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Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309244
First Posted: March 31, 2006
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mannkind Corporation
Results First Submitted: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Diabetes Type 2
Interventions: Drug: Technosphere® Insulin Inhalation Powder
Drug: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

  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 subject enrolled Feb. 23, 2006 Multi-national trial conducted in US, Canada, Mexico, Brazil, Argentina, Chile, Spain, UK, Poland, Russia

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 randomization – 2064 Screened / 673 Eligible . 677 subjects were randomized. ( 4 ineligible subjects were randomized in error) 1391 screen failures.

23 Subjects randomized but never dosed.


Reporting Groups
  Description
TI + Insulin Glargine Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
BPR 70/30 70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.

Participant Flow:   Overall Study
    TI + Insulin Glargine   BPR 70/30
STARTED   334   343 
COMPLETED   216   246 
NOT COMPLETED   118   97 
Adverse Event                29                12 
Lost to Follow-up                6                22 
Physician Decision                5                8 
Protocol Violation                6                3 
Withdrawal by Subject                50                32 
Various                7                7 
Randomized but not dosed                11                12 
Death                4                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 (23 Subjects randomized but never dosed are not included).

Reporting Groups
  Description
TI + Insulin Glargine Technosphere® Insulin Inhalation Powder + Insulin glargine
BPR 70/30 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Total Total of all reporting groups

Baseline Measures
   TI + Insulin Glargine   BPR 70/30   Total 
Overall Participants Analyzed 
[Units: Participants]
 323   331   654 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.9  (10.68)   55.9  (9.91)   55.9  (10.29) 
Gender 
[Units: Participants]
     
Female   160   185   345 
Male   163   146   309 
Fasting Plasma Glucose (FPG) [1] 
[Units: Milligrams per deciliter]
Mean (Standard Deviation)
 171.8  (68.53)   176.2  (67.15)   174  (67.82) 
[1] TI + Insulin glargine arm,302 subjects BPR 70/30 arm, 316 subjects
HbA1c [1] 
[Units: Percentage]
Mean (Standard Deviation)
 8.7  (1.14)   8.7  (1.10)   8.7  (1.12) 
[1] Glycosylated Hemoglobin
Weight [1] 
[Units: Kilogram]
Mean (Standard Deviation)
 88.1  (17.33)   85.7  (18.07)   86.9  (17.74) 
[1] Weight in kg TI + Insulin glargine arm, 322 subjects BPR 70/30 arm, 331 subjects


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c to Week 52   [ Time Frame: Baseline to Week 52 ]

2.  Secondary:   Change From Baseline in Weight to Week 52   [ Time Frame: Baseline to Week 52 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose to Week 52   [ Time Frame: Baseline to Week 52 ]

4.  Secondary:   Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%   [ Time Frame: Week 52 ]

5.  Secondary:   Incidence of Total Hypoglycemia   [ Time Frame: 52 Weeks ]

6.  Secondary:   Incidence of Severe Hypoglycemia   [ Time Frame: 52 Weeks ]

7.  Secondary:   Total Hypoglycemia Event Rate   [ Time Frame: 52 Weeks ]

8.  Secondary:   Severe Hypoglycemia Event Rate   [ Time Frame: 52 Weeks ]


  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: NCT00309244     History of Changes
Other Study ID Numbers: MKC-TI-102
First Submitted: March 27, 2006
First Posted: March 31, 2006
Results First Submitted: July 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014