Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01445951 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Mannkind Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
- 20
- Study locations
NCT01445951: Completed Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Mannkind Corporation.
NCT01445951 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by Mannkind Corporation. The registered enrollment target is 518 participants, above the 167-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (210% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445951, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by Mannkind Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Technosphere® Insulin with MedTone C Inhaler
- DRUG Technosphere ®Insulin with Gen2 Inhaler
- DRUG Insulin Aspart in combination with a basal insulin
Study Locations (20)
California
- - Burlingame
- - Escondido
- - Huntington Beach
- - La Jolla
- - La Mesa
- - Long Beach
- - Los Angeles
- - Los Angeles
- - Los Gatos
- - San Mateo
- - Santa Barbara
- - Tustin
Florida
- - Hialeah
- - Hollywood
- - Miami
- - Miami
- - New Port Richey
- - Palm Harbor
- - West Palm Beach
Colorado
- - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01445951 record still lists
NCT01445951 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (210% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Technosphere® Insulin with MedTone C Inhaler is the first listed.
NCT01445951 names 20 study sites across 3 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01445951 about?
NCT01445951 is a clinical study titled "Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period". 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
What is the current status of trial NCT01445951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2011-09. Estimated completion is 2013-06.
What conditions does trial NCT01445951 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01445951?
The interventions under investigation include: Technosphere® Insulin with MedTone C Inhaler (DRUG), Technosphere ®Insulin with Gen2 Inhaler (DRUG), Insulin Aspart in combination with a basal insulin (DRUG).
Who is sponsoring clinical trial NCT01445951?
This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01445951 being conducted?
This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01445951's enrollment target sits among peer trials
518 8th of 112 higher than 105 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
RECRUITING · Phase 3
-
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
ACTIVE NOT RECRUITING · Phase 3
-
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
ACTIVE NOT RECRUITING · Phase 3
-
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
COMPLETED · Phase 3
-
Pediatric Diabetics Type 1 Using InsuPatch
COMPLETED · Phase 3
-
Efficacy of Islet After Kidney Transplantation
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04524871 · 518 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
- NCT07112196 · 518 participants · Phase 2
Visugromab in Cachexia International Trial
- NCT05676450 · 517 participants · NA
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
- NCT02323581 · 520 participants · NA
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia