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Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01451398
First received: October 7, 2011
Last updated: October 9, 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: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Technosphere® Insulin
Drug: Technosphere Powder

  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 November 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
6 week Screening Period prior to OAD run-in period. 1379 Screened /539 Eligible of which 535 entered the run-in period. 439 met randomization criteria at end of run-in of which 353 were randomized.

Reporting Groups
  Description
TI Inhalation Powder + OADs Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
Technosphere Powder Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient

Participant Flow:   Overall Study
    TI Inhalation Powder + OADs   Technosphere Powder
STARTED   177   176 
COMPLETED   150   139 
NOT COMPLETED   27   37 
Adverse Event                7                9 
Protocol Violation                1                2 
Physician Decision                1                1 
Withdrawal by Subject                10                14 
Lost to Follow-up                6                4 
Non-compliance with study drug                1                3 
Non-compliance with protocol                1                1 
Moved out of country                0                1 
Adverse Event + Elevated Fasting Glucose                0                1 
Lack of Efficacy                0                1 



  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.
Safety population

Reporting Groups
  Description
TI Inhalation Powder + OADs Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
Technosphere Powder Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
Total Total of all reporting groups

Baseline Measures
   TI Inhalation Powder + OADs   Technosphere Powder   Total 
Overall Participants Analyzed 
[Units: Participants]
 177   176   353 
Age, Customized 
[Units: Participants]
     
18-30 years   1   0   1 
31-49 years   37   33   70 
50-64 years   102   110   212 
>=65 years   37   33   70 
Gender 
[Units: Participants]
     
Female   95   102   197 
Male   82   74   156 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   1   2 
Asian   1   2   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   21   17   38 
White   151   155   306 
More than one race   0   0   0 
Unknown or Not Reported   3   1   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   43   41   84 
Not Hispanic or Latino   134   135   269 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   88   87   175 
Brazil   15   14   29 
Ukraine   19   19   38 
Russian Federation   55   56   111 
Duration of Diabetes 
[Units: Years]
Mean (Full Range)
 9.7 
 (1.1 to 34.7) 
 9.2 
 (1.0 to 28.8) 
 9.5 
 (1.0 to 34.7) 
Weight 
[Units: Kg]
Mean (Full Range)
 90.2 
 (54.0 to 142.3) 
 90.8 
 (58.0 to 136.6) 
 90.5 
 (54.0 to 142.3) 
BMI 
[Units: Kg/m^2]
Mean (Full Range)
 31.8 
 (21.6 to 44.6) 
 32.4 
 (21.1 to 44.4) 
 32.1 
 (21.1 to 44.6) 
Fasting Plasma Glucose (FPG) 
[Units: mg/dL]
Mean (Full Range)
 179.1 
 (49 to 306) 
 177.2 
 (54 to 316) 
 178.2 
 (49 to 316) 
HbA1c 
[Units: Percent of hemoglobin]
Mean (Full Range)
 8.26 
 (6.6 to 10.1) 
 8.35 
 (5.1 to 10.9) 
 8.31 
 (5.1 to 10.9) 
Oral Anti-Diabetic Drug (OAD) Type 
[Units: Participants]
     
Metformin Only   42   40   82 
Metformin + Sulfonylurea   114   115   229 
Metformin + DPP-4 Inhibitor   9   9   18 
Metformin + 1 or more OADs not specified above   9   9   18 
2 or more OADs (not including Metformin)   3   3   6 


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

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

3.  Secondary:   Proportion of Responders Achieving HbA1c <= 6.5%   [ Time Frame: Week 24 ]

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

5.  Secondary:   Proportion of Subjects Requiring Rescue Therapy   [ Time Frame: Baseline to Week 24 ]

6.  Secondary:   Time to Rescue   [ Time Frame: Baseline to Week 24 ]

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

8.  Secondary:   Incidence of Total Hypoglycemia   [ Time Frame: Baseline to Week 24 ]

9.  Secondary:   Incidence of Severe Hypoglycemia   [ Time Frame: Baseline to Week 24 ]

10.  Secondary:   Total Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]

11.  Secondary:   Severe Hypoglycemia Event Rate   [ Time Frame: Baseline to Week 24 ]

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

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

14.  Secondary:   Change in Body Weight From Baseline to Week 24   [ 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: NCT01451398     History of Changes
Other Study ID Numbers: MKC-TI-175
Affinity2
Study First Received: October 7, 2011
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration