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Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
NCT01451398 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451398
The ClinicalTrials.gov registry entry for NCT01451398 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mannkind Corporation, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01451398 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01451398?
The interventions under investigation include: Technosphere® Insulin (DRUG), Technosphere Powder (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01451398?
This trial is sponsored by Mannkind Corporation, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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