This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

StatusCompleted
PhasePhase 4
SponsorPfizer
Started

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Record History

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  1. Secondary endpoints: 19 to 18v26
  2. Re-verified, no change to tracked fieldsv25
  3. Eligibility criteria revisedv24
  4. Results first posted: Sep 4, 2009v23 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 415 to 413
    • Interventions: Inhaled Insulin (Exubera) (Drug), insulin glargine (Drug) to Inhaled Insulin (Exubera) (Drug), Insulin glargine (Drug)
    • Secondary endpoints: 15 to 19
    • Site details revised at 2 of 73 sites
  5. Start date: Feb 2007 to Mar 2007v22
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  1. Enrollment target: estimated 478 to confirmed 415v21
  2. Trial status: Recruiting to Completed
    • Study sites: 74 to 73
    • Secondary endpoints reordered
    v20
  3. Re-verified, no change to tracked fieldsv19
  4. Site details revised at 2 of 74 sitesv18
  5. Re-verified, no change to tracked fieldsv17
  6. Primary completion date: Aug 2008
    • Site details revised at 1 of 74 sites
    v16
  7. Re-verified, no change to tracked fieldsv15
  8. Eligibility criteria revised
    • Site details revised at 5 of 74 sites
    v14
  9. Eligibility criteria revisedv13
  10. Study completion date: Aug 2008v12 Show 4 more changesShow less
    • Interventions: Inhaled Insulin (Exubera) (Drug) to Inhaled Insulin (Exubera) (Drug), insulin glargine (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 15 of 15 entries
    • Study arms: 0 to 2
  11. Study sites: 72 to 74v11
  12. Study sites: 70 to 72v10
  13. Re-verified, no change to tracked fieldsv9
  14. Study sites: 55 to 70
    • Secondary endpoints: 5 to 15
    v8
  15. Study sites: 49 to 55
    • Eligibility criteria revised
    • Secondary endpoints: 15 to 5
    v7
  16. Study sites: 46 to 49
    • Secondary endpoints revised (15)
    v6
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 21 to 46
    v5
  18. Study sites: 0 to 21v4
  19. 2 versions Re-verified since Jan 16, 2007, no change to tracked fieldsv2-v3
  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
440 trials monitored
See 31 trials at risk
Diabetes
5,117 trials monitored
See 235 trials at risk
Type 2 Diabetes
2,245 trials monitored
See 115 trials at risk
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Trial Details
NCT Number NCT00418522
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2
Enrollment 413 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov