Trial Outcomes & Findings for Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake (NCT NCT00747006)
NCT ID: NCT00747006
Last Updated: 2014-10-30
Results Overview
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
TERMINATED
PHASE2
18 participants
0 to 240 minutes
2014-10-30
Participant Flow
Participant milestones
| Measure |
Original Protocol Type 1 Diabetes
Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Original Protocol Type 2 Diabetes
Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Amendment 1 Type 2 Diabetes
Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
3
|
|
Overall Study
COMPLETED
|
4
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Original Protocol Type 1 Diabetes
Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Original Protocol Type 2 Diabetes
Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Amendment 1 Type 2 Diabetes
Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
Baseline characteristics by cohort
| Measure |
Original Protocol Type 1 Diabetes
n=7 Participants
Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Original Protocol Type 2 Diabetes
n=8 Participants
Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Amendment 1 Type 2 Diabetes
n=3 Participants
Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.7 years
n=5 Participants
|
59.4 years
n=7 Participants
|
50.7 years
n=5 Participants
|
50.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=3 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
|
-41.44 min*mg/dL
Interval -43.44 to -39.43
|
—
|
—
|
251.65 min*mg/dL
Interval 24.08 to 490.63
|
454.07 min*mg/dL
Interval 329.64 to 636.5
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
n=3 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=2 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
|
104.32 min*mg/dL
Interval 14.5 to 194.13
|
—
|
10.80 min*mg/dL
Interval -44.86 to 98.5
|
199.35 min*mg/dL
Interval 116.7 to 282.0
|
440.90 min*mg/dL
Interval 269.18 to 583.13
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=1 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
|
-6.11 min*mg/dL
Interval -22.63 to 10.41
|
-74.26 min*mg/dL
Interval -99.88 to -48.63
|
-22.80 min*mg/dL
Interval -22.8 to -22.8
|
—
|
11.56 min*mg/dL
Interval -2.36 to 25.47
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=2 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
|
15.77 min*mg/dL
Interval 9.48 to 22.06
|
-51.26 min*mg/dL
Interval -89.13 to -13.38
|
4.18 min*mg/dL
Interval -15.39 to 23.75
|
—
|
-8.15 min*mg/dL
Interval -68.76 to 52.47
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=3 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
|
54.00 mg/dL
Interval 42.0 to 66.0
|
—
|
—
|
129.67 mg/dL
Interval 75.0 to 210.0
|
201.00 mg/dL
Interval 163.0 to 231.0
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
n=3 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=2 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
|
53.50 mg/dL
Interval 43.0 to 64.0
|
—
|
44.33 mg/dL
Interval 42.0 to 48.0
|
89.50 mg/dL
Interval 78.0 to 101.0
|
186.33 mg/dL
Interval 134.0 to 234.0
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=1 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
|
29.50 mg/dL
Interval 26.0 to 33.0
|
14.50 mg/dL
Interval 13.0 to 16.0
|
16.00 mg/dL
Interval 16.0 to 16.0
|
—
|
18.50 mg/dL
Interval 17.0 to 20.0
|
PRIMARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=2 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
|
44.50 mg/dL
Interval 44.0 to 45.0
|
20.00 mg/dL
Interval 9.0 to 31.0
|
23.50 mg/dL
Interval 11.0 to 36.0
|
—
|
45.50 mg/dL
Interval 35.0 to 56.0
|
SECONDARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI
Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=3 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
|
53.89 min*mg/dL
Interval 47.61 to 60.16
|
—
|
—
|
19.16 min*mg/dL
Interval 0.0 to 57.49
|
8.77 min*mg/dL
Interval 0.0 to 26.05
|
SECONDARY outcome
Timeframe: 0 to 240 minutesPopulation: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI
Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
Fasting state
|
50% Carbohydrate Load
n=3 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
n=2 Participants
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=3 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
|
10.25 min*mg/dL
Interval 0.0 to 20.5
|
—
|
30.45 min*mg/dL
Interval 0.0 to 59.0
|
6.30 min*mg/dL
Interval 0.0 to 12.6
|
3.18 min*mg/dL
Interval 0.0 to 9.55
|
SECONDARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=1 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
|
18.00 min*mg/dL
Interval 5.36 to 30.63
|
74.26 min*mg/dL
Interval 48.63 to 99.88
|
24.04 min*mg/dL
Interval 24.04 to 24.04
|
—
|
5.65 min*mg/dL
Interval 1.53 to 9.77
|
SECONDARY outcome
Timeframe: 0 to 240 minutesPopulation: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Outcome measures
| Measure |
100% Carbohydrate Load
n=2 Participants
Standard meal to which subjects titrated their insulin dose.
|
0% Carbohydrate Load
n=2 Participants
Fasting state
|
50% Carbohydrate Load
n=2 Participants
Meal consisting of half of the carbohydrates from the standard meal
|
150% Carbohydrate Load
Meal consisting of 1.5 times the carbohydrate load of the standard meal.
|
200% Carbohydrate Load
n=2 Participants
Meal consisting of 2 times the carbohydrate load of the standard meal.
|
|---|---|---|---|---|---|
|
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
|
14.60 min*mg/dL
Interval 11.34 to 17.86
|
51.63 min*mg/dL
Interval 14.13 to 89.13
|
12.52 min*mg/dL
Interval 7.5 to 17.53
|
—
|
40.84 min*mg/dL
Interval 10.89 to 70.79
|
Adverse Events
TI Original Protocol Type 1 DM
TI Original Protocol Type 2 DM
TI Amendment 1 Type 2 DM
Humalog Amendment 1 Type 2 DM
Serious adverse events
| Measure |
TI Original Protocol Type 1 DM
n=7 participants at risk
Original protocol type 1 diabetes mellitus subjects
|
TI Original Protocol Type 2 DM
n=8 participants at risk
Original protocol type 2 diabetes mellitus subjects
|
TI Amendment 1 Type 2 DM
n=3 participants at risk
Technosphere Insulin treated subjects in protocol amendment 1
|
Humalog Amendment 1 Type 2 DM
n=2 participants at risk
Humalog treated subjects in protocol amendment 1
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Renal and urinary disorders
Renal papillary necrosis
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
Other adverse events
| Measure |
TI Original Protocol Type 1 DM
n=7 participants at risk
Original protocol type 1 diabetes mellitus subjects
|
TI Original Protocol Type 2 DM
n=8 participants at risk
Original protocol type 2 diabetes mellitus subjects
|
TI Amendment 1 Type 2 DM
n=3 participants at risk
Technosphere Insulin treated subjects in protocol amendment 1
|
Humalog Amendment 1 Type 2 DM
n=2 participants at risk
Humalog treated subjects in protocol amendment 1
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/2
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/2
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/3
|
50.0%
1/2
|
|
Investigations
Platelet count increased
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/3
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
100.0%
7/7
|
75.0%
6/8
|
66.7%
2/3
|
50.0%
1/2
|
|
Nervous system disorders
Headache
|
14.3%
1/7
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7
|
0.00%
0/8
|
33.3%
1/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/7
|
12.5%
1/8
|
33.3%
1/3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
General disorders
Venipuncture site thrombosis
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Immune system disorders
Allergy to plants
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Influenza
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Tooth abscess
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
14.3%
1/7
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/2
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/7
|
12.5%
1/8
|
0.00%
0/3
|
0.00%
0/2
|
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