Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 340 subjects were planned to be randomized; 87 were screened and 58 were randomized to study treatment prior to study termination.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.

Reporting Groups

	Description
Exubera ®	Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
Insulin Lispro	Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.

Participant Flow:   Overall Study

	Exubera ®	Insulin Lispro
STARTED	38	20
COMPLETED	6	3
NOT COMPLETED	32	17
Lack of Efficacy	3	0
Withdrawal by Subject	9	2
Related to study drug	15	12
Not related to study drug	5	3

Reporting Groups

	Description
Exubera ®	Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
Insulin Lispro	Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.

Baseline Measures

	Exubera ®	Insulin Lispro	Total
Number of Participants   [units: participants]	38	20	58
Age, Customized[1] [units: participants]
18 - 44 years	22	13	35
45 - 64 years	14	6	20
>=65 years	2	1	3
Gender   [units: participants]
Female	17	6	23
Male	21	14	35

1.  Primary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)   [ At 52 weeks ]

2.  Secondary:

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%   [ At 52 weeks ]

3.  Secondary:

Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%   [ At 52 weeks ]

4.  Secondary:

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   [ At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. ]

5.  Secondary:

Change From Baseline in FPG   [ At 52 weeks or last observation ]

6.  Secondary:

Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments   [ To 52 weeks ]

7.  Secondary:

Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments   [ To 52 weeks ]

8.  Secondary:

Change From Baseline in Insulin Antibody Levels   [ At weeks 24 and 52 or last observation. ]

9.  Secondary:

Change From Baseline in Body Weight   [ At weeks 12, 24, 36, and 52 or last observation. ]

10.  Secondary:

Change From Baseline in Body Mass Index   [ At weeks 12, 24, 36, and 52 or last observation. ]

11.  Secondary:

Change From Baseline in Basal Insulin Doses   [ To 52 weeks ]

12.  Secondary:

Change From Baseline in Prandial Insulin Doses   [ To 52 weeks ]

13.  Secondary:

Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)   [ To 52 weeks. ]

14.  Secondary:

Change in Fasting Lipids From Baseline   [ At weeks 24 and 52 or last observation ]

15.  Other Pre-specified:

Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire   [ At weeks 6, 24, and 52 or last observation ]

16.  Other Pre-specified:

Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement   [ At weeks 6, 24, and 52 or last observation ]