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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 24 in HbA1c   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:   FEV1 Change From Baseline to Week 24   [ Time Frame: Baseline to Week 24 ]

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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