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NCT01196104 · ClinicalTrials.gov registry record · Phase 3

Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

A Phase 3 study, sponsored by Mannkind Corporation.

Terminated
Registry status
Phase 3
Development phase
39
Enrollment target

NCT01196104: Clinical Trial Phase 3 study, sponsored by Mannkind Corporation.

NCT01196104 is a Phase 3 study that was terminated before completion, run by Mannkind Corporation. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01196104, a Phase 3 study, was terminated before completion, sponsored by Mannkind Corporation.

TERMINATED
Registry status
Phase 3
Development phase
39 participants
Enrollment target

Study Summary

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.

Primary Outcome

Change from Baseline in glycated hemoglobin at Week 16

Interventions

  • DRUG Insulin Glargine
  • DRUG Insulin Aspart
  • DRUG Technosphere® Insulin Inhalation Powder

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2010-09
Est. Completion 2012-03
Phase Phase 3
Mannkind Corporation

42 total trials

Why NCT01196104 stopped before completion

NCT01196104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which Insulin Glargine is the first listed.

NCT01196104 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01196104 about?

NCT01196104 is a clinical study titled "Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler". 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.

What is the current status of trial NCT01196104?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2010-09. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01196104?

The interventions under investigation include: Insulin Glargine (DRUG), Insulin Aspart (DRUG), Technosphere® Insulin Inhalation Powder (DRUG).

Who is sponsoring clinical trial NCT01196104?

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 NCT01196104's enrollment target sits among peer trials

39 1898th of 2000 higher than 101 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 NCT01196104, the US trial registry maintained by the National Library of Medicine. NCT01196104 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.