Trial Outcomes & Findings for A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes (NCT NCT00570687)
NCT ID: NCT00570687
Last Updated: 2014-10-16
Results Overview
Time to minimum EGP post dose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
0-480 minutes
Results posted on
2014-10-16
Participant Flow
This single-center study was conducted at: Profil Institut fur Stoffwechselforschung GmbH Hellersbergstrasse 9 D-41460 Neuss, Germany Principal Investigator: Dr. Klaus Rave First subjects first visit: 20 September 2007 Last subject last visit: 30 January 2009
This randomized, open-label crossover study was conducted in 2 phases: original protocol (TI 45 U, Exubera 4mg and Lispro 12 U) and amendment 1 (TI 60U or TI 90 U, and Lispro 10 U). Both original protocol and amendment 1 had screening visits, meal challenge and glucose clamp visits (with a blood-loss recovery period between them) and final visits.
Participant milestones
| Measure |
Amendment 1: TI 60 U Then Insulin Lispro 10 U
60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
|
Amendment 1: 10 U Insulin Lispro Then 60 U TI
10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Amendment 1: TI 90 U Then 10 U Insulin Lispro
90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
|
Amendment 1: 10 U Insulin Lispro Then 90 U TI
10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Original Protocol: TI to Insulin Lispro to Exubera
45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
|
Original Protocol: TI to Exubera to Insulin Lispro
45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
|
Original Protocol: Exubera to Insulin Lispro to TI
4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Original Protocol: Exubera to TI to Insulin Lispro
4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
|
Original Protocol: Insulin Lispro to TI to Exubera
12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
|
Original Protocol: Insulin Lispro to Exubera to TI
12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Meal Challenge 1 (1 Day) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 1 (1 Day) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 1 (1 Day) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (7-21 Days) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 1 (7-21 Days) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 1 (7-21 Days) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 2 (1 Day) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 2 (1 Day) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 2 (1 Day) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (7-21 Days) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 2 (7-21 Days) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 2 (7-21 Days) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 3 (1 Day) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 3 (1 Day) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Meal Challenge 3 (1 Day) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 3 (7-21 Days) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout 3 (7-21 Days) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Washout 3 (7-21 Days) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
2
|
3
|
2
|
3
|
|
Clamp 1 (1 Day) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Clamp 1 (1 Day) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Clamp 1 (1 Day) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 4 (7-21 Days) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Washout 4 (7-21 Days) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout 4 (7-21 Days) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Clamp 2 (1 Day) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Clamp 2 (1 Day) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Clamp 2 (1 Day) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 5 (7-21 Days) - Orig Protocol
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout 5 (7-21 Days) - Orig Protocol
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 5 (7-21 Days) - Orig Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Meal Challenge 1 (1 Day) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 1 (1 Day) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 1 (1 Day) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (7-21 Days) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (7-21 Days) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (7-21 Days) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 2 (1 Day) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 2 (1 Day) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Meal Challenge 2 (1 Day) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (8 Weeks) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (8 Weeks) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (8 Weeks) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 1 (1 Day) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 1 (1 Day) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 1 (1 Day) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 3 (7-21 Days) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 3 (7-21 Days) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 3 (7-21 Days) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 2 (1 Day) - Amendment 1
STARTED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 2 (1 Day) - Amendment 1
COMPLETED
|
4
|
2
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Clamp 2 (1 Day) - Amendment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Amendment 1: TI 60 U Then Insulin Lispro 10 U
60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
|
Amendment 1: 10 U Insulin Lispro Then 60 U TI
10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Amendment 1: TI 90 U Then 10 U Insulin Lispro
90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
|
Amendment 1: 10 U Insulin Lispro Then 90 U TI
10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Original Protocol: TI to Insulin Lispro to Exubera
45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
|
Original Protocol: TI to Exubera to Insulin Lispro
45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
|
Original Protocol: Exubera to Insulin Lispro to TI
4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
Original Protocol: Exubera to TI to Insulin Lispro
4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
|
Original Protocol: Insulin Lispro to TI to Exubera
12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
|
Original Protocol: Insulin Lispro to Exubera to TI
12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Washout 3 (7-21 Days) - Orig Protocol
Sponsor Decision
|
0
|
0
|
0
|
0
|
3
|
3
|
2
|
3
|
2
|
3
|
|
Washout 4 (7-21 Days) - Orig Protocol
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout 5 (7-21 Days) - Orig Protocol
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Amendment 1
n=12 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Original Protocol
n=18 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-480 minutesPopulation: Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.
Time to minimum EGP post dose
Outcome measures
| Measure |
Amendment 1 - TI Inhalation Powder 90 U
n=3 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - TI Inhalation Powder 60U
n=6 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - Insulin Lispro 10 U
n=12 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Original Protocol - TI Inhalation Powder 45 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Exubera 4 mg
n=17 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Insulin Lispro 12 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
|---|---|---|---|---|---|---|
|
Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
|
75.0 Minutes
Interval 20.0 to 80.0
|
75.0 Minutes
Interval 45.0 to 310.0
|
125.0 Minutes
Interval 80.0 to 210.0
|
60 Minutes
Interval 30.0 to 460.0
|
160 Minutes
Interval 80.0 to 480.0
|
130 Minutes
Interval 50.0 to 350.0
|
PRIMARY outcome
Timeframe: 0-480 minutesPopulation: Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.
Minimum calculated EGP per subject as change from baseline
Outcome measures
| Measure |
Amendment 1 - TI Inhalation Powder 90 U
n=3 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - TI Inhalation Powder 60U
n=6 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - Insulin Lispro 10 U
n=12 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Original Protocol - TI Inhalation Powder 45 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Exubera 4 mg
n=17 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Insulin Lispro 12 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
|---|---|---|---|---|---|---|
|
Minimum EGP - Meal Challenge
|
-10.29 µmol/kg/min
Standard Deviation 4.394
|
-6.92 µmol/kg/min
Standard Deviation 1.584
|
-7.11 µmol/kg/min
Standard Deviation 2.018
|
-7.59 µmol/kg/min
Standard Deviation 3.015
|
-7.86 µmol/kg/min
Standard Deviation 2.962
|
-7.63 µmol/kg/min
Standard Deviation 2.709
|
PRIMARY outcome
Timeframe: 0-480 minutesPopulation: Amendment 1: Subjects with type 2 diabetes. All subjects crossed over to lispro treatment. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; AOC could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.
EGP area over the curve from 0 to 480 minutes postdose
Outcome measures
| Measure |
Amendment 1 - TI Inhalation Powder 90 U
n=6 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - TI Inhalation Powder 60U
n=6 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - Insulin Lispro 10 U
n=12 Participants
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Original Protocol - TI Inhalation Powder 45 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Exubera 4 mg
n=17 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Insulin Lispro 12 U
n=16 Participants
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
|---|---|---|---|---|---|---|
|
EGP AOC0-480 - Meal Challenge
|
2272.8 µmol/kg
Standard Deviation 266.2
|
2108.7 µmol/kg
Standard Deviation 498.3
|
2190.9 µmol/kg
Standard Deviation 674.5
|
2129.4 µmol/kg
Standard Deviation 764.4
|
2488.3 µmol/kg
Standard Deviation 845.1
|
1985.9 µmol/kg
Standard Deviation 623.5
|
Adverse Events
Amendment 1 -TI Inhalation Powder 90 U
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Amendment 1 - TI Inhalation Powder 60 U
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Amendment 1 - Insulin Lispro 10 U
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Original Protocol - TI Inhalation Powder 45 U
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Original Protocol - Exubera 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Original Protocol - Insulin Lispro 12 U
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amendment 1 -TI Inhalation Powder 90 U
n=6 participants at risk
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - TI Inhalation Powder 60 U
n=6 participants at risk
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Amendment 1 - Insulin Lispro 10 U
n=12 participants at risk
2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
|
Original Protocol - TI Inhalation Powder 45 U
n=18 participants at risk
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Exubera 4 mg
n=18 participants at risk
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
Original Protocol - Insulin Lispro 12 U
n=18 participants at risk
3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
83.3%
5/6 • Number of events 10 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
66.7%
4/6 • Number of events 4 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
11.1%
2/18 • Number of events 3 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
22.2%
4/18 • Number of events 4 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
8.3%
1/12 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
16.7%
1/6 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Musculoskeletal and connective tissue disorders
Hand fracture
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/6 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/12 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
0.00%
0/18 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
5.6%
1/18 • Number of events 1 • From the time the informed consent was signed to 30 days after the last study visit or study-related procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.
- Publication restrictions are in place
Restriction type: OTHER