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

Amendment history

1. Jul 20, 2026

   Minor

   Secondary endpoints: 19 to 18

   Show what changed: Secondary endpoints

   Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire

   Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats · v26

2. Aug 31, 2018

   Minor

   Study Status, Sponsor/Collaborators, Outcome Measures (Results)

   Re-verified, no change to tracked fields

   v25

3. Sep 8, 2009

   Minor

   Eligibility criteria revised

   Show what changed: Eligibility criteria

   [...] h an insulin regimen (alone or with Oral Antidiabetic Agents, OAs) Active liver disease; significantly-impaired hepatic funct [...] mal as measured at visit 1. However, patients with elevated alanine aminotransferase (ALT) >1.5 UNLupper limit of normal as a result of hepatic steatosis are permitted to enter the study.

   Study Status, Eligibility · v24

4. Jul 30, 2009

   Notable

   Results first posted: Sep 4, 2009

   Primary endpoint revised; Enrollment target: 415 to 413; Interventions: Inhaled Insulin (Exubera) (Drug), insulin glargine (Drug) to Inhaled Insulin (Exubera) (Drug), Insulin glargine (Drug); and 2 more

   Show all 6 changes in this update

   • Notable Results first posted: Sep 4, 2009
   • Notable Primary endpoint revised
     Show what changed

     DemonstrateChange non-inferiorityFrom of dry powder inhaled insulin (EXUBERA) compared to insulin glargine (LANTUS)Baseline in termsGlycosylated ofHemoglobin glycemic controlA1c (HbA1c) afterat Week 26 weeksfor ofthe treatmentPer Protocol (PP) Population
   • Minor Enrollment target: 415 to 413
   • Minor Interventions: Inhaled Insulin (Exubera) (Drug), insulin glargine (Drug) to Inhaled Insulin (Exubera) (Drug), Insulin glargine (Drug)
   • Minor Secondary endpoints: 15 to 19
     Show what changed

     Secondary endpoints include the following at week 26: ProportionPercentage of patientsSubjects achievingAchieving Glycemic Control (HbA1c < 6.5%) at Week 26 IncidencePercentage of clinicalSubjects adverseAchieving events ProportionGlycemic ofControl patients achieving (HbA1c < 7.0%) at Week 26 Change from baseline in fasting plasma glucose level Change from baseline in postprandial blood glucose excursions as measured by 8-point profiles and as determined by standardized meal tolerance tests ProportionPercentage of patientsSubjects achievingAchieving Glycemic Control (HbA1c < 8.0%) at Week 26 [...] [...]
   • Minor Site details revised at 2 of 73 sites

   Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information · v23

5. Feb 26, 2009

   Minor

   Start date: Feb 2007 to Mar 2007

   Study Status · v22

25. Jan 4, 2007

    Minor

    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.