Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01196104
Recruitment Status : Terminated (For Business Reasons)
First Posted : September 8, 2010
Results First Posted : October 21, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Technosphere® Insulin Inhalation Powder
Drug: Insulin Aspart
Drug: Insulin Glargine
Enrollment 39
Recruitment Details The FIrst Patient First Visit (FPFV) was September 21, 2010, and Last Patient Last Visit (LPLV) was August 25, 2011. Trial conducted in US. The study was terminated before completion of full enrollment for business reasons. Subjects already enrolled were allowed to complete the study to assess the safety of the titration algorithms.
Pre-assignment Details

After a 1 week to 5 week run-in period, subjects were randomized to receive either TI Inhalation Powder in combination with insulin glargine, or insulin aspart in combination with insulin glargine.

105 Screened/46 Eligible. 39 subjects were randomized; 59 screen failures and 7 were screened but not randomized.

Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Period Title: Overall Study
Started 19 20
Completed 15 15
Not Completed 4 5
Reason Not Completed
Lost to Follow-up             1             0
Physician Decision             0             1
Withdrawal by Subject             3             3
Various             0             1
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine Total
Hide Arm/Group Description Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient Total of all reporting groups
Overall Number of Baseline Participants 19 18 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 18 participants 37 participants
60.6
(47 to 72)
58.1
(42 to 78)
59.4
(42 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
Female
8
  42.1%
4
  22.2%
12
  32.4%
Male
11
  57.9%
14
  77.8%
25
  67.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  16.7%
3
   8.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.6%
1
   2.7%
Black or African American
4
  21.1%
3
  16.7%
7
  18.9%
White
15
  78.9%
11
  61.1%
26
  70.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 18 participants 37 participants
19 18 37
Duration of Diabetes  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 18 participants 37 participants
14.6
(3.7 to 35.9)
15.6
(2.5 to 43.1)
15.1
(2.5 to 43.1)
Body Weight   [1] 
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 19 participants 18 participants 37 participants
100.9
(54.1 to 141.9)
100.8
(66.4 to 138.6)
100.9
(54.1 to 141.9)
[1]
Measure Description: Body Weight (kg) at Randomization
Body Mass Index   [1] 
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 19 participants 18 participants 37 participants
33.2
(19.3 to 42.9)
33.3
(24.3 to 44.1)
33.2
(19.3 to 44.1)
[1]
Measure Description: Body Mass Index (kg/m2) at Randomization
HbA1c   [1] 
Mean (Full Range)
Unit of measure:  %
Number Analyzed 19 participants 18 participants 37 participants
7.76
(6.3 to 10.2)
7.94
(6.7 to 10.3)
7.85
(6.3 to 10.3)
[1]
Measure Description: HbA1c (%) at randomization (NOTE: Aspart group only had 17 with HbA1c measurements at baseline)
1.Primary Outcome
Title Change in HbA1c (%) From Baseline to Week 16
Hide Description Change from Baseline in glycated hemoglobin at Week 16
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, participants with data available at Baseline and Week 16
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 16 14
Least Squares Mean (Standard Deviation)
Unit of Measure: Percentage of total hemoglobin
-1.2179  (0.1468) -1.2652  (0.1571)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Aspart + Insulin Glargine
Comments ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate
Type of Statistical Test Non-Inferiority or Equivalence
Comments Study terminated early due to business reasons, results are not properly powered.
Statistical Test of Hypothesis P-Value 0.8283
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0473
Confidence Interval (2-Sided) 95%
-0.4901 to 0.3956
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2158
Estimation Comments [Not Specified]
2.Secondary Outcome
Title To Evaluate the Effect of Each Treatment on HbA1c
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Glycomark and Fructosamine Levels Measured Throughout the Study
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Seven-point Glucose at Randomization and Throughout the Study
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Changes in Body Weight at 16 Weeks
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires
Hide Description Not analyzed due to early termination of the trial.
Time Frame Change from baseline to 16 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Total Number of Cough Episodes
Hide Description Total number of times patients coughed once, intermittently or continuously (inclusive)
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Cough episodes
5 0
11.Secondary Outcome
Title Severe Hypoglycemic Event Rate
Hide Description

Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation

Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:

  • SMBG levels ≤ 36 mg/dL OR
  • There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Events / subject-month
0.01 0.34
12.Secondary Outcome
Title Mild or Moderate Hypoglycemic Event Rate
Hide Description

Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation

Nonsevere hypoglycemia is defined as a subject:

  • SMBG levels < 70 mg/dL AND/OR
  • Symptoms that are relieved by the self-administration of carbohydrates
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere® Insulin Inhalation Powder (TI) Comparator
Hide Arm/Group Description:

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Technosphere® Insulin Inhalation Powder

Insulin Glargine

Insulin Glargine and Insulin Aspart

Insulin Aspart: Usual Care

Insulin Glargine

Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Events / subject-month
4.47 4.41
13.Secondary Outcome
Title Number of Subjects Reporting Cough Episodes
Hide Description Number of Subjects Reporting Cough Episodes
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Number of participants
4 0
14.Secondary Outcome
Title Number of Subjects Reporting Intermittent Coughing Episodes
Hide Description Number of subjects reporting Intermittent Coughing Episodes
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Number of participants
4 0
15.Secondary Outcome
Title Number of Single Coughing Episodes
Hide Description Total number of times patients coughed only once
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Cough episodes
1 0
16.Secondary Outcome
Title Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Hide Description [Not Specified]
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Cough episodes
5 0
17.Secondary Outcome
Title Baseline Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Baseline FEV1
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: L
2.97  (0.63) 2.83  (0.75)
18.Secondary Outcome
Title Week 16 Forced Expiratory Volume in 1 Second
Hide Description Week 16 FEV1
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 16
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: L
2.91  (0.57) 2.66  (0.70)
19.Secondary Outcome
Title Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Hide Description Week 16 Change from Baseline in FEV1
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 16
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: L
-0.14  (0.32) -0.07  (0.27)
20.Secondary Outcome
Title Week 20 (Follow-up) Forced Expiratory Volume in 1 Second
Hide Description Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment
Time Frame Week 20 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 20
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: L
3.07  (0.55) 2.86  (0.70)
21.Secondary Outcome
Title Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second
Hide Description Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 20
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: L
-0.07  (0.29) -0.05  (0.28)
22.Secondary Outcome
Title Baseline Forced Vital Capacity (FVC)
Hide Description Baseline FVC
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: L
3.63  (0.78) 3.48  (1.02)
23.Secondary Outcome
Title Week 16 Forced Vital Capacity
Hide Description Week 16 FVC
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 16
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: L
3.61  (0.72) 3.33  (0.98)
24.Secondary Outcome
Title Week 16 Change From Baseline Forced Vital Capacity
Hide Description Week 16 Change from Baseline FVC
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 16
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: L
-0.13  (0.34) -0.07  (0.36)
25.Secondary Outcome
Title Week 20 (Follow-up) Forced Vital Capacity
Hide Description Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 20
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: L
3.77  (0.73) 3.57  (0.96)
26.Secondary Outcome
Title Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity
Hide Description Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC
Time Frame Baseline to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, with data available at Week 20
Arm/Group Title Technosphere Insulin + Insulin Glargine Insulin Aspart + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: L
-0.05  (0.35) -0.06  (0.38)
Time Frame From first dose to 30d post last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Technosphere® Insulin Inhalation Powder (TI) Comparator
Hide Arm/Group Description

Insulin Glargine and Technosphere® Insulin Inhalation Powder

Technosphere® Insulin Inhalation Powder

Insulin Glargine

Insulin Glargine and Insulin Aspart

Insulin Aspart: Usual Care

Insulin Glargine

All-Cause Mortality
Technosphere® Insulin Inhalation Powder (TI) Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Technosphere® Insulin Inhalation Powder (TI) Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   1/18 (5.56%) 
Cardiac disorders     
Angina unstable  1  0/19 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
Rib Fracture  1  1/19 (5.26%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Technosphere® Insulin Inhalation Powder (TI) Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   13/19 (68.42%)   11/18 (61.11%) 
Cardiac disorders     
Angina Pectoris  1  1/19 (5.26%)  0/18 (0.00%) 
Atrial Fibrillation  1  0/19 (0.00%)  1/18 (5.56%) 
Ventricular extrasystoles  1  0/19 (0.00%)  1/18 (5.56%) 
Endocrine disorders     
Hypothyroidism  1  1/19 (5.26%)  0/18 (0.00%) 
Eye disorders     
Mydriasis  1  0/19 (0.00%)  1/18 (5.56%) 
Vitreous haemorrhage  1  0/19 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/19 (0.00%)  1/18 (5.56%) 
Diarrhea  1  0/19 (0.00%)  1/18 (5.56%) 
General disorders     
Oedema  1  0/19 (0.00%)  1/18 (5.56%) 
Oedema Peripheral  1  0/19 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  4/19 (21.05%)  1/18 (5.56%) 
Ear Infection  1  1/19 (5.26%)  0/18 (0.00%) 
Onychomycosis  1  1/19 (5.26%)  0/18 (0.00%) 
Sinusitis  1  1/19 (5.26%)  0/18 (0.00%) 
Urinary Tract Infection  1  1/19 (5.26%)  0/18 (0.00%) 
Nasopharyngitis  1  0/19 (0.00%)  1/18 (5.56%) 
Pharyngitis  1  0/19 (0.00%)  1/18 (5.56%) 
Investigations     
Blood Testosterone Decreased  2  1/19 (5.26%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/19 (10.53%)  2/18 (11.11%) 
Back Pain  1  1/19 (5.26%)  0/18 (0.00%) 
Chest Wall Pain  1  0/19 (0.00%)  1/18 (5.56%) 
Plantar Fasciitis  1  0/19 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Dizziness  1  0/19 (0.00%)  1/18 (5.56%) 
Headache  1  0/19 (0.00%)  1/18 (5.56%) 
Hypoaesthesia  1  0/19 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
Depression  1  0/19 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders     
Renal Failure  1  0/19 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/19 (21.05%)  0/18 (0.00%) 
Sinus Congestion  1  1/19 (5.26%)  0/18 (0.00%) 
Throat Irritation  1  1/19 (5.26%)  0/18 (0.00%) 
Dry Throat  1  0/19 (0.00%)  1/18 (5.56%) 
Dyspnoea  1  0/19 (0.00%)  1/18 (5.56%) 
Productive Cough  1  0/19 (0.00%)  1/18 (5.56%) 
Respiratory Tract Congestion  1  0/19 (0.00%)  1/18 (5.56%) 
Wheezing  1  0/19 (0.00%)  1/18 (5.56%) 
Surgical and medical procedures     
Cataract Operation  1  0/19 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hypertension  1  1/19 (5.26%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
2
Term from vocabulary, MedDRA15.1
- Early termination of trial leading to small numbers of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: MannKind Corporation
Phone: 201-983-5000
Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01196104     History of Changes
Other Study ID Numbers: MKC-TI-162
First Submitted: August 30, 2010
First Posted: September 8, 2010
Results First Submitted: July 22, 2014
Results First Posted: October 21, 2014
Last Update Posted: October 30, 2014