Trial Outcomes & Findings for Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks (NCT NCT00700622)
NCT ID: NCT00700622
Last Updated: 2014-10-16
Results Overview
Change from Baseline in glycosylated hemoglobin at Week 16
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2014-10-16
Participant Flow
The FPFV was May 30, 2008. Multinational trial conducted in the US and Brazil.
2 week screening period prior to randomization - 276 Screened / 138 Eligible. 130 subjects were randomized; 138 screen failures and 8 discontinued prior to randomization.
Participant milestones
| Measure |
TI + Insulin Glargine
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
52
|
60
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
TI + Insulin Glargine
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Other
|
3
|
1
|
Baseline Characteristics
Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks
Baseline characteristics by cohort
| Measure |
TI + Insulin Glargine
n=65 Participants
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
n=65 Participants
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Weight
|
74.49 kg
STANDARD_DEVIATION 13.270 • n=5 Participants
|
74.18 kg
STANDARD_DEVIATION 13.894 • n=7 Participants
|
74.3 kg
STANDARD_DEVIATION 13.53 • n=5 Participants
|
|
Height
|
172.22 cm
STANDARD_DEVIATION 9.238 • n=5 Participants
|
169.61 cm
STANDARD_DEVIATION 9.807 • n=7 Participants
|
170.9 cm
STANDARD_DEVIATION 9.579 • n=5 Participants
|
|
Body Mass Index
|
25.07 kg/m^2
STANDARD_DEVIATION 3.744 • n=5 Participants
|
25.63 kg/m^2
STANDARD_DEVIATION 3.141 • n=7 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 3.454 • n=5 Participants
|
|
HbA1c
|
7.76 %
STANDARD_DEVIATION 0.550 • n=5 Participants
|
7.62 %
STANDARD_DEVIATION 0.602 • n=7 Participants
|
7.69 %
STANDARD_DEVIATION 0.579 • n=5 Participants
|
|
Waist Circumference
|
86.26 cm
STANDARD_DEVIATION 10.445 • n=5 Participants
|
87.31 cm
STANDARD_DEVIATION 10.669 • n=7 Participants
|
86.78 cm
STANDARD_DEVIATION 10.530 • n=5 Participants
|
|
Fasting Blood Glucose
|
178.06 mg/dL
STANDARD_DEVIATION 76.916 • n=5 Participants
|
176.20 mg/dL
STANDARD_DEVIATION 67.268 • n=7 Participants
|
177.15 mg/dL
STANDARD_DEVIATION 72.084 • n=5 Participants
|
|
Race
Caucasian
|
56 participants
n=5 Participants
|
59 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Race
Black
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race
Hispanic
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Intent to Treat with Available Data at Week 16
Change from Baseline in glycosylated hemoglobin at Week 16
Outcome measures
| Measure |
TI + Insulin Glargine
n=52 Participants
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
n=58 Participants
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
|---|---|---|
|
Change From Baseline in HbA1c to Week 16
|
-0.10 percentage of total hemoglobin
Standard Error 0.087
|
-0.03 percentage of total hemoglobin
Standard Error 0.082
|
Adverse Events
TI + Insulin Glargine
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Insulin Lispro + Insulin Glargine
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TI + Insulin Glargine
n=65 participants at risk
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
n=65 participants at risk
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Delayed recovery from anesthesia
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
1.5%
1/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
1.5%
1/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.5%
1/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
3.1%
2/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Metabolism and nutrition disorders
Hypoglycemic seizure
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
1.5%
1/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
1.5%
1/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
Other adverse events
| Measure |
TI + Insulin Glargine
n=65 participants at risk
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
|
Insulin Lispro + Insulin Glargine
n=65 participants at risk
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.6%
29/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Endocrine disorders
Hypoglycaemia
|
32.3%
21/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
35.4%
23/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Infections and infestations
Sinusitis
|
7.7%
5/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
3.1%
2/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
5/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
9.2%
6/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
General disorders
Chest discomfort
|
6.2%
4/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
0.00%
0/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
4/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
3.1%
2/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Infections and infestations
Influenza
|
4.6%
3/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
16.9%
11/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
|
6.2%
4/65 • SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post 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 multicenter Study publication, PI may publish the study results subject to MNKD rights herein.
- Publication restrictions are in place
Restriction type: OTHER