | October 4, 2011 | ||
Results First Submitted Date ICMJE | July 22, 2014 | ||
Results First Posted Date ICMJE | October 22, 2014 | ||
Last Update Posted Date | October 22, 2014 | ||
Study Start Date ICMJE | September 2011 | ||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Change From Baseline to Week 24 in HbA1c [ Time Frame: Baseline to Week 24 ] Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24
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Original Primary Outcome Measures ICMJE |
Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 weeks ] Change in HbA1c baseline
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period | ||
Official Title ICMJE | A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period | ||
Brief Summary | Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin | ||
Detailed Description | Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Type 1 Diabetes Mellitus | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
518 | ||
Original Estimated Enrollment ICMJE |
471 | ||
Actual Study Completion Date ICMJE | June 2013 | ||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Brazil, Russian Federation, Ukraine, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01445951 | ||
Other Study ID Numbers ICMJE | MKC-TI-171 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Mannkind Corporation | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Mannkind Corporation | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Mannkind Corporation | ||
Verification Date | October 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |