Trial Outcomes & Findings for Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes (NCT NCT00348374)
NCT ID: NCT00348374
Last Updated: 2010-03-16
Results Overview
Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
191 participants
Primary outcome timeframe
Baseline, Week 24 (End of Treatment)
Results posted on
2010-03-16
Participant Flow
Participants were recruited from 62 centers between June 2006 and August 2008.
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
103
|
|
Overall Study
Received Study Treatment
|
88
|
96
|
|
Overall Study
COMPLETED
|
69
|
71
|
|
Overall Study
NOT COMPLETED
|
19
|
32
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Other
|
11
|
12
|
|
Overall Study
ongoing at date of cutoff
|
1
|
1
|
|
Overall Study
randomized but did not receive treatment
|
0
|
7
|
Baseline Characteristics
Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
16 participants
n=99 Participants
|
19 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Age, Customized
45-64 years
|
56 participants
n=99 Participants
|
51 participants
n=107 Participants
|
107 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
16 participants
n=99 Participants
|
26 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment
|
-1.4 percent
Standard Deviation 1.3
|
-1.6 percent
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 4 (n=74, 87)
|
-0.8 percent
Standard Deviation 0.7
|
-0.8 percent
Standard Deviation 0.6
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 8 (n=80, 90)
|
-1.1 percent
Standard Deviation 0.9
|
-1.2 percent
Standard Deviation 0.9
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 12 (n=81, 90)
|
-1.3 percent
Standard Deviation 1.1
|
-1.5 percent
Standard Deviation 1.0
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 16 (n=81, 90)
|
-1.4 percent
Standard Deviation 1.1
|
-1.5 percent
Standard Deviation 1.1
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 20 (n=81, 90)
|
-1.4 percent
Standard Deviation 1.2
|
-1.6 percent
Standard Deviation 1.1
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit
Week 24 (n=81, 90)
|
-1.4 percent
Standard Deviation 1.3
|
-1.6 percent
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 24Population: FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
Number of subjects acheiving glycemic control: HbA1c target levels of \<7.0%, \<6.5%, and \<6.0% at Week 24.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
41 participants
|
|
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
|
9 participants
|
|
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
|
27 participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
Number of subjects that attained HbA1c target levels of \<7%, \< 6.5%,and \<6.0% at Week 24 without an episode of severe hypoglycemia.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
8 participants
|
|
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
|
26 participants
|
|
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
|
40 participants
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
5.5 mg/dL
Standard Deviation 58.4
|
|
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
|
-40.8 mg/dL
Standard Deviation 99.3
|
|
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
|
9.3 mg/dL
Standard Deviation 54.3
|
|
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
|
-19.3 mg/dL
Standard Deviation 77.5
|
|
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
|
-27.9 mg/dL
Standard Deviation 84.2
|
|
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
|
-32.5 mg/dL
Standard Deviation 89.5
|
|
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
|
-52.0 mg/dL
Standard Deviation 92.0
|
|
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 80.0
|
-54.3 mg/dL
Standard Deviation 84.9
|
|
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
|
-4.3 mg/dL
Standard Deviation 61.9
|
|
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 85.0
|
-48.5 mg/dL
Standard Deviation 87.0
|
|
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
|
-52.4 mg/dL
Standard Deviation 96.0
|
|
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
|
-71.5 mg/dL
Standard Deviation 99.0
|
|
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 67.0
|
-20.8 mg/dL
Standard Deviation 48.6
|
|
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
|
-59.0 mg/dL
Standard Deviation 78.8
|
|
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
|
-61.0 mg/dL
Standard Deviation 95.7
|
|
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
|
-86.5 mg/dL
Standard Deviation 98.5
|
|
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
|
-22.2 mg/dL
Standard Deviation 63.0
|
|
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
|
-74.8 mg/dL
Standard Deviation 84.3
|
|
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
|
-60.6 mg/dL
Standard Deviation 98.9
|
|
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
|
-81.6 mg/dL
Standard Deviation 81.5
|
|
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
|
-16.9 mg/dL
Standard Deviation 62.0
|
|
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
|
-60.5 mg/dL
Standard Deviation 81.7
|
|
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
|
-69.9 mg/dL
Standard Deviation 99.2
|
|
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
|
-90.6 mg/dL
Standard Deviation 96.1
|
|
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
|
-26.3 mg/dL
Standard Deviation 59.9
|
|
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
|
-78.5 mg/dL
Standard Deviation 70.7
|
|
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
|
-74.1 mg/dL
Standard Deviation 91.5
|
|
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
|
-78.7 mg/dL
Standard Deviation 83.9
|
|
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
|
-27.6 mg/dL
Standard Deviation 43.9
|
|
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
|
-75.1 mg/dL
Standard Deviation 66.3
|
|
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
|
-65.5 mg/dL
Standard Deviation 94.0
|
|
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
|
-78.0 mg/dL
Standard Deviation 82.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
-30.5 mg/dL
Standard Deviation 58.2
|
|
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
|
-44.4 mg/dL
Standard Deviation 33.3
|
|
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
|
-50.3 mg/dL
Standard Deviation 73.2
|
|
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
|
-69.5 mg/dL
Standard Deviation 65.7
|
|
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
|
-77.4 mg/dL
Standard Deviation 68.3
|
|
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
|
-76.4 mg/dL
Standard Deviation 68.8
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
-73.6 mg/dL
Standard Deviation 54.0
|
|
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 95.0
|
-75.7 mg/dL
Standard Deviation 59.7
|
|
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
|
-74.2 mg/dL
Standard Deviation 66.2
|
|
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
|
-34.8 mg/dL
Standard Deviation 64.3
|
|
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 0.0
|
-86.0 mg/dL
Standard Deviation 43.5
|
|
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
|
-59.8 mg/dL
Standard Deviation 61.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
-6.7 mg/dL
Standard Deviation 31.2
|
|
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
|
0.5 mg/dL
Standard Deviation 29.9
|
|
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
|
-4.7 mg/dL
Standard Deviation 29.5
|
|
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
|
1.2 mg/dL
Standard Deviation 34.9
|
|
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
|
1.4 mg/dL
Standard Deviation 5.5
|
|
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
|
1.1 mg/dL
Standard Deviation 5.3
|
|
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
|
0.4 mg/dL
Standard Deviation 5.9
|
|
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
|
-0.4 mg/dL
Standard Deviation 6.0
|
|
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
|
5.9 mg/dL
Standard Deviation 29.3
|
|
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
|
-1.5 mg/dL
Standard Deviation 26.8
|
|
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 27.0
|
5.0 mg/dL
Standard Deviation 23.9
|
|
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
|
-0.7 mg/dL
Standard Deviation 19.9
|
|
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
|
-30.7 mg/dL
Standard Deviation 74.3
|
|
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
|
-31.6 mg/dL
Standard Deviation 71.4
|
|
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
|
-24.9 mg/dL
Standard Deviation 98.4
|
|
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
|
-17.9 mg/dL
Standard Deviation 89.0
|
SECONDARY outcome
Timeframe: Week 12, Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: 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.
Change = mean body weight at observation minus mean body weight at Baseline.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
Change From Baseline Weight at Each Visit
Week 1 Body weight (n=76, 87)
|
-0.5 kilograms
Standard Deviation 8.4
|
-0.3 kilograms
Standard Deviation 5.9
|
|
Change From Baseline Weight at Each Visit
Week 2 Body weight (n=80, 90)
|
0.5 kilograms
Standard Deviation 1.5
|
0.9 kilograms
Standard Deviation 1.7
|
|
Change From Baseline Weight at Each Visit
Week 4 Body weight (n=81, 90)
|
0.1 kilograms
Standard Deviation 8.5
|
0.9 kilograms
Standard Deviation 6.2
|
|
Change From Baseline Weight at Each Visit
Week 8 Body weight (n=81, 90)
|
1.3 kilograms
Standard Deviation 3.4
|
2.1 kilograms
Standard Deviation 3.1
|
|
Change From Baseline Weight at Each Visit
Week 12 Body weight (n=81, 90)
|
0.6 kilograms
Standard Deviation 9.9
|
2.3 kilograms
Standard Deviation 3.5
|
|
Change From Baseline Weight at Each Visit
Week 16 Body weight (n=81, 90)
|
2.5 kilograms
Standard Deviation 3.0
|
2.8 kilograms
Standard Deviation 3.9
|
|
Change From Baseline Weight at Each Visit
Week 20 Body weight (n=81, 90)
|
2.4 kilograms
Standard Deviation 3.1
|
2.9 kilograms
Standard Deviation 7.0
|
|
Change From Baseline Weight at Each Visit
Week 24 Body weight (n=81, 90)
|
1.4 kilograms
Standard Deviation 8.4
|
3.8 kilograms
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Lipids
Total cholesterol: Week 12 (n=60, 79)
|
-4.4 mg/dL
Standard Deviation 21.1
|
1.2 mg/dL
Standard Deviation 34.9
|
|
Change From Baseline in Fasting Plasma Lipids
Total cholesterol: Week 24 (n=51, 59)
|
-0.2 mg/dL
Standard Deviation 31.7
|
0.5 mg/dL
Standard Deviation 29.9
|
|
Change From Baseline in Fasting Plasma Lipids
HDL cholesterol: Week 12 (n=60, 79)
|
1.2 mg/dL
Standard Deviation 4.5
|
1.4 mg/dL
Standard Deviation 5.5
|
|
Change From Baseline in Fasting Plasma Lipids
HDL cholesterol: Week 24 (n=51, 59)
|
1.1 mg/dL
Standard Deviation 5.2
|
0.4 mg/dL
Standard Deviation 5.9
|
|
Change From Baseline in Fasting Plasma Lipids
LDL cholesterol: Week 12 (n=60, 79)
|
1.3 mg/dL
Standard Deviation 19.8
|
5.9 mg/dL
Standard Deviation 29.3
|
|
Change From Baseline in Fasting Plasma Lipids
LDL cholesterol: Week 24 (n=51, 59)
|
3.5 mg/dL
Standard Deviation 27.0
|
5.0 mg/dL
Standard Deviation 23.9
|
|
Change From Baseline in Fasting Plasma Lipids
Triglycerides: Week 12 (n=60, 79)
|
-34.7 mg/dL
Standard Deviation 59.3
|
-30.7 mg/dL
Standard Deviation 74.3
|
|
Change From Baseline in Fasting Plasma Lipids
Triglycerides: Week 24 (n=51, 59)
|
-24.3 mg/dL
Standard Deviation 59.3
|
-24.9 mg/dL
Standard Deviation 98.4
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: 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.
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).
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
|---|---|---|
|
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
|
4.3 IU
Standard Deviation 8.9
|
|
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
|
9.1 IU
Standard Deviation 14.0
|
|
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
|
14.0 IU
Standard Deviation 11.7
|
|
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
|
19.2 IU
Standard Deviation 15.6
|
|
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
|
21.3 IU
Standard Deviation 20.7
|
|
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
|
24.3 IU
Standard Deviation 21.4
|
|
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
|
28.5 IU
Standard Deviation 31.6
|
|
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
|
31.2 IU
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: 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.
Dose of inhaled insulin prior to each meal at each visit.
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
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).
|
|---|---|---|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 0: Pre-breakfast (n=81)
|
4.14 mg
Standard Deviation 1.39
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 0: Pre-lunch (n=86)
|
4.10 mg
Standard Deviation 1.37
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 0: Pre-dinner (n=87)
|
4.06 mg
Standard Deviation 1.33
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 1: Pre-breakfast (n=87)
|
4.25 mg
Standard Deviation 1.45
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 1: Pre-lunch (n=87)
|
4.33 mg
Standard Deviation 1.42
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 1: Pre-dinner (n=87)
|
4.35 mg
Standard Deviation 1.49
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 2: Pre-breakfast (n=87)
|
4.89 mg
Standard Deviation 1.63
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 2: Pre-lunch (n=87)
|
4.94 mg
Standard Deviation 1.72
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 2: Pre-dinner (n=87)
|
5.09 mg
Standard Deviation 1.82
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 4: Pre-breakfast (n=84)
|
5.44 mg
Standard Deviation 2.16
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 4: Pre-lunch (n=84)
|
5.46 mg
Standard Deviation 2.32
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 4: Pre-dinner (n=84)
|
5.71 mg
Standard Deviation 2.36
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 8: Pre-breakfast (n=80)
|
6.09 mg
Standard Deviation 2.93
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 8: Pre-lunch (n=80)
|
6.11 mg
Standard Deviation 2.99
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 8: Pre-dinner (n=80)
|
6.41 mg
Standard Deviation 3.07
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 12: Pre-breakfast (n=74)
|
6.40 mg
Standard Deviation 3.17
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 12: Pre-lunch (n=74)
|
6.51 mg
Standard Deviation 3.35
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 12: Pre-dinner (n=74)
|
7.01 mg
Standard Deviation 3.67
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 16: Pre-breakfast (n=71)
|
6.69 mg
Standard Deviation 3.60
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 16: Pre-lunch (n=71)
|
6.78 mg
Standard Deviation 3.82
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 16: Pre-dinner (n=71)
|
7.40 mg
Standard Deviation 4.04
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 20: Pre-breakfast (n=68)
|
7.01 mg
Standard Deviation 4.06
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 20: Pre-lunch (n=68)
|
7.10 mg
Standard Deviation 4.20
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 20: Pre-dinner (n=68)
|
7.58 mg
Standard Deviation 4.30
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 24: Pre-breakfast (n=66)
|
7.53 mg
Standard Deviation 4.78
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 24: Pre-lunch (n=66)
|
7.70 mg
Standard Deviation 4.69
|
—
|
|
Baseline Prandial Insulin Dose (at Each Meal) at Each Visit
Week 24: Pre-dinner (n=66)
|
7.83 mg
Standard Deviation 4.81
|
—
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6Population: 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.
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.
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
|---|---|---|
|
Number of Subjects With Hypoglycemic Events
Month 3: Overall (n=74, 87)
|
29 participants
|
38 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 3: Mild/Moderate (n=74, 87)
|
29 participants
|
38 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 1: Overall (n=88, 96)
|
38 participants
|
35 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 1: Mild/Moderate (n=88, 96)
|
38 participants
|
35 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 1: Severe (n=88, 96)
|
0 participants
|
0 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 2: Overall (n=81, 91)
|
26 participants
|
29 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 2: Mild/Moderate (n=81, 91)
|
25 participants
|
29 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 2: Severe (n=81, 91)
|
1 participants
|
0 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 3: Severe (n=74, 87)
|
0 participants
|
0 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 4: Overall (n=71, 81)
|
22 participants
|
28 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 4: Mild/Moderate (n=71, 81)
|
22 participants
|
28 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 4: Severe (n=71, 81)
|
0 participants
|
0 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 5: Overall (n=69, 75)
|
25 participants
|
26 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 5: Mild/Moderate (n=69, 75)
|
25 participants
|
26 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 5: Severe (n=69, 75)
|
0 participants
|
0 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 6: Overall (n=66, 70)
|
17 participants
|
21 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 6: Mild/Moderate (n=66, 70)
|
17 participants
|
21 participants
|
|
Number of Subjects With Hypoglycemic Events
Month 6: Severe (n=66, 70)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6Population: 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.
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.
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
|---|---|---|
|
Number of Total Hypoglycemic Events
Month 6: Overall (n=66, 70)
|
35 events
|
48 events
|
|
Number of Total Hypoglycemic Events
Month 1: Overall (n=88, 96)
|
106 events
|
121 events
|
|
Number of Total Hypoglycemic Events
Month 1: Mild/Moderate (n=88, 96)
|
106 events
|
121 events
|
|
Number of Total Hypoglycemic Events
Month 1: Severe (n=88, 96)
|
0 events
|
0 events
|
|
Number of Total Hypoglycemic Events
Month 2: Overall (n=81, 91)
|
73 events
|
120 events
|
|
Number of Total Hypoglycemic Events
Month 2: Mild/Moderate (n=81, 91)
|
72 events
|
120 events
|
|
Number of Total Hypoglycemic Events
Month 2: Severe (n=81, 91)
|
1 events
|
0 events
|
|
Number of Total Hypoglycemic Events
Month 3: Overall (n=74, 87)
|
103 events
|
114 events
|
|
Number of Total Hypoglycemic Events
Month 3: Mild/Moderate (n=74, 87)
|
101 events
|
113 events
|
|
Number of Total Hypoglycemic Events
Month 3: Severe (n=74, 87)
|
0 events
|
0 events
|
|
Number of Total Hypoglycemic Events
Month 4: Overall (n=71, 81)
|
57 events
|
80 events
|
|
Number of Total Hypoglycemic Events
Month 4: Mild/Moderate (n=71, 81)
|
57 events
|
80 events
|
|
Number of Total Hypoglycemic Events
Month 4: Severe (n=71, 81)
|
0 events
|
0 events
|
|
Number of Total Hypoglycemic Events
Month 5: Overall (n=69, 75)
|
70 events
|
89 events
|
|
Number of Total Hypoglycemic Events
Month 5: Mild/Moderate (n=69, 75)
|
70 events
|
88 events
|
|
Number of Total Hypoglycemic Events
Month 5: Severe (n=69, 75)
|
0 events
|
0 events
|
|
Number of Total Hypoglycemic Events
Month 6: Mild/Moderate (n=66, 70)
|
35 events
|
47 events
|
|
Number of Total Hypoglycemic Events
Month 6: Severe (n=66, 70)
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6Population: 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.
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.
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
|---|---|---|
|
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
|
43.8 subject months of treatment
|
|
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
|
92.9 subject months of treatment
|
|
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
|
92.9 subject months of treatment
|
|
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
|
92.9 subject months of treatment
|
|
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
|
88.8 subject months of treatment
|
|
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
|
88.8 subject months of treatment
|
|
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
|
88.8 subject months of treatment
|
|
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
|
85.1 subject months of treatment
|
|
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
|
85.1 subject months of treatment
|
|
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
|
85.1 subject months of treatment
|
|
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
|
77.6 subject months of treatment
|
|
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
|
77.6 subject months of treatment
|
|
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
|
77.6 subject months of treatment
|
|
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
|
73.6 subject months of treatment
|
|
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
|
73.6 subject months of treatment
|
|
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
|
73.6 subject months of treatment
|
|
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
|
43.8 subject months of treatment
|
|
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
|
43.8 subject months of treatment
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6Population: Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
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.
Outcome measures
| Measure |
Exubera®
n=88 Participants
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.
|
Insulin Lispro
n=96 Participants
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).
|
|---|---|---|
|
Crude Hypoglycemic Event Rate
Month 1: Overall (n=88, 96)
|
1.2 events per subject months
|
1.3 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 1: Mild/Moderate (n=88, 96)
|
1.2 events per subject months
|
1.3 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 1: Severe (n=88, 96)
|
0.0 events per subject months
|
0.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 2: Overall (n=81, 91)
|
0.9 events per subject months
|
1.4 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 2: Mild/Moderate (n=81, 91)
|
0.9 events per subject months
|
1.4 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 2: Severe (n=81, 91)
|
1.3 events per subject months
|
0.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 3: Overall (n=74, 87)
|
1.4 events per subject months
|
1.3 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 3: Mild/Moderate (n=74, 87)
|
1.4 events per subject months
|
1.3 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 3: Severe (n=74, 87)
|
0.0 events per subject months
|
0.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 4: Overall (n=71, 81)
|
0.8 events per subject months
|
1.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 4: Mild/Moderate (n=71, 81)
|
0.8 events per subject months
|
1.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 4: Severe (n=71, 81)
|
0.0 events per subject months
|
0.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 5: Overall (n=69, 75)
|
1.0 events per subject months
|
1.2 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 5: Mild/Moderate (n=69, 75)
|
1.0 events per subject months
|
1.2 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 5: Severe (n=69, 75)
|
0.0 events per subject months
|
0.0 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 6: Overall (n=66, 70)
|
0.8 events per subject months
|
1.1 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 6: Mild/Moderate (n=66, 70)
|
0.8 events per subject months
|
1.1 events per subject months
|
|
Crude Hypoglycemic Event Rate
Month 6: Severe (n=66, 70)
|
0.0 events per subject months
|
2.3 events per subject months
|
SECONDARY outcome
Timeframe: Week 4, Week 24Population: Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, Week 24Population: Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
-33.0 mg/dL
Standard Deviation 41.9
|
|
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
|
-23.4 mg/dL
Standard Deviation 43.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.
Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.
Outcome measures
| Measure |
Exubera®
n=81 Participants
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.
|
Insulin Lispro
n=90 Participants
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).
|
|---|---|---|
|
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
|
2.3 mg/dL
Standard Deviation 20.9
|
|
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
|
-0.9 mg/dL
Standard Deviation 14.3
|
Adverse Events
Exubera®
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Insulin Lispro
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exubera®
n=88 participants at risk
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.
|
Insulin Lispro
n=96 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
1.0%
1/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
1.0%
1/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.1%
1/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
0.00%
0/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.1%
1/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
0.00%
0/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
1.0%
1/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
1.1%
1/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
0.00%
0/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
0.00%
0/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
Other adverse events
| Measure |
Exubera®
n=88 participants at risk
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.
|
Insulin Lispro
n=96 participants at risk
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).
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
3.4%
3/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
5.2%
5/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
4.5%
4/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
5.2%
5/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
6.2%
6/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
General disorders
Hunger
|
1.1%
1/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
5.2%
5/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
5.7%
5/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
4.2%
4/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
5/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
3.1%
3/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.7%
5/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
3.1%
3/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
9/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
9.4%
9/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
65.9%
58/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
61.5%
59/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.2%
9/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
15.6%
15/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
9.1%
8/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
7.3%
7/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
11.4%
10/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
12.5%
12/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
8/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
1.0%
1/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.2%
9/88
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
12.5%
12/96
Number of participants at risk for serious and other adverse events was determined by the number of participants who took at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER