A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

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

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 From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
  • Time Frame: At 52 weeks
    Safety Issue?: No

Secondary Measures

• Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%
  • Time Frame: At 52 weeks
    Safety Issue?: No
• Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%
  • Time Frame: At 52 weeks
    Safety Issue?: No
• Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline
  • Time Frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.
    Safety Issue?: No
• Change From Baseline in FPG
  • Time Frame: At 52 weeks or last observation
    Safety Issue?: No
• Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change From Baseline in Insulin Antibody Levels
  • Time Frame: At weeks 24 and 52 or last observation.
    Safety Issue?: No
• Change From Baseline in Body Weight
  • Time Frame: At weeks 12, 24, 36, and 52 or last observation.
    Safety Issue?: No
• Change From Baseline in Body Mass Index
  • Time Frame: At weeks 12, 24, 36, and 52 or last observation.
    Safety Issue?: No
• Change From Baseline in Basal Insulin Doses
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Change From Baseline in Prandial Insulin Doses
  • Time Frame: To 52 weeks
    Safety Issue?: No
• Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)
  • Time Frame: To 52 weeks.
    Safety Issue?: No
• Change in Fasting Lipids From Baseline
  • Time Frame: At weeks 24 and 52 or last observation
    Safety Issue?: No

Inclusion Criteria:

• Diabetes mellitus Type 1

Exclusion Criteria:

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease (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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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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