Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308737
First received: March 28, 2006
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 Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes, Type 1
Diabetes, Type 2
Interventions: Drug: Technosphere® Insulin Inhalation Powder
Drug: Usual Care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled July 25, 2005 Multi-national trial conducted in Canada, Czech Republic, Poland, Russia, Spain, Ukraine, UK, and US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects were required to meet all inclusion/exclusion criteria 3741 screened/2053 eligible of which all were randomized, including 164 non-diabetics - 1688 screen failures

17 diabetics randomized but not dosed

1 non-diabetic elected not to participate


Reporting Groups
  Description
Technosphere® Insulin Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
Usual Care Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
Non-diabetes Subjects without abnormalities in glucose control

Participant Flow:   Overall Study
    Technosphere® Insulin     Usual Care     Non-diabetes  
STARTED     938     951     164  
COMPLETED     475     662     127  
NOT COMPLETED     463     289     37  
Adverse Event                 104                 9                 0  
Death                 4                 3                 0  
Lost to Follow-up                 56                 80                 5  
Physician Decision                 15                 2                 1  
Protocol Violation                 34                 9                 5  
Withdrawal by Subject                 218                 166                 18  
Various                 32                 20                 8  



  Baseline Characteristics
  Hide Baseline Characteristics

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, excluding subjects who were not dosed with study medication (17 diabetics randomized but not dosed, 1 non-diabetic elected not to participate)

Reporting Groups
  Description
Technosphere® Insulin Technosphere Insulin
Usual Care Usual care
Non-diabetes Subjects without abnormalities in glucose control
Total Total of all reporting groups

Baseline Measures
    Technosphere® Insulin     Usual Care     Non-diabetes     Total  
Number of Participants  
[units: participants]
  923     949     163     2035  
Age  
[units: years]
Mean ± Standard Deviation
  50.8  ± 11.55     50.4  ± 11.62     38.2  ± 12.59     49.6  ± 12.15  
Gender  
[units: participants]
       
Female     366     371     92     829  
Male     557     578     71     1206  
Body mass index [1]
[units: kilograms per meter squared]
Mean ± Standard Deviation
  29.87  ± 5.366     29.76  ± 5.035     25.27  ± 4.494     29.5  ± 5.29  
HbA1c [2]
[units: percentage]
Mean ± Standard Deviation
  8.7  ± 1.39     8.7  ± 1.38     0  ± 0     8.4  ± 1.61  
Weight [3]
[units: kilograms]
Mean ± Standard Deviation
  87.69  ± 18.628     87.53  ± 17.638     74.35  ± 16.204     86.6  ± 18.33  
[1] Body mass index
[2] Glycated hemoglobin
[3] Weight in kilograms



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care   [ Time Frame: Baseline to Month 24 ]

2.  Primary:   FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care   [ Time Frame: Baseline to Month 24 ]

3.  Secondary:   Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care   [ Time Frame: Baseline to Month 24 ]

4.  Secondary:   Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM   [ Time Frame: Baseline to Month 24 ]

5.  Secondary:   Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM   [ Time Frame: Baseline to Month 24 ]

6.  Secondary:   Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM   [ Time Frame: Baseline to Month 24 ]

7.  Secondary:   Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement   [ Time Frame: Baseline to Month 24 ]

8.  Secondary:   Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement   [ Time Frame: Baseline to Month 24 ]

9.  Secondary:   Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement   [ Time Frame: Baseline to Month 24 ]

10.  Secondary:   Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement   [ Time Frame: Baseline to Month 24 ]

11.  Secondary:   Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care   [ Time Frame: Baseline to Month 24 ]

12.  Secondary:   Change in Weight From Baseline at Month 24   [ Time Frame: Baseline to Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00308737     History of Changes
Other Study ID Numbers: MKC-TI-030
Study First Received: March 28, 2006
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration