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NCT00642616 · ClinicalTrials.gov registry record · Phase 3

Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease

A Phase 3 study, sponsored by Mannkind Corporation.

Terminated
Registry status
Phase 3
Development phase
34
Enrollment target

NCT00642616: Clinical Trial Phase 3 study, sponsored by Mannkind Corporation.

NCT00642616 is a Phase 3 study that was terminated before completion, run by Mannkind Corporation. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00642616, a Phase 3 study, was terminated before completion, sponsored by Mannkind Corporation.

TERMINATED
Registry status
Phase 3
Development phase
34 participants
Enrollment target

Study Summary

Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety

Primary Outcome

Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.

Interventions

  • DRUG Usual Care
  • DRUG Technosphere® Insulin

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2009-03
Est. Completion 2014-11
Phase Phase 3
Mannkind Corporation

42 total trials

Why NCT00642616 stopped before completion

NCT00642616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT00642616 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00642616 about?

NCT00642616 is a clinical study titled "Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease". Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety

What is the current status of trial NCT00642616?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2009-03. Estimated completion is 2014-11.

What interventions are being tested in trial NCT00642616?

The interventions under investigation include: Usual Care (DRUG), Technosphere® Insulin (DRUG).

Who is sponsoring clinical trial NCT00642616?

This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00642616's enrollment target sits among peer trials

34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00642616, the US trial registry maintained by the National Library of Medicine. NCT00642616 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.