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

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) [ Time Frame: At 52 weeks ] [ Designated as safety issue: No ]
  

• Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% [ Time Frame: At 52 weeks ] [ Designated as 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 ] [ Designated as 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. ] [ Designated as safety issue: No ]
  
• Change From Baseline in FPG [ Time Frame: At 52 weeks or last observation ] [ Designated as safety issue: No ]
  
• Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
  
• Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
  
• Change From Baseline in Insulin Antibody Levels [ Time Frame: At weeks 24 and 52 or last observation. ] [ Designated as safety issue: No ]
  
• Change From Baseline in Body Weight [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ] [ Designated as safety issue: No ]
  
• Change From Baseline in Body Mass Index [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ] [ Designated as safety issue: No ]
  
• Change From Baseline in Basal Insulin Doses [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
  
• Change From Baseline in Prandial Insulin Doses [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
  
• Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) [ Time Frame: To 52 weeks. ] [ Designated as safety issue: No ]
  
• Change in Fasting Lipids From Baseline [ Time Frame: At weeks 24 and 52 or last observation ] [ Designated as safety issue: No ]
  

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.