Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Mannkind Corporation
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.
Research Team
Eligibility Criteria
Inclusion Criteria
Men and women ≥ 18 and ≤ 80 years of age
Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
Body mass index (BMI) ≤ 45 kg/m2
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Treatment Details
Interventions
- Technosphere® Insulin Inhalation Powder (Inhalation Powder)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Technosphere® Insulin Inhalation Powder (TI)Experimental Treatment2 Interventions
Insulin Glargine and Technosphere® Insulin Inhalation Powder
Group II: ComparatorActive Control2 Interventions
Insulin Glargine and Insulin Aspart
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Who Is Running the Clinical Trial?
Mannkind Corporation
Lead Sponsor
Trials
61
Recruited
8,400+
Michael E. Castagna
Mannkind Corporation
Chief Executive Officer since 2017
PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania
Burkhard Blank
Mannkind Corporation
Chief Medical Officer since 2021
MD