Trial Outcomes & Findings for Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up (NCT NCT00309244)
NCT ID: NCT00309244
Last Updated: 2014-10-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
677 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2014-10-16
Participant Flow
First subject enrolled Feb. 23, 2006 Multi-national trial conducted in US, Canada, Mexico, Brazil, Argentina, Chile, Spain, UK, Poland, Russia
3 week Screening period prior to randomization - 2064 Screened / 673 Eligible . 677 subjects were randomized. ( 4 ineligible subjects were randomized in error) 1391 screen failures. 23 Subjects randomized but never dosed.
Participant milestones
| Measure |
TI + Insulin Glargine
Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
|
BPR 70/30
70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
|
|---|---|---|
|
Overall Study
STARTED
|
334
|
343
|
|
Overall Study
COMPLETED
|
216
|
246
|
|
Overall Study
NOT COMPLETED
|
118
|
97
|
Reasons for withdrawal
| Measure |
TI + Insulin Glargine
Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
|
BPR 70/30
70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
|
|---|---|---|
|
Overall Study
Adverse Event
|
29
|
12
|
|
Overall Study
Lost to Follow-up
|
6
|
22
|
|
Overall Study
Physician Decision
|
5
|
8
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
50
|
32
|
|
Overall Study
Various
|
7
|
7
|
|
Overall Study
Randomized but not dosed
|
11
|
12
|
|
Overall Study
Death
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
Baseline characteristics by cohort
| Measure |
TI + Insulin Glargine
n=323 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.91 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
171.8 milligrams per deciliter
STANDARD_DEVIATION 68.53 • n=5 Participants
|
176.2 milligrams per deciliter
STANDARD_DEVIATION 67.15 • n=7 Participants
|
174 milligrams per deciliter
STANDARD_DEVIATION 67.82 • n=5 Participants
|
|
HbA1c
|
8.7 percentage
STANDARD_DEVIATION 1.14 • n=5 Participants
|
8.7 percentage
STANDARD_DEVIATION 1.10 • n=7 Participants
|
8.7 percentage
STANDARD_DEVIATION 1.12 • n=5 Participants
|
|
Weight
|
88.1 kilogram
STANDARD_DEVIATION 17.33 • n=5 Participants
|
85.7 kilogram
STANDARD_DEVIATION 18.07 • n=7 Participants
|
86.9 kilogram
STANDARD_DEVIATION 17.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Intention to treat (ITT) with Last Observation Carried Forward (LOCF); participants with available data at baseline and post-baseline.
Outcome measures
| Measure |
TI + Insulin Glargine
n=302 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=316 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Change From Baseline in HbA1c to Week 52
|
-0.59 percent
Standard Error 0.063
|
-0.71 percent
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intention to treat (ITT) population; participants with available data at baseline and Week 52.
Outcome measures
| Measure |
TI + Insulin Glargine
n=194 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=227 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Change From Baseline in Weight to Week 52
|
0.9 kilogram
Standard Error 0.32
|
2.5 kilogram
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intention to treat (ITT) population; participants with available data at baseline and Week 52.
Outcome measures
| Measure |
TI + Insulin Glargine
n=197 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=218 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose to Week 52
|
-35.7 milligrams per deciliter
Standard Error 4.61
|
-17.9 milligrams per deciliter
Standard Error 4.21
|
SECONDARY outcome
Timeframe: Week 52Population: Intention to treat (ITT); participants with available data at baseline and Week 52.
Outcome measures
| Measure |
TI + Insulin Glargine
n=213 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=243 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
|
47 participants
|
65 participants
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Safety Population
Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.
Outcome measures
| Measure |
TI + Insulin Glargine
n=323 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Incidence of Total Hypoglycemia
|
47.99 percentage of participants
|
68.58 percentage of participants
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Safety Population
Severe hypoglycemia occurs when all 3 of the following occur simultaneously: * Subject requires the assistance of another person; * Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); * Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, * Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.
Outcome measures
| Measure |
TI + Insulin Glargine
n=323 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Incidence of Severe Hypoglycemia
|
4.33 percentage of participants
|
9.97 percentage of participants
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Safety Population
Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Outcome measures
| Measure |
TI + Insulin Glargine
n=323 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Total Hypoglycemia Event Rate
|
0.41 Number of events/subject-month
|
0.61 Number of events/subject-month
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Safety Population
Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
Outcome measures
| Measure |
TI + Insulin Glargine
n=323 Participants
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 Participants
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Severe Hypoglycemia Event Rate
|
0.73 Number of events/100 subject-months
|
2.20 Number of events/100 subject-months
|
Adverse Events
TI + Insulin Glargine
Serious events: 37 serious events
Other events: 225 other events
Deaths: 0 deaths
BPR 70/30
Serious events: 31 serious events
Other events: 251 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TI + Insulin Glargine
n=323 participants at risk
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 participants at risk
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
2/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Cardiac failure acute
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Coronary artery atherosclerosis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Coronary artery disease
|
0.62%
2/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Coronary artery occlusion
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Cardiac disorders
Ventricular tachycardia
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Eye disorders
Optic atrophy
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Eye disorders
Retinal detachment
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Eye disorders
Vitreous haemorrhage
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Constipation
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
General disorders
Chest pain
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
General disorders
Oedema peripheral
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
General disorders
Pyrexia
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Immune system disorders
Autoimmune disorder
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Appendicitis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Diabetic foot infection
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Endocarditis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Gangrene
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Gastroenteritis viral
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Hepatitis viral
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Localised infection
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Staphylococcal sepsis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Wound infection
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.60%
2/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Injury
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Investigations
International normalised ratio increased
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
3/323 • From first dose to 30 days after last dose
|
1.8%
6/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage iii
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Ataxia
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Dizziness
|
0.62%
2/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Encephalitis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Loss of consciousness
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.91%
3/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Syncope
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Psychiatric disorders
Psychotic disorder
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Renal and urinary disorders
Renal failure acute
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.31%
1/323 • From first dose to 30 days after last dose
|
0.00%
0/331 • From first dose to 30 days after last dose
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
|
Vascular disorders
Thrombosis
|
0.00%
0/323 • From first dose to 30 days after last dose
|
0.30%
1/331 • From first dose to 30 days after last dose
|
Other adverse events
| Measure |
TI + Insulin Glargine
n=323 participants at risk
Technosphere® Insulin Inhalation Powder + Insulin glargine
|
BPR 70/30
n=331 participants at risk
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
39/323 • From first dose to 30 days after last dose
|
7.3%
24/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
30/323 • From first dose to 30 days after last dose
|
8.5%
28/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Influenza
|
5.6%
18/323 • From first dose to 30 days after last dose
|
5.4%
18/331 • From first dose to 30 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
3.1%
10/323 • From first dose to 30 days after last dose
|
6.3%
21/331 • From first dose to 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
48.0%
155/323 • From first dose to 30 days after last dose
|
68.9%
228/331 • From first dose to 30 days after last dose
|
|
Nervous system disorders
Headache
|
5.6%
18/323 • From first dose to 30 days after last dose
|
3.6%
12/331 • From first dose to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.8%
106/323 • From first dose to 30 days after last dose
|
6.0%
20/331 • From first dose to 30 days after last dose
|
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 multi-center Study publication, PI may publish the Study results subject to MNKD rights herein.
- Publication restrictions are in place
Restriction type: OTHER