Official Title: “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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Inhaled Human Insulin (Exubera)
  • Preprandial inhaled insulin regimen and administration of insulin glargine QD
• Drug: Insulin lispro (Humalog)
  • Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Control
• Experimental: Experimental

Primary Measures

• Change of glycosylated hemoglobin from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: No

Secondary Measures

• Change in glycosylated hemoglobin from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Incidence of Hypoglycemia from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: Yes
• Change in lipids from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change in insulin antibody titers from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change in glucose disposition from baseline
  • Time Frame: To 24 weeks
    Safety Issue?: No
• Change in diurnal glycemic excursions from baseline
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change in quality of life from baseline
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Diabetes mellitus Type 1

Exclusion Criteria:

• Severe Asthma, severe COPD
• Smoking

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356421

Study ID Number: A2171035

ClinicalTrials.gov Identifier: NCT00356421

Health Authority: United States: Food and Drug Administration

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