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

StatusCompleted
PhasePhase 4
SponsorPfizer
Started

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Record History

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  1. Secondary endpoints: 18 to 16
    • Site details revised at 8 of 62 sites
    v36
  2. Site details revised at 7 of 62 sitesv35
  3. Re-verified, no change to tracked fieldsv34
  4. Results first posted: Oct 21, 2009v33 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
  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 2008
    v31
  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
    • Study completion date: Jul 2008 to Sep 2008
    • Site details revised at 63 of 63 sites
    v27
  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. Study completion date: Jul 2008v19 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
  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
  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
  20. Study sites: 55 to 56
    • Secondary endpoints: 1 to 5
    v10
  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 2006
    v5
  26. Re-verified, no change to tracked fieldsv4
  27. Study sites: 0 to 5
    • Start date: Dec 2006 to Jan 2007
    v3
  28. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
441 trials monitored
See 31 trials at risk
Diabetes
5,141 trials monitored
See 246 trials at risk
Type 2 Diabetes
2,257 trials monitored
See 120 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
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Insulin Resistance
Enrollment 261 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov