Trial Outcomes & Findings for Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus (NCT NCT01451398)
NCT ID: NCT01451398
Last Updated: 2014-10-17
Results Overview
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-10-17
Participant Flow
First Patient enrolled November 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil
6 week Screening Period prior to OAD run-in period. 1379 Screened /539 Eligible of which 535 entered the run-in period. 439 met randomization criteria at end of run-in of which 353 were randomized.
Participant milestones
| Measure |
TI Inhalation Powder + OADs
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
176
|
|
Overall Study
COMPLETED
|
150
|
139
|
|
Overall Study
NOT COMPLETED
|
27
|
37
|
Reasons for withdrawal
| Measure |
TI Inhalation Powder + OADs
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
14
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Non-compliance with study drug
|
1
|
3
|
|
Overall Study
Non-compliance with protocol
|
1
|
1
|
|
Overall Study
Moved out of country
|
0
|
1
|
|
Overall Study
Adverse Event + Elevated Fasting Glucose
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-30 years
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Age, Customized
31-49 years
|
37 participants
n=39 Participants
|
33 participants
n=41 Participants
|
70 participants
n=35 Participants
|
|
Age, Customized
50-64 years
|
102 participants
n=39 Participants
|
110 participants
n=41 Participants
|
212 participants
n=35 Participants
|
|
Age, Customized
>=65 years
|
37 participants
n=39 Participants
|
33 participants
n=41 Participants
|
70 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
197 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
156 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=39 Participants
|
155 Participants
n=41 Participants
|
306 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=39 Participants
|
135 Participants
n=41 Participants
|
269 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=39 Participants
|
87 participants
n=41 Participants
|
175 participants
n=35 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=39 Participants
|
14 participants
n=41 Participants
|
29 participants
n=35 Participants
|
|
Region of Enrollment
Ukraine
|
19 participants
n=39 Participants
|
19 participants
n=41 Participants
|
38 participants
n=35 Participants
|
|
Region of Enrollment
Russian Federation
|
55 participants
n=39 Participants
|
56 participants
n=41 Participants
|
111 participants
n=35 Participants
|
|
Duration of Diabetes
|
9.7 years
n=39 Participants
|
9.2 years
n=41 Participants
|
9.5 years
n=35 Participants
|
|
Weight
|
90.2 kg
n=39 Participants
|
90.8 kg
n=41 Participants
|
90.5 kg
n=35 Participants
|
|
BMI
|
31.8 kg/m^2
n=39 Participants
|
32.4 kg/m^2
n=41 Participants
|
32.1 kg/m^2
n=35 Participants
|
|
Fasting Plasma Glucose (FPG)
|
179.1 mg/dL
n=39 Participants
|
177.2 mg/dL
n=41 Participants
|
178.2 mg/dL
n=35 Participants
|
|
HbA1c
|
8.26 Percent of hemoglobin
n=39 Participants
|
8.35 Percent of hemoglobin
n=41 Participants
|
8.31 Percent of hemoglobin
n=35 Participants
|
|
Oral Anti-Diabetic Drug (OAD) Type
Metformin Only
|
42 participants
n=39 Participants
|
40 participants
n=41 Participants
|
82 participants
n=35 Participants
|
|
Oral Anti-Diabetic Drug (OAD) Type
Metformin + Sulfonylurea
|
114 participants
n=39 Participants
|
115 participants
n=41 Participants
|
229 participants
n=35 Participants
|
|
Oral Anti-Diabetic Drug (OAD) Type
Metformin + DPP-4 Inhibitor
|
9 participants
n=39 Participants
|
9 participants
n=41 Participants
|
18 participants
n=35 Participants
|
|
Oral Anti-Diabetic Drug (OAD) Type
Metformin + 1 or more OADs not specified above
|
9 participants
n=39 Participants
|
9 participants
n=41 Participants
|
18 participants
n=35 Participants
|
|
Oral Anti-Diabetic Drug (OAD) Type
2 or more OADs (not including Metformin)
|
3 participants
n=39 Participants
|
3 participants
n=41 Participants
|
6 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Change From Baseline to Week 24 in HbA1c
|
-0.82 percentage of hemoglobin
Standard Error 0.061
|
-0.42 percentage of hemoglobin
Standard Error 0.062
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set for subjects with available data at Week 24
Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 7.0%
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=151 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=142 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Proportion of Responders Achieving HbA1c <= 7.0%
|
37.7 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set for subjects with available data at Week 24
Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 6.5% at Week 24
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=151 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=142 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Proportion of Responders Achieving HbA1c <= 6.5%
|
15.9 percentage of participants
|
4.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set for subjects with data at both Baseline and at Week 24
Efficacy as measured by mean change in fasting plasma glucose (FPG)
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=139 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=128 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
FPG Change From Baseline to Week 24
|
-11.20 mg/dL
Standard Error 3.776
|
-3.78 mg/dL
Standard Error 3.864
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Proportion of Subjects Requiring Rescue Therapy
|
6.8 percentage of participants
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set
Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Time to Rescue
|
95 Days
Interval 22.0 to 141.0
|
85 Days
Interval 28.0 to 160.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set for patients with data at both Baseline and at Week 24
Forced Expiratory Volume in 1 second - change from baseline to week 24
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=141 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=122 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
FEV1 Change From Baseline to Week 24
|
-0.13 Liters
Standard Deviation 0.175
|
-0.04 Liters
Standard Deviation 0.147
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
Hypoglycemia, defined as blood glucose \<= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Incidence of Total Hypoglycemia
|
67.8 percentage of participants
|
30.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
Severe Hypoglycemia defined as: Requiring 3rd party assistance.
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Incidence of Severe Hypoglycemia
|
5.1 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Total Hypoglycemia Event Rate
|
1.16 Events/Subject-Month
|
0.50 Events/Subject-Month
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety population
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Severe Hypoglycemia Event Rate
|
2.37 Events/100 Subject-Month
|
0.60 Events/100 Subject-Month
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set
Mean 7-point self-monitored glucose at baseline
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=177 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=176 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Mean 7-point Glucose Baseline Values
Before Breakfast
|
178.5 mg/dL
Standard Deviation 37.58
|
182.2 mg/dL
Standard Deviation 40.50
|
|
Mean 7-point Glucose Baseline Values
After Breakfast
|
212.8 mg/dL
Standard Deviation 51.01
|
219.9 mg/dL
Standard Deviation 51.77
|
|
Mean 7-point Glucose Baseline Values
Before Lunch
|
176.7 mg/dL
Standard Deviation 49.58
|
183.6 mg/dL
Standard Deviation 53.76
|
|
Mean 7-point Glucose Baseline Values
After Lunch
|
197.0 mg/dL
Standard Deviation 46.94
|
209.1 mg/dL
Standard Deviation 44.37
|
|
Mean 7-point Glucose Baseline Values
Before Dinner
|
176.8 mg/dL
Standard Deviation 41.81
|
187.6 mg/dL
Standard Deviation 50.04
|
|
Mean 7-point Glucose Baseline Values
After Dinner
|
205.2 mg/dL
Standard Deviation 48.72
|
211.2 mg/dL
Standard Deviation 50.44
|
|
Mean 7-point Glucose Baseline Values
Bedtime
|
203.3 mg/dL
Standard Deviation 50.55
|
203.8 mg/dL
Standard Deviation 46.52
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set for patients with data at Week 24
Mean 7-point self-monitored blood glucose at Week 24
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=150 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=139 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Mean 7-point Glucose Week 24 Values
Before Breakfast
|
156.6 mg/dL
Standard Deviation 30.80
|
160.9 mg/dL
Standard Deviation 36.7
|
|
Mean 7-point Glucose Week 24 Values
After Breakfast
|
170.3 mg/dL
Standard Deviation 44.23
|
194.7 mg/dL
Standard Deviation 50.02
|
|
Mean 7-point Glucose Week 24 Values
Before Lunch
|
152.4 mg/dL
Standard Deviation 48.13
|
163.4 mg/dL
Standard Deviation 49.8
|
|
Mean 7-point Glucose Week 24 Values
After Lunch
|
158.0 mg/dL
Standard Deviation 42.79
|
183.8 mg/dL
Standard Deviation 47.73
|
|
Mean 7-point Glucose Week 24 Values
Before Dinner
|
157.4 mg/dL
Standard Deviation 49.34
|
164.7 mg/dL
Standard Deviation 40.60
|
|
Mean 7-point Glucose Week 24 Values
After Dinner
|
164.3 mg/dL
Standard Deviation 44.84
|
188.5 mg/dL
Standard Deviation 43.93
|
|
Mean 7-point Glucose Week 24 Values
Bedtime
|
163.0 mg/dL
Standard Deviation 42.66
|
178.7 mg/dL
Standard Deviation 44.50
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set for patients with data at both Baseline and at Week 24
Change in body weight from Baseline to Week 24
Outcome measures
| Measure |
TI Inhalation Powder + OADs
n=152 Participants
Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
Technosphere Powder
n=142 Participants
Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 24
|
0.49 kg
Standard Error 0.333
|
-1.13 kg
Standard Error 0.347
|
Adverse Events
TI Inhalation Powder
Serious events: 5 serious events
Other events: 108 other events
Deaths: 0 deaths
Technosphere Powder
Serious events: 9 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TI Inhalation Powder
n=177 participants at risk
Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere® Insulin: Technosphere® Insulin Inhalation Powder
|
Technosphere Powder
n=176 participants at risk
technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere Powder: Placebo Comparator
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Cardiac disorders
Myocardial Infarction
|
1.1%
2/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
Congenital, familial and genetic disorders
Skull Malformation
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.56%
1/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Investigations
Heart Rate Decreased
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.56%
1/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.56%
1/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
0.00%
0/177 • 24 Weeks
|
0.57%
1/176 • 24 Weeks
|
Other adverse events
| Measure |
TI Inhalation Powder
n=177 participants at risk
Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere® Insulin: Technosphere® Insulin Inhalation Powder
|
Technosphere Powder
n=176 participants at risk
technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs
Technosphere Powder: Placebo Comparator
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.7%
42/177 • 24 Weeks
|
19.9%
35/176 • 24 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
15/177 • 24 Weeks
|
4.5%
8/176 • 24 Weeks
|
|
Infections and infestations
Influenza
|
5.6%
10/177 • 24 Weeks
|
1.7%
3/176 • 24 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.1%
9/177 • 24 Weeks
|
2.8%
5/176 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.5%
8/177 • 24 Weeks
|
2.3%
4/176 • 24 Weeks
|
|
Nervous system disorders
Headache
|
4.0%
7/177 • 24 Weeks
|
2.8%
5/176 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
6/177 • 24 Weeks
|
1.7%
3/176 • 24 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
6/177 • 24 Weeks
|
1.1%
2/176 • 24 Weeks
|
|
Infections and infestations
Bronchitis
|
2.8%
5/177 • 24 Weeks
|
4.0%
7/176 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
2.3%
4/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
General disorders
Oedema Peripheral
|
2.3%
4/177 • 24 Weeks
|
0.00%
0/176 • 24 Weeks
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
1.1%
2/177 • 24 Weeks
|
2.8%
5/176 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/177 • 24 Weeks
|
2.8%
5/176 • 24 Weeks
|
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