A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00662857
First received: April 16, 2008
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus: Type 1
Interventions: Drug: Technosphere® Insulin Inhalation Powder
Drug: Technosphere Insulin® Inhalation Powder
Drug: RAA Population

  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
This was a single site with first subject screened 24 Apr 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects assigned at Visit 2 to either: 2 15 U cartridges (TI Inhalation Powder A) or 1 30 U cartridge (TI Inhalation Powder B). At Visit 3 each subject was crossed over to the other treatment group. At Visit 4 subjects received a single sc injection of 10 IU of insulin lispro to 1 of 3 possible injection sites: arm, leg, or abdomen.

Reporting Groups
  Description
TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure

Participant Flow for 5 periods

Period 1:   TI Dosing Period 1 (1 Day)
    TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro     TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro  
STARTED     13     16  
COMPLETED     13     16  
NOT COMPLETED     0     0  

Period 2:   Washout 1 (3 - 14 Days)
    TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro     TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro  
STARTED     13     16  
COMPLETED     13     14  
NOT COMPLETED     0     2  
Physician Decision                 0                 1  
Withdrawal by Subject                 0                 1  

Period 3:   TI Dosing Period 2 (1 Day)
    TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro     TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro  
STARTED     13     14  
COMPLETED     13     14  
NOT COMPLETED     0     0  

Period 4:   Washout 2 (3 - 14 Days)
    TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro     TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro  
STARTED     13     14  
COMPLETED     12     14  
NOT COMPLETED     1     0  
Cannot Use Clamp Data                 1                 0  

Period 5:   Lispro Dosing Period (1 Day)
    TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro     TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro  
STARTED     12     14  
COMPLETED     12     14  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Safety Population Any subject that received at least one treatment with TI inhalation powder

Baseline Measures
    Safety Population  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean ± Standard Deviation
  37.4  ± 12.71  
Gender  
[units: participants]
 
Female     10  
Male     19  
Body mass index (BMI)  
[units: kg/m squared]
Mean ± Standard Deviation
  26.61  ± 2.772  



  Outcome Measures
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1.  Primary:   Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360   [ Time Frame: 0 to 360 minutes post-dose ]

2.  Primary:   Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.   [ Time Frame: 0 to 360 minutes post-dose ]

3.  Primary:   Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax   [ Time Frame: 0 to 360 minutes post-dose ]

4.  Primary:   Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro   [ Time Frame: 0 to 360 minutes post-dose ]


  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
No text entered.


  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


No publications provided


Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00662857     History of Changes
Other Study ID Numbers: MKC-TI-116
Study First Received: April 16, 2008
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration