Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

A Phase 3b, Randomized, Open-Label, Parallel Group, Multicenter Trial Assessing The Efficacy Of Exubera Vs. Lispro Introduced Into A Lantus Based Regimen In Suboptimally Controlled Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348374

Enrollment

191

Registered

2006-07-04

Start date

2006-06-30

Completion date

2008-08-31

Last updated

2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

type two diabetes, insulin, HbA1c

Brief summary

The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.

Interventions

DRUGInsulin Lispro

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

DRUGExubera

Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

Exclusion criteria

* lung disease * current smoking or discontinued smoking within past 6 months

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment	Baseline, Week 24 (End of Treatment)	Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.

Secondary

Measure	Time frame	Description
Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	Week 24	Number of subjects acheiving glycemic control: HbA1c target levels of \<7.0%, \<6.5%, and \<6.0% at Week 24.
Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	Week 24	Number of subjects that attained HbA1c target levels of \<7%, \< 6.5%,and \<6.0% at Week 24 without an episode of severe hypoglycemia.
Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.
Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	Baseline, Week 12	Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.
Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	Baseline, Week 24	Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.
Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Baseline, Week 12, Week 24	Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.
Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests	Week 12, Week 24	Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)\[mg/L\], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.
Change From Baseline Weight at Each Visit	Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	Change = mean body weight at observation minus mean body weight at Baseline.
Change From Baseline in Fasting Plasma Lipids	Baseline, Week 12, Week 24	Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	Dose of inhaled insulin prior to each meal at each visit.
Number of Subjects With Hypoglycemic Events	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.
Number of Total Hypoglycemic Events	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.
Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated \* days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.
Crude Hypoglycemic Event Rate	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.
Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)	Week 4, Week 24	Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.
Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24	Week 4, Week 24	Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24.
Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Baseline, Week 12, Week 24	Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.
Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Baseline, Week 12, Week 24	Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.
Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).

Countries

Puerto Rico, United States

Participant flow

Recruitment details

Participants were recruited from 62 centers between June 2006 and August 2008.

Participants by arm

Arm	Count
Exubera® Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day \[TID\]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.	88
Insulin Lispro Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses \[before breakfast, lunch, and dinner\], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).	96
Total	184

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	4
Overall Study	Lost to Follow-up	1	3
Overall Study	ongoing at date of cutoff	1	1
Overall Study	Other	11	12
Overall Study	randomized but did not receive treatment	0	7
Overall Study	Withdrawal by Subject	5	5

Baseline characteristics

Characteristic	Exubera®	Insulin Lispro	Total
Age, Customized 18-44 years	16 participants	19 participants	35 participants
Age, Customized 45-64 years	56 participants	51 participants	107 participants
Age, Customized >=65 years	16 participants	26 participants	42 participants
Sex: Female, Male Female	37 Participants	37 Participants	74 Participants
Sex: Female, Male Male	51 Participants	59 Participants	110 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	68 / 88	67 / 96
serious Total, serious adverse events	3 / 88	3 / 96

Outcome results

Primary

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment

Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.

Time frame: Baseline, Week 24 (End of Treatment)

Population: Full analysis set (FAS): subjects who received at least one dose of study medication, had a baseline glycosylated hemoglobin A1c (HbA1c%) measurement, and had a post-baseline HbA1C measurement; last (post-baseline) observation carried forward (LOCF). Number of subjects with HbA1c values at Baseline and Week 24: Exubera® n=81, Lispro n=90.

Arm	Measure	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment	-1.4 percent	Standard Deviation 1.3
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment	-1.6 percent	Standard Deviation 1

Secondary

Baseline Prandial Insulin Dose (at Each Meal) at Each Visit

Dose of inhaled insulin prior to each meal at each visit.

Time frame: Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 0: Pre-breakfast (n=81)	4.14 mg	Standard Deviation 1.39
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 0: Pre-lunch (n=86)	4.10 mg	Standard Deviation 1.37
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 0: Pre-dinner (n=87)	4.06 mg	Standard Deviation 1.33
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 1: Pre-breakfast (n=87)	4.25 mg	Standard Deviation 1.45
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 1: Pre-lunch (n=87)	4.33 mg	Standard Deviation 1.42
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 1: Pre-dinner (n=87)	4.35 mg	Standard Deviation 1.49
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 2: Pre-breakfast (n=87)	4.89 mg	Standard Deviation 1.63
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 2: Pre-lunch (n=87)	4.94 mg	Standard Deviation 1.72
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 2: Pre-dinner (n=87)	5.09 mg	Standard Deviation 1.82
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 4: Pre-breakfast (n=84)	5.44 mg	Standard Deviation 2.16
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 4: Pre-lunch (n=84)	5.46 mg	Standard Deviation 2.32
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 4: Pre-dinner (n=84)	5.71 mg	Standard Deviation 2.36
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 8: Pre-breakfast (n=80)	6.09 mg	Standard Deviation 2.93
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 8: Pre-lunch (n=80)	6.11 mg	Standard Deviation 2.99
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 8: Pre-dinner (n=80)	6.41 mg	Standard Deviation 3.07
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 12: Pre-breakfast (n=74)	6.40 mg	Standard Deviation 3.17
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 12: Pre-lunch (n=74)	6.51 mg	Standard Deviation 3.35
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 12: Pre-dinner (n=74)	7.01 mg	Standard Deviation 3.67
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 16: Pre-breakfast (n=71)	6.69 mg	Standard Deviation 3.6
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 16: Pre-lunch (n=71)	6.78 mg	Standard Deviation 3.82
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 16: Pre-dinner (n=71)	7.40 mg	Standard Deviation 4.04
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 20: Pre-breakfast (n=68)	7.01 mg	Standard Deviation 4.06
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 20: Pre-lunch (n=68)	7.10 mg	Standard Deviation 4.2
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 20: Pre-dinner (n=68)	7.58 mg	Standard Deviation 4.3
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 24: Pre-breakfast (n=66)	7.53 mg	Standard Deviation 4.78
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 24: Pre-lunch (n=66)	7.70 mg	Standard Deviation 4.69
Exubera®	Baseline Prandial Insulin Dose (at Each Meal) at Each Visit	Week 24: Pre-dinner (n=66)	7.83 mg	Standard Deviation 4.81

Secondary

Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)

Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.

Time frame: Baseline, Week 12, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 12 (n=19, 16)	-30.4 mg/dL	Standard Deviation 44.3
Exubera®	Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 24 (n=17, 13)	-19.4 mg/dL	Standard Deviation 43.7
Insulin Lispro	Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 12 (n=19, 16)	-33.0 mg/dL	Standard Deviation 41.9
Insulin Lispro	Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 24 (n=17, 13)	-23.4 mg/dL	Standard Deviation 43.1

Secondary

Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles

Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.

Time frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: Pre-Breakfast [fasting] (n=66, 73)	-2.5 mg/dL	Standard Deviation 52.6
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Breakfast (n=62, 72)	-36.3 mg/dL	Standard Deviation 78.9
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Lunch (n=62, 73)	-32.2 mg/dL	Standard Deviation 76.2
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Supper (n=61, 68)	-30.7 mg/dL	Standard Deviation 74.6
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: Pre-Breakfast [fasting] (n=66, 69)	5.7 mg/dL	Standard Deviation 53.5
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Breakfast (n=58, 68)	-43.7 mg/dL	Standard Deviation 80.7
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Lunch (n=59, 69)	-28.1 mg/dL	Standard Deviation 73.4
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Supper (n=62, 67)	-32.6 mg/dL	Standard Deviation 80
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: Pre-Breakfast [fasting] (n=67, 74)	11.1 mg/dL	Standard Deviation 54.1
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Breakfast (n=62, 68)	-50.0 mg/dL	Standard Deviation 85
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Lunch (n=60, 74)	-45.8 mg/dL	Standard Deviation 80.1
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Supper (n=57, 70)	-44.9 mg/dL	Standard Deviation 85.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: Pre-Breakfast [fasting] (n=67, 69)	-6.7 mg/dL	Standard Deviation 67
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Breakfast (n=61, 69)	-50.2 mg/dL	Standard Deviation 89.8
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Lunch (n=60, 69)	-42.9 mg/dL	Standard Deviation 78.5
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Supper (n=60, 68)	-45.1 mg/dL	Standard Deviation 87.8
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: Pre-Breakfast [fasting] (n=57, 73)	-12.2 mg/dL	Standard Deviation 63.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Breakfast (n=51, 70)	-46.8 mg/dL	Standard Deviation 81.1
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Lunch (n=49, 71)	-49.1 mg/dL	Standard Deviation 87.6
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Supper (n=52, 69)	-48.2 mg/dL	Standard Deviation 84.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: Pre-Breakfast [fasting] (n=55, 66)	-26.1 mg/dL	Standard Deviation 59.9
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Breakfast (n=50, 65)	-55.2 mg/dL	Standard Deviation 81.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Lunch (n=50, 65)	-56.0 mg/dL	Standard Deviation 74.9
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Supper (n=51, 61)	-53.4 mg/dL	Standard Deviation 83.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: Pre-Breakfast [fasting] (n=57, 60)	-25.4 mg/dL	Standard Deviation 60.7
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Breakfast (n=51, 59)	-64.2 mg/dL	Standard Deviation 67.3
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Lunch (n=51, 60)	-50.7 mg/dL	Standard Deviation 71.1
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Supper (n=50, 55)	-62.4 mg/dL	Standard Deviation 73.4
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: Pre-Breakfast [fasting] (n=56, 55)	-26.6 mg/dL	Standard Deviation 64.7
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Breakfast (n=51, 55)	-61.8 mg/dL	Standard Deviation 69.5
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Lunch (n=50, 56)	-59.6 mg/dL	Standard Deviation 69.9
Exubera®	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Supper (n=52, 54)	-58.1 mg/dL	Standard Deviation 73.2
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Supper (n=52, 54)	-78.0 mg/dL	Standard Deviation 82.2
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: Pre-Breakfast [fasting] (n=67, 74)	9.3 mg/dL	Standard Deviation 54.3
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: Pre-Breakfast [fasting] (n=57, 73)	-22.2 mg/dL	Standard Deviation 63
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Breakfast (n=62, 72)	-19.3 mg/dL	Standard Deviation 77.5
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: Pre-Breakfast [fasting] (n=57, 60)	-26.3 mg/dL	Standard Deviation 59.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Lunch (n=62, 73)	-27.9 mg/dL	Standard Deviation 84.2
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Breakfast (n=51, 70)	-74.8 mg/dL	Standard Deviation 84.3
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 1: 2 Hours Post-Supper (n=61, 68)	-32.5 mg/dL	Standard Deviation 89.5
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: Pre-Breakfast [fasting] (n=56, 55)	-27.6 mg/dL	Standard Deviation 43.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: Pre-Breakfast [fasting] (n=66, 69)	5.5 mg/dL	Standard Deviation 58.4
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Lunch (n=49, 71)	-60.6 mg/dL	Standard Deviation 98.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Breakfast (n=58, 68)	-40.8 mg/dL	Standard Deviation 99.3
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Breakfast (n=51, 59)	-78.5 mg/dL	Standard Deviation 70.7
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Lunch (n=59, 69)	-52.0 mg/dL	Standard Deviation 92
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 12: 2 Hours Post-Supper (n=52, 69)	-81.6 mg/dL	Standard Deviation 81.5
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 2: 2 Hours Post-Supper (n=62, 67)	-54.3 mg/dL	Standard Deviation 84.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Lunch (n=50, 56)	-65.5 mg/dL	Standard Deviation 94
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: Pre-Breakfast [fasting] (n=66, 73)	-4.3 mg/dL	Standard Deviation 61.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: Pre-Breakfast [fasting] (n=55, 66)	-16.9 mg/dL	Standard Deviation 62
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Breakfast (n=62, 68)	-48.5 mg/dL	Standard Deviation 87
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Lunch (n=51, 60)	-74.1 mg/dL	Standard Deviation 91.5
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Lunch (n=60, 74)	-52.4 mg/dL	Standard Deviation 96
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Breakfast (n=50, 65)	-60.5 mg/dL	Standard Deviation 81.7
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 4: 2 Hours Post-Supper (n=57, 70)	-71.5 mg/dL	Standard Deviation 99
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 24: 2 Hours Post-Breakfast (n=51, 55)	-75.1 mg/dL	Standard Deviation 66.3
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: Pre-Breakfast [fasting] (n=67, 69)	-20.8 mg/dL	Standard Deviation 48.6
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Lunch (n=50, 65)	-69.9 mg/dL	Standard Deviation 99.2
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Breakfast (n=61, 69)	-59.0 mg/dL	Standard Deviation 78.8
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 20: 2 Hours Post-Supper (n=50, 55)	-78.7 mg/dL	Standard Deviation 83.9
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Lunch (n=60, 69)	-61.0 mg/dL	Standard Deviation 95.7
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 16: 2 Hours Post-Supper (n=51, 61)	-90.6 mg/dL	Standard Deviation 96.1
Insulin Lispro	Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles	Week 8: 2 Hours Post-Supper (n=60, 68)	-86.5 mg/dL	Standard Deviation 98.5

Secondary

Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests

Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.

Time frame: Baseline, Week 12, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 24: Postprandial (n=17, 21)	-9.5 mg/dL	Standard Deviation 45.9
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 12 Postprandial(n=22, 33)	-6.8 mg/dL	Standard Deviation 14.8
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol Week 24 Postprandial(n=17, 21)	0.7 mg/dL	Standard Deviation 34.3
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Fasting (n=60, 79)	1.2 mg/dL	Standard Deviation 4.5
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Postprandial (n=22, 33)	1.3 mg/dL	Standard Deviation 3.5
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 24 Fasting (n=51, 59)	1.1 mg/dL	Standard Deviation 5.2
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 12 Fasting (n=60, 79)	1.3 mg/dL	Standard Deviation 19.8
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 12 Postprandial (n=22, 33)	-1.4 mg/dL	Standard Deviation 13.3
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 24 Fasting (n=51, 59)	3.5 mg/dL	Standard Deviation 27
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 24 Postprandial (n=17, 21)	2.5 mg/dL	Standard Deviation 31.3
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 12: Fasting (n=60, 79)	-34.7 mg/dL	Standard Deviation 59.3
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 24 Fasting (n=51, 59)	-0.2 mg/dL	Standard Deviation 31.7
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Postprandial (n=17, 21)	0.0 mg/dL	Standard Deviation 5.7
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 12 : Postprandial (n=22, 33)	-34.1 mg/dL	Standard Deviation 42.8
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 24: Fasting (n=51, 59)	-24.3 mg/dL	Standard Deviation 59.3
Exubera®	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 12 Fasting (n=60, 79)	-4.4 mg/dL	Standard Deviation 21.1
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 24: Fasting (n=51, 59)	-24.9 mg/dL	Standard Deviation 98.4
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 12 Fasting (n=60, 79)	1.2 mg/dL	Standard Deviation 34.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 24 Fasting (n=51, 59)	5.0 mg/dL	Standard Deviation 23.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 24 Fasting (n=51, 59)	0.5 mg/dL	Standard Deviation 29.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol Week 24 Postprandial(n=17, 21)	-4.7 mg/dL	Standard Deviation 29.5
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 24 Postprandial (n=17, 21)	-0.7 mg/dL	Standard Deviation 19.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Fasting (n=60, 79)	1.4 mg/dL	Standard Deviation 5.5
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 12 : Postprandial (n=22, 33)	-31.6 mg/dL	Standard Deviation 71.4
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Postprandial (n=22, 33)	1.1 mg/dL	Standard Deviation 5.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 12: Fasting (n=60, 79)	-30.7 mg/dL	Standard Deviation 74.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 24 Fasting (n=51, 59)	0.4 mg/dL	Standard Deviation 5.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	HDL cholesterol: Week 12 Postprandial (n=17, 21)	-0.4 mg/dL	Standard Deviation 6
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Triglycerides: Week 24: Postprandial (n=17, 21)	-17.9 mg/dL	Standard Deviation 89
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 12 Fasting (n=60, 79)	5.9 mg/dL	Standard Deviation 29.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	Total cholesterol: Week 12 Postprandial(n=22, 33)	-6.7 mg/dL	Standard Deviation 31.2
Insulin Lispro	Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests	LDL cholesterol: Week 12 Postprandial (n=22, 33)	-1.5 mg/dL	Standard Deviation 26.8

Secondary

Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12

Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.

Time frame: Baseline, Week 12

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	90 mins (n=25, 38)	-62.8 mg/dL	Standard Deviation 73.5
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	180 mins (n=26, 37)	-49.1 mg/dL	Standard Deviation 79.1
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	60 mins (n=23, 35)	-58.8 mg/dL	Standard Deviation 75.1
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	0 mins (Fasting) (n=25, 42)	-49.8 mg/dL	Standard Deviation 68.6
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	120 mins (n=26, 40)	-56.3 mg/dL	Standard Deviation 71.5
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	30 mins (n=6, 6)	-27.9 mg/dL	Standard Deviation 65.4
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	120 mins (n=26, 40)	-77.4 mg/dL	Standard Deviation 68.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	60 mins (n=23, 35)	-50.3 mg/dL	Standard Deviation 73.2
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	90 mins (n=25, 38)	-69.5 mg/dL	Standard Deviation 65.7
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	30 mins (n=6, 6)	-44.4 mg/dL	Standard Deviation 33.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	180 mins (n=26, 37)	-76.4 mg/dL	Standard Deviation 68.8
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12	0 mins (Fasting) (n=25, 42)	-30.5 mg/dL	Standard Deviation 58.2

Secondary

Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24

Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.

Time frame: Baseline, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	0 mins (Fasting) (n=22, 30)	-25.1 mg/dL	Standard Deviation 109.5
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	30 mins (n=1, 7)	-59.5 mg/dL	Standard Deviation 0
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	90 mins (n=22, 28)	-72.1 mg/dL	Standard Deviation 98.9
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	120 mins (n=23, 29)	-74.2 mg/dL	Standard Deviation 95
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	180 mins (n=21, 28)	-64.1 mg/dL	Standard Deviation 95.9
Exubera®	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	60 mins (n=21, 26)	-64.9 mg/dL	Standard Deviation 107.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	180 mins (n=21, 28)	-74.2 mg/dL	Standard Deviation 66.2
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	0 mins (Fasting) (n=22, 30)	-34.8 mg/dL	Standard Deviation 64.3
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	120 mins (n=23, 29)	-75.7 mg/dL	Standard Deviation 59.7
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	30 mins (n=1, 7)	-86.0 mg/dL	Standard Deviation 43.5
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	60 mins (n=21, 26)	-59.8 mg/dL	Standard Deviation 61.9
Insulin Lispro	Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24	90 mins (n=22, 28)	-73.6 mg/dL	Standard Deviation 54

Secondary

Change From Baseline in Fasting Plasma Lipids

Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.

Time frame: Baseline, Week 12, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Fasting Plasma Lipids	Total cholesterol: Week 12 (n=60, 79)	-4.4 mg/dL	Standard Deviation 21.1
Exubera®	Change From Baseline in Fasting Plasma Lipids	Total cholesterol: Week 24 (n=51, 59)	-0.2 mg/dL	Standard Deviation 31.7
Exubera®	Change From Baseline in Fasting Plasma Lipids	HDL cholesterol: Week 12 (n=60, 79)	1.2 mg/dL	Standard Deviation 4.5
Exubera®	Change From Baseline in Fasting Plasma Lipids	HDL cholesterol: Week 24 (n=51, 59)	1.1 mg/dL	Standard Deviation 5.2
Exubera®	Change From Baseline in Fasting Plasma Lipids	LDL cholesterol: Week 12 (n=60, 79)	1.3 mg/dL	Standard Deviation 19.8
Exubera®	Change From Baseline in Fasting Plasma Lipids	LDL cholesterol: Week 24 (n=51, 59)	3.5 mg/dL	Standard Deviation 27
Exubera®	Change From Baseline in Fasting Plasma Lipids	Triglycerides: Week 12 (n=60, 79)	-34.7 mg/dL	Standard Deviation 59.3
Exubera®	Change From Baseline in Fasting Plasma Lipids	Triglycerides: Week 24 (n=51, 59)	-24.3 mg/dL	Standard Deviation 59.3
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	Triglycerides: Week 24 (n=51, 59)	-24.9 mg/dL	Standard Deviation 98.4
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	Total cholesterol: Week 12 (n=60, 79)	1.2 mg/dL	Standard Deviation 34.9
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	LDL cholesterol: Week 12 (n=60, 79)	5.9 mg/dL	Standard Deviation 29.3
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	Total cholesterol: Week 24 (n=51, 59)	0.5 mg/dL	Standard Deviation 29.9
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	Triglycerides: Week 12 (n=60, 79)	-30.7 mg/dL	Standard Deviation 74.3
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	HDL cholesterol: Week 12 (n=60, 79)	1.4 mg/dL	Standard Deviation 5.5
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	LDL cholesterol: Week 24 (n=51, 59)	5.0 mg/dL	Standard Deviation 23.9
Insulin Lispro	Change From Baseline in Fasting Plasma Lipids	HDL cholesterol: Week 24 (n=51, 59)	0.4 mg/dL	Standard Deviation 5.9

Secondary

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit

Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 4 (n=74, 87)	-0.8 percent	Standard Deviation 0.7
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 8 (n=80, 90)	-1.1 percent	Standard Deviation 0.9
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 12 (n=81, 90)	-1.3 percent	Standard Deviation 1.1
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 16 (n=81, 90)	-1.4 percent	Standard Deviation 1.1
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 20 (n=81, 90)	-1.4 percent	Standard Deviation 1.2
Exubera®	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 24 (n=81, 90)	-1.4 percent	Standard Deviation 1.3
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 20 (n=81, 90)	-1.6 percent	Standard Deviation 1.1
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 4 (n=74, 87)	-0.8 percent	Standard Deviation 0.6
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 16 (n=81, 90)	-1.5 percent	Standard Deviation 1.1
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 8 (n=80, 90)	-1.2 percent	Standard Deviation 0.9
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 24 (n=81, 90)	-1.6 percent	Standard Deviation 1
Insulin Lispro	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit	Week 12 (n=81, 90)	-1.5 percent	Standard Deviation 1

Secondary

Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)

Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).

Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: Safety population: all subjects who received at least one dose of study medication; Lispro international units (IU) were converted to milligrams (mg) equivalent; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 1 (n=69, 77)	8.8 IU	Standard Deviation 22.7
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 20 (n=50, 50)	31.2 IU	Standard Deviation 27.4
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 12 (n=57, 68)	24.9 IU	Standard Deviation 26.2
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 24 (n=29, 38)	37.1 IU	Standard Deviation 33.2
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 4 (n=65, 79)	12.8 IU	Standard Deviation 21.2
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 2 (n=60, 69)	14.1 IU	Standard Deviation 24.9
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 8 (n=65, 73)	16.1 IU	Standard Deviation 25.6
Exubera®	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 16 (n=48, 60)	28.1 IU	Standard Deviation 30.7
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 24 (n=29, 38)	31.2 IU	Standard Deviation 28.1
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 1 (n=69, 77)	4.3 IU	Standard Deviation 8.9
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 2 (n=60, 69)	9.1 IU	Standard Deviation 14
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 12 (n=57, 68)	21.3 IU	Standard Deviation 20.7
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 16 (n=48, 60)	24.3 IU	Standard Deviation 21.4
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 20 (n=50, 50)	28.5 IU	Standard Deviation 31.6
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 4 (n=65, 79)	14.0 IU	Standard Deviation 11.7
Insulin Lispro	Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)	Week 8 (n=65, 73)	19.2 IU	Standard Deviation 15.6

Secondary

Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)

Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.

Time frame: Week 4, Week 24

Population: Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.

Secondary

Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)

Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.

Time frame: Baseline, Week 12, Week 24

Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 12 (n=19, 16)	-3.4 mg/dL	Standard Deviation 25.5
Exubera®	Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 24 (n=17, 13)	-3.6 mg/dL	Standard Deviation 22.4
Insulin Lispro	Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 12 (n=19, 16)	2.3 mg/dL	Standard Deviation 20.9
Insulin Lispro	Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)	Week 24 (n=17, 13)	-0.9 mg/dL	Standard Deviation 14.3

Secondary

Change From Baseline Weight at Each Visit

Change = mean body weight at observation minus mean body weight at Baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: FAS; LOCF (all visits except Baseline); N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Exubera®	Change From Baseline Weight at Each Visit	Week 1 Body weight (n=76, 87)	-0.5 kilograms	Standard Deviation 8.4
Exubera®	Change From Baseline Weight at Each Visit	Week 2 Body weight (n=80, 90)	0.5 kilograms	Standard Deviation 1.5
Exubera®	Change From Baseline Weight at Each Visit	Week 4 Body weight (n=81, 90)	0.1 kilograms	Standard Deviation 8.5
Exubera®	Change From Baseline Weight at Each Visit	Week 8 Body weight (n=81, 90)	1.3 kilograms	Standard Deviation 3.4
Exubera®	Change From Baseline Weight at Each Visit	Week 12 Body weight (n=81, 90)	0.6 kilograms	Standard Deviation 9.9
Exubera®	Change From Baseline Weight at Each Visit	Week 20 Body weight (n=81, 90)	2.4 kilograms	Standard Deviation 3.1
Exubera®	Change From Baseline Weight at Each Visit	Week 24 Body weight (n=81, 90)	1.4 kilograms	Standard Deviation 8.4
Exubera®	Change From Baseline Weight at Each Visit	Week 16 Body weight (n=81, 90)	2.5 kilograms	Standard Deviation 3
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 16 Body weight (n=81, 90)	2.8 kilograms	Standard Deviation 3.9
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 1 Body weight (n=76, 87)	-0.3 kilograms	Standard Deviation 5.9
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 12 Body weight (n=81, 90)	2.3 kilograms	Standard Deviation 3.5
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 2 Body weight (n=80, 90)	0.9 kilograms	Standard Deviation 1.7
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 24 Body weight (n=81, 90)	3.8 kilograms	Standard Deviation 4.3
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 4 Body weight (n=81, 90)	0.9 kilograms	Standard Deviation 6.2
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 20 Body weight (n=81, 90)	2.9 kilograms	Standard Deviation 7
Insulin Lispro	Change From Baseline Weight at Each Visit	Week 8 Body weight (n=81, 90)	2.1 kilograms	Standard Deviation 3.1

Secondary

Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24

Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24.

Time frame: Week 4, Week 24

Population: Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.

Secondary

Crude Hypoglycemic Event Rate

Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.

Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Population: Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (NUMBER)
Exubera®	Crude Hypoglycemic Event Rate	Month 1: Overall (n=88, 96)	1.2 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 1: Mild/Moderate (n=88, 96)	1.2 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 2: Overall (n=81, 91)	0.9 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 2: Severe (n=81, 91)	1.3 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 3: Overall (n=74, 87)	1.4 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 3: Mild/Moderate (n=74, 87)	1.4 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 1: Severe (n=88, 96)	0.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 2: Mild/Moderate (n=81, 91)	0.9 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 3: Severe (n=74, 87)	0.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 4: Overall (n=71, 81)	0.8 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 4: Mild/Moderate (n=71, 81)	0.8 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 4: Severe (n=71, 81)	0.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 5: Overall (n=69, 75)	1.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 5: Mild/Moderate (n=69, 75)	1.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 5: Severe (n=69, 75)	0.0 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 6: Overall (n=66, 70)	0.8 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 6: Mild/Moderate (n=66, 70)	0.8 events per subject months
Exubera®	Crude Hypoglycemic Event Rate	Month 6: Severe (n=66, 70)	0.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 5: Mild/Moderate (n=69, 75)	1.2 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 1: Overall (n=88, 96)	1.3 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 4: Overall (n=71, 81)	1.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 1: Severe (n=88, 96)	0.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 6: Severe (n=66, 70)	2.3 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 4: Mild/Moderate (n=71, 81)	1.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 2: Severe (n=81, 91)	0.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 5: Severe (n=69, 75)	0.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 4: Severe (n=71, 81)	0.0 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 1: Mild/Moderate (n=88, 96)	1.3 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 6: Mild/Moderate (n=66, 70)	1.1 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 2: Overall (n=81, 91)	1.4 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 5: Overall (n=69, 75)	1.2 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 2: Mild/Moderate (n=81, 91)	1.4 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 3: Overall (n=74, 87)	1.3 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 3: Mild/Moderate (n=74, 87)	1.3 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 6: Overall (n=66, 70)	1.1 events per subject months
Insulin Lispro	Crude Hypoglycemic Event Rate	Month 3: Severe (n=74, 87)	0.0 events per subject months

Secondary

Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests

Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)\[mg/L\], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.

Time frame: Week 12, Week 24

Population: Due to cancellation of the EXUBERA program, too few patients participated to explore the markers of cardiovascular (CV) risks so these markers were not summarized.

Secondary

Number of Subjects With Hypoglycemic Events

Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.

Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Population: Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (NUMBER)
Exubera®	Number of Subjects With Hypoglycemic Events	Month 1: Mild/Moderate (n=88, 96)	38 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 4: Severe (n=71, 81)	0 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 1: Severe (n=88, 96)	0 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 2: Mild/Moderate (n=81, 91)	25 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 2: Overall (n=81, 91)	26 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 5: Overall (n=69, 75)	25 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 3: Overall (n=74, 87)	29 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 4: Overall (n=71, 81)	22 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 3: Mild/Moderate (n=74, 87)	29 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 5: Mild/Moderate (n=69, 75)	25 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 3: Severe (n=74, 87)	0 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 6: Mild/Moderate (n=66, 70)	17 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 4: Mild/Moderate (n=71, 81)	22 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 5: Severe (n=69, 75)	0 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 6: Severe (n=66, 70)	0 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 6: Overall (n=66, 70)	17 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 1: Overall (n=88, 96)	38 participants
Exubera®	Number of Subjects With Hypoglycemic Events	Month 2: Severe (n=81, 91)	1 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 6: Severe (n=66, 70)	1 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 2: Mild/Moderate (n=81, 91)	29 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 3: Severe (n=74, 87)	0 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 4: Mild/Moderate (n=71, 81)	28 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 4: Severe (n=71, 81)	0 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 5: Overall (n=69, 75)	26 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 6: Mild/Moderate (n=66, 70)	21 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 1: Overall (n=88, 96)	35 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 1: Mild/Moderate (n=88, 96)	35 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 1: Severe (n=88, 96)	0 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 2: Severe (n=81, 91)	0 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 3: Overall (n=74, 87)	38 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 3: Mild/Moderate (n=74, 87)	38 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 4: Overall (n=71, 81)	28 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 5: Mild/Moderate (n=69, 75)	26 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 5: Severe (n=69, 75)	0 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 6: Overall (n=66, 70)	21 participants
Insulin Lispro	Number of Subjects With Hypoglycemic Events	Month 2: Overall (n=81, 91)	29 participants

Secondary

Number of Total Hypoglycemic Events

Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.

Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Arm	Measure	Group	Value (NUMBER)
Exubera®	Number of Total Hypoglycemic Events	Month 2: Overall (n=81, 91)	73 events
Exubera®	Number of Total Hypoglycemic Events	Month 2: Mild/Moderate (n=81, 91)	72 events
Exubera®	Number of Total Hypoglycemic Events	Month 2: Severe (n=81, 91)	1 events
Exubera®	Number of Total Hypoglycemic Events	Month 3: Overall (n=74, 87)	103 events
Exubera®	Number of Total Hypoglycemic Events	Month 3: Mild/Moderate (n=74, 87)	101 events
Exubera®	Number of Total Hypoglycemic Events	Month 3: Severe (n=74, 87)	0 events
Exubera®	Number of Total Hypoglycemic Events	Month 4: Overall (n=71, 81)	57 events
Exubera®	Number of Total Hypoglycemic Events	Month 4: Mild/Moderate (n=71, 81)	57 events
Exubera®	Number of Total Hypoglycemic Events	Month 4: Severe (n=71, 81)	0 events
Exubera®	Number of Total Hypoglycemic Events	Month 6: Mild/Moderate (n=66, 70)	35 events
Exubera®	Number of Total Hypoglycemic Events	Month 6: Severe (n=66, 70)	0 events
Exubera®	Number of Total Hypoglycemic Events	Month 1: Overall (n=88, 96)	106 events
Exubera®	Number of Total Hypoglycemic Events	Month 1: Mild/Moderate (n=88, 96)	106 events
Exubera®	Number of Total Hypoglycemic Events	Month 1: Severe (n=88, 96)	0 events
Exubera®	Number of Total Hypoglycemic Events	Month 5: Overall (n=69, 75)	70 events
Exubera®	Number of Total Hypoglycemic Events	Month 5: Mild/Moderate (n=69, 75)	70 events
Exubera®	Number of Total Hypoglycemic Events	Month 5: Severe (n=69, 75)	0 events
Exubera®	Number of Total Hypoglycemic Events	Month 6: Overall (n=66, 70)	35 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 1: Severe (n=88, 96)	0 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 2: Overall (n=81, 91)	120 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 6: Mild/Moderate (n=66, 70)	47 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 2: Mild/Moderate (n=81, 91)	120 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 6: Overall (n=66, 70)	48 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 2: Severe (n=81, 91)	0 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 6: Severe (n=66, 70)	1 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 3: Overall (n=74, 87)	114 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 5: Overall (n=69, 75)	89 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 3: Mild/Moderate (n=74, 87)	113 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 1: Overall (n=88, 96)	121 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 3: Severe (n=74, 87)	0 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 5: Severe (n=69, 75)	0 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 4: Overall (n=71, 81)	80 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 1: Mild/Moderate (n=88, 96)	121 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 4: Mild/Moderate (n=71, 81)	80 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 5: Mild/Moderate (n=69, 75)	88 events
Insulin Lispro	Number of Total Hypoglycemic Events	Month 4: Severe (n=71, 81)	0 events

Secondary

Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24

Number of subjects acheiving glycemic control: HbA1c target levels of \<7.0%, \<6.5%, and \<6.0% at Week 24.

Time frame: Week 24

Population: FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (NUMBER)
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 6.0% (n=61, 64)	8 participants
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 6.5% (n=61, 64)	24 participants
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 7.0% (n=61, 64)	33 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 6.0% (n=61, 64)	9 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 6.5% (n=61, 64)	27 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24	HbA1c < 7.0% (n=61, 64)	41 participants

Secondary

Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24

Number of subjects that attained HbA1c target levels of \<7%, \< 6.5%,and \<6.0% at Week 24 without an episode of severe hypoglycemia.

Time frame: Week 24

Population: FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.

Arm	Measure	Group	Value (NUMBER)
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c < 6.0% (n=61, 63)	8 participants
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c <6.5% (n=61, 63)	24 participants
Exubera®	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c <7% (n=61, 63)	33 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c < 6.0% (n=61, 63)	8 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c <6.5% (n=61, 63)	26 participants
Insulin Lispro	Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24	HbA1c <7% (n=61, 63)	40 participants

Secondary

Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment

Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated \* days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.

Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Arm	Measure	Group	Value (NUMBER)
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Overall (n=88, 96)	85.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Mild/Moderate (n=88, 96)	85.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Severe (n=88, 96)	85.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Overall (n=81, 91)	78.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Mild/Moderate (n=81, 91)	78.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Severe (n=81, 91)	78.3 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Overall (n=74, 87)	72.2 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Mild/Moderate (n=74, 87)	72.2 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Severe (n=74, 87)	72.2 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Overall (n=71, 81)	70.4 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Mild/Moderate (n=71, 81)	70.4 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Severe (n=71, 81)	70.4 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Overall (n=69, 75)	68.0 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Mild/Moderate (n=69, 75)	68.0 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Severe (n=69, 75)	68.0 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Overall (n=66, 70)	41.4 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Mild/Moderate (n=66, 70)	41.4 subject months of treatment
Exubera®	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Severe (n=66, 70)	41.4 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Mild/Moderate (n=69, 75)	73.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Overall (n=88, 96)	92.9 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Overall (n=71, 81)	77.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Mild/Moderate (n=88, 96)	92.9 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Mild/Moderate (n=66, 70)	43.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 1: Severe (n=88, 96)	92.9 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Mild/Moderate (n=71, 81)	77.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Overall (n=81, 91)	88.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Severe (n=69, 75)	73.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Mild/Moderate (n=81, 91)	88.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 4: Severe (n=71, 81)	77.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 2: Severe (n=81, 91)	88.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Overall (n=66, 70)	43.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Overall (n=74, 87)	85.1 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 5: Overall (n=69, 75)	73.6 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Mild/Moderate (n=74, 87)	85.1 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 6: Severe (n=66, 70)	43.8 subject months of treatment
Insulin Lispro	Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment	Month 3: Severe (n=74, 87)	85.1 subject months of treatment

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment

Baseline Prandial Insulin Dose (at Each Meal) at Each Visit

Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)

Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles

Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests

Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12

Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24

Change From Baseline in Fasting Plasma Lipids

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit

Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)

Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)

Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)

Change From Baseline Weight at Each Visit

Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24

Crude Hypoglycemic Event Rate

Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests

Number of Subjects With Hypoglycemic Events

Number of Total Hypoglycemic Events

Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24

Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24

Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment