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Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease

This study has been terminated.
(Terminated upon recommendation of the Data Safety Monitoring Board (DSMB))
Sponsor:
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00642616
First received: March 21, 2008
Last updated: February 12, 2016
Last verified: February 2016
Results First Received: November 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Moderate Chronic Obstructive Pulmonary Disease
Asthma
Interventions: Drug: Technosphere® Insulin
Drug: Usual Care

  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
A total of 517 participants were screened in 5 countries . First participant was screened in March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 week screening period followed by a 2 week run-in period. After the screening period, 51 participants were randomized and 34 participants met eligibility criteria after the 2 week run-in period and were treated . Study was terminated based on data safety monitoring board recommendations.

Reporting Groups
  Description
Technosphere® Insulin (Asthma) Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
Usual Care (Asthma) Usual and anti diabetic care in diabetic participants with Asthma.
Technosphere® Insulin (COPD) Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
Usual Care (COPD) Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)

Participant Flow:   Overall Study
    Technosphere® Insulin (Asthma)   Usual Care (Asthma)   Technosphere® Insulin (COPD)   Usual Care (COPD)
STARTED   9   8   9   8 
COMPLETED   0   1   0   1 
NOT COMPLETED   9   7   9   7 
Adverse Event                2                0                1                0 
Study Terminated by Sponsor                7                6                4                5 
Withdrawal by Subject                0                1                1                1 
Protocol Violation                0                0                2                0 
Physician Decision                0                0                1                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.
Subjects who received at least one dose of study medication

Reporting Groups
  Description
Technosphere® Insulin (Asthma) Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
Usual Care (Asthma) Usual and anti diabetic care in diabetic participants with Asthma.
Technosphere® Insulin (COPD) Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
Usual Care (COPD) Usual and anti diabetic care in diabetic participants with COPD.
Total Total of all reporting groups

Baseline Measures
   Technosphere® Insulin (Asthma)   Usual Care (Asthma)   Technosphere® Insulin (COPD)   Usual Care (COPD)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   9   8   34 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.00  (7.26)   49.75  (15.73)   67.44  (8.38)   68.88  (8.20)   64.03  (12.71) 
Gender 
[Units: Participants]
         
Female   6   4   2   1   13 
Male   3   4   7   7   21 


  Outcome Measures
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1.  Primary:   Change in Post-bronchodilator FEV1 From Baseline to Week 52   [ Time Frame: 52 Weeks ]

2.  Secondary:   Number of Participants With Asthma Exacerbation by Treatment Arm   [ Time Frame: Baseline to Week 52 ]

3.  Secondary:   Number of Participants With COPD Exacerbation by Treatment Arm   [ Time Frame: Baseline to Week 52 ]

4.  Secondary:   Change in HbA1C From Baseline to Week 52   [ Time Frame: Baseline, week 52 ]


  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
- Early termination of trial leading to small numbers of subjects analyzed


  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: Trial Transparency Team
Organization: Sanofi
e-mail: ContactUS@sanofi.com



Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00642616     History of Changes
Other Study ID Numbers: MKC-TI-134
Study First Received: March 21, 2008
Results First Received: November 23, 2015
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration