Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents

• Change From Baseline in Other PFT Parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Change From Baseline in FVC [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin; [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Hypoglycemic Event Rates; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Treatment Preferences. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Slope for Other PFT Parameters; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Change From Baseline in Insulin Antibodies (microU/mL); [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• 7 Point Home Glucose [ Time Frame: 12 months ] [ Designated as safety issue: No ]

• Change from baseline in FVC
• Change from baseline in other PFT parameters
• Slope from Baseline to Week 52 and slope from Week 12 to Week 52 for FEV1 and FVC as a percent of predicted;
• Slope for other PFT parameters;
• Proportion of subjects achieving ADA age appropriate guidelines for HbA1c
• Change from baseline in insulin antibodies (microU/mL);
• Change from baseline in body weight (kg), height (cm), and Body Mass Index (BMI; kg/m2) and z score (%);Dose of insulin;
• Hypoglycemic event rates;
• 7 Point Home Glucose
• Treatment preferences

To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, 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 A2171083 was terminated and no further recruitment took place.

• Drug: Inhaled insulin (Exubera)
  Inhaled insulin with dose adjusted according to premeal blood glucose
• Drug: Subcutaneous Insulin (subject's prescribed)
  Subcutaneous insulin with dose adjusted according to premeal blood glucose

• Experimental: Inhaled insulin (Exubera)
  Intervention: Drug: Inhaled insulin (Exubera)
• Active Comparator: Subcutaneous Insulin (subject's prescribed)
  Intervention: Drug: Subcutaneous Insulin (subject's prescribed)

Inclusion Criteria:

• Subjects with Type 1 diabetes mellitus for more than 6 months.
• Males and females ages 6 to 17 years.
• Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.

Exclusion Criteria:

• Subjects using an insulin pump
• Smoking