CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 288 enrolled
Drug / intervention
Inhaled Insulin +1 moredrug
Likely dose
Inhaled insulin with dose adjusted according to premeal blood glucose, combined with oral antidiabetic agent(s) and/or basal insulin (Ultralente, NPH, or insulin glargine); or subcutaneous short-acting insulin with similar dose adjustment and basal regimenAI-extracted
Key inclusion· 2
  • ✓Type 1 or Type 2 Diabetes Mellitus currently controlled with injected insulin
  • ✓Mild intermittent or mild to moderate persistent asthma
Key exclusion· 3
  • ✕Poorly controlled, unstable, or steroid-dependent asthma
  • ✕Current insulin pump therapy
  • ✕Active smoking

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00139659
NCT00139659Phase 3Completed
CompareCT.gov

Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial

Pfizer·interventional·Posted Aug 31, 2005·Updated Jun 2, 2010

In Brief

A Phase 3 clinical trial evaluating Inhaled Insulin and Subcutaneous Insulin for Asthma and Diabetes Mellitus. Completed, enrolled 288 participants across 102 sites in 5 countries.

Detailed Summary

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Diabetes Mellitus
CountriesBrazil, Canada, Costa Rica, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2005
Enrollment StartJan 1, 2003
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Inhaled Insulindrug

Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.

Subcutaneous Insulindrug

Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.