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NCT01451398 · ClinicalTrials.gov registry record · Phase 3
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
A Phase 3 study of Type 2 Diabetes, sponsored by Mannkind Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT01451398: Completed Phase 3 study of Type 2 Diabetes, sponsored by Mannkind Corporation.
NCT01451398 is a Phase 3 study of Type 2 Diabetes that has completed, run by Mannkind Corporation. The registered enrollment target is 353 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451398, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by Mannkind Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
Study Summary
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.
Primary Outcome
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
Conditions Studied
Interventions
- DRUG Technosphere® Insulin
- DRUG Technosphere Powder
Study Locations (20)
Florida
- - Hialeah
- - Hollywood
- - Miami
- - Miami
- - New Port Richey
- - North Miami Beach
- - Pembroke Pines
- - Pinellas Park
- - West Palm Beach
California
- - Anaheim
- - Huntington Beach
- - Laguna Hills
- - Long Beach
- - Los Angeles
- - Los Gatos
- - Tustin
- - West Hills
Georgia
- - Atlanta
- - Atlanta
- - Dunwoody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01451398 record still lists
NCT01451398 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Technosphere® Insulin is the first listed.
NCT01451398 names 20 study sites across 3 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01451398 about?
NCT01451398 is a clinical study titled "Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus". Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (plac...
What is the current status of trial NCT01451398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2011-11. Estimated completion is 2013-07.
What conditions does trial NCT01451398 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT01451398?
The interventions under investigation include: Technosphere® Insulin (DRUG), Technosphere Powder (DRUG).
Who is sponsoring clinical trial NCT01451398?
This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01451398 being conducted?
This trial has 20 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
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 NCT01451398's enrollment target sits among peer trials
353 57th of 327 higher than 270 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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
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