| A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog® |
| A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus |
| To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus |
| Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination. |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Diabetes Mellitus, Type 1 |
|
|
|
|
| Not Provided |
| |
| Terminated |
| 58 |
| June 2008 |
| June 2008 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
Exclusion Criteria:
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
- Smoking
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Belgium, Denmark, Finland, France, Ireland, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, United States |
| Germany |
| |
| NCT00356421 |
| A2171035 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| January 2009 |
