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Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01445951
First received: September 30, 2011
Last updated: October 20, 2014
Last verified: October 2014
History of Changes
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Technosphere® Insulin with MedTone C Inhaler
Drug: Technosphere ®Insulin with Gen2 Inhaler
Drug: Insulin Aspart in combination with a basal insulin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 week Screening Period prior to run-in (basal insulin optimization period). 1401 Screened / 621 Eligible of which 614 entered the run-in period. 538 met randomization criteria at end of run-in of which 518 were randomized.

Reporting Groups
  Description
Technosphere Insulin-Gen2 + Basal Insulin Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Technosphere Insulin-MedTone + Basal Insulin Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Insulin Aspart + Basal Insulin Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient

Participant Flow:   Overall Study
    Technosphere Insulin-Gen2 + Basal Insulin     Technosphere Insulin-MedTone + Basal Insulin     Insulin Aspart + Basal Insulin  
STARTED     174     174     170  
COMPLETED     130     138     151  
NOT COMPLETED     44     36     19  
Adverse Event                 16                 9                 0  
Protocol Violation                 2                 2                 2  
Withdrawal by Subject                 21                 16                 8  
Physician Decision                 3                 1                 0  
Lost to Follow-up                 1                 2                 4  
Pregnancy                 0                 1                 4  
Death                 0                 0                 1  
Non-compliance with study drug                 1                 2                 0  
Non-compliance with protocol                 0                 1                 0  
Sponsor decision - subject travel                 0                 1                 0  
Cough                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups
  Description
Technosphere Insulin-Gen2 + Basal Insulin Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Technosphere Insulin-MedTone + Basal Insulin Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
Insulin Aspart + Basal Insulin Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
Total Total of all reporting groups

Baseline Measures
    Technosphere Insulin-Gen2 + Basal Insulin     Technosphere Insulin-MedTone + Basal Insulin     Insulin Aspart + Basal Insulin     Total  
Number of Participants  
[units: participants]
 		  174     174     170     518  
Age, Customized  
[units: participants]
 		       
18-30 years     56     48     46     150  
31-49 years     93     84     88     265  
50-64 years     18     33     28     79  
>= 65 years     7     9     8     24  
Gender  
[units: participants]
 		       
Female     97     94     96     287  
Male     77     80     74     231  
Ethnicity (NIH/OMB)  
[units: participants]
 		       
Hispanic or Latino     17     22     18     57  
Not Hispanic or Latino     157     152     152     461  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		       
American Indian or Alaska Native     0     0     0     0  
Asian     1     1     0     2  
Native Hawaiian or Other Pacific Islander     1     0     0     1  
Black or African American     8     5     3     16  
White     164     167     166     497  
More than one race     0     0     0     0  
Unknown or Not Reported     0     1     1     2  
Region of Enrollment  
[units: participants]
 		       
United States     71     69     67     207  
Brazil     14     15     13     42  
Ukraine     44     38     38     120  
Russian Federation     45     52     52     149  
Duration of Diabetes  
[units: years]
Mean (Full Range) 		  16.0  
  (1.1 to 57.3)   		  17.7  
  (1.1 to 49.5)   		  16.7  
  (1.0 to 42.2)   		  16.8  
  (1.0 to 57.3)  
Weight  
[units: kg]
Mean (Full Range) 		  75.7  
  (41.7 to 129.4)   		  76.8  
  (47.6 to 124.0)   		  72.6  
  (46.6 to 120.2)   		  75.1  
  (41.7 to 129.4)  
BMI  
[units: kg/m^2]
Mean (Full Range) 		  26.0  
  (16.6 to 38.6)   		  26.2  
  (18.1 to 36.4)   		  25.4  
  (17.4 to 37.2)   		  25.9  
  (16.6 to 38.6)  
Fasting Plasma Glucose  
[units: mg/dL]
Mean (Full Range) 		  155.0  
  (21.0 to 403.0)   		  144.3  
  (43.0 to 358.0)   		  151.2  
  (23.0 to 375.0)   		  150.2  
  (21.0 to 403.0)  
HbA1c  
[units: Percent of hemoglobin]
Mean (Full Range) 		  7.98  
  (6.20 to 10.60)   		  8.00  
  (6.10 to 10.20)   		  7.88  
  (5.80 to 10.10)   		  7.95  
  (5.80 to 10.60)  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 24 in HbA1c   [ Time Frame: Baseline to Week 24 ]
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2.  Secondary:   FEV1 Change From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 2

3.  Secondary:   FPG Change From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Mean 7-point Glucose Baseline Values   [ Time Frame: Baseline ]
  Show Outcome Measure 4

5.  Secondary:   Mean 7-point Glucose Week 24 Values   [ Time Frame: Week 24 ]
  Show Outcome Measure 5

6.  Secondary:   Change in Body Weight From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 6

7.  Secondary:   Proportion of Responders Achieving HbA1c <= 7.0%   [ Time Frame: Week 24 ]
  Show Outcome Measure 7

8.  Other Pre-specified:   Incidence of Total Hypoglycemia   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 8

9.  Other Pre-specified:   Incidence of Severe Hypoglycemia   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 9

10.  Other Pre-specified:   Total Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 10

11.  Other Pre-specified:   Severe Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: MannKind Corporation
phone: 201-983-5000
e-mail: aboss@mannkindcorp.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01445951     History of Changes
Other Study ID Numbers: MKC-TI-171
Study First Received: September 30, 2011
Results First Received: July 22, 2014
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration