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A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

StatusCompleted
PhasePhase 4
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: 18 to 16 Site details revised at 8 of 62 sitesv36 Show 1 more changeShow less
    • Site details revised at 8 of 62 sites

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  2. Site details revised at 7 of 62 sitesv35
  3. Re-verified, no change to tracked fieldsv34
  4. Results first posted: Oct 21, 2009 Primary endpoint revised · Enrollment target: 260 to 261 · Interventions: Inhaled Human Insulin (Exubera) (Drug), Insulin Glargine (Lantus) (Drug) to Inhaled Human Insulin (Exubera®) (Drug), Insulin Glargine (Lantus®) (Drug) · 3 morev33 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 260 to 261
    • Interventions: Inhaled Human Insulin (Exubera) (Drug), Insulin Glargine (Lantus) (Drug) to Inhaled Human Insulin (Exubera®) (Drug), Insulin Glargine (Lantus®) (Drug)
    • Secondary endpoints: 5 to 18
    • Site details revised at 1 of 62 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: estimated 478 to confirmed 260v32
Show 30 earlier versionsHide 30 earlier versions
  1. Trial status: Active, Not Recruiting to Completed Study sites: 63 to 62 · Primary and study completion dates changed from estimate of Sep 2008 to Aug 2008v31 Show 2 more changesShow less
    • Study sites: 63 to 62
    • Primary and study completion dates changed from estimate of Sep 2008 to Aug 2008
  2. 3 versions Re-verified since Jun 11, 2008, no change to tracked fieldsv28-v30
  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Sep 2008 · Completion date: Jul 2008 to Sep 2008 · Site details revised at 63 of 63 sitesv27 Show 3 more changesShow less
    • Primary completion date: Sep 2008
    • Completion date: Jul 2008 to Sep 2008
    • Site details revised at 63 of 63 sites
  4. Site details revised at 9 of 63 sitesv26
  5. Site details revised at 12 of 63 sitesv25
  6. Site details revised at 6 of 63 sitesv24
  7. Site details revised at 10 of 63 sitesv23
  8. Site details revised at 5 of 63 sitesv22
  9. Study sites: 64 to 63v21
  10. Re-verified, no change to tracked fieldsv20
  11. Completion date: Jul 2008 Secondary endpoints: details revised at 5 of 5 entries · Site details revised at 31 of 64 sites · Study arms: 0 to 2 · 1 morev19 Show 4 more changesShow less
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 31 of 64 sites
    • Study arms: 0 to 2
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 5 of 64 sitesv18
  13. Site details revised at 11 of 64 sitesv17
  14. Site details revised at 48 of 64 sitesv16
  15. Study sites: 63 to 64v15
  16. Study sites: 64 to 63 Secondary endpoints revised (5)v14 Show 1 more changeShow less
    • Secondary endpoints revised (5)

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  17. Site details revised at 8 of 64 sitesv13
  18. Study sites: 61 to 64v12
  19. Study sites: 56 to 61 Secondary endpoints revised (5)v11 Show 1 more changeShow less
    • Secondary endpoints revised (5)

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  20. Study sites: 55 to 56 Secondary endpoints: 1 to 5v10 Show 1 more changeShow less
    • Secondary endpoints: 1 to 5

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  21. Study sites: 54 to 55v9
  22. Study sites: 48 to 54v8
  23. Study sites: 36 to 48v7
  24. Study sites: 10 to 36v6
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 5 to 10 · Start date: Jan 2007 to Dec 2006v5 Show 2 more changesShow less
    • Study sites: 5 to 10
    • Start date: Jan 2007 to Dec 2006
  26. Re-verified, no change to tracked fieldsv4
  27. Study sites: 0 to 5 Start date: Dec 2006 to Jan 2007v3 Show 1 more changeShow less
    • Start date: Dec 2006 to Jan 2007
  28. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
433 trials monitored
See 31 trials at risk
Diabetes
4,286 trials monitored
See 185 trials at risk
Type 2 Diabetes
2,100 trials monitored
See 101 trials at risk
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Trial Details
NCT Number NCT00391027
Lead Sponsor Pfizer
Conditions Diabetes Mellitus, Type 2
Enrollment 261 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov