Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
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ClinicalTrials.gov Identifier: NCT01445951 |
Recruitment Status :
Completed
First Posted : October 4, 2011
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
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Sponsor:
Mannkind Corporation
Information provided by (Responsible Party):
Mannkind Corporation
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Type 1 Diabetes Mellitus |
Interventions |
Drug: Technosphere® Insulin with MedTone C Inhaler Drug: Technosphere ®Insulin with Gen2 Inhaler Drug: Insulin Aspart in combination with a basal insulin |
Enrollment | 518 |
Participant Flow
Recruitment Details | First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil. |
Pre-assignment Details | 3 week Screening Period prior to run-in (basal insulin optimization period). 1401 Screened / 621 Eligible of which 614 entered the run-in period. 538 met randomization criteria at end of run-in of which 518 were randomized. |
Arm/Group Title | Technosphere Insulin-Gen2 + Basal Insulin | Technosphere Insulin-MedTone + Basal Insulin | Insulin Aspart + Basal Insulin |
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Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient | Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient | Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient |
Period Title: Overall Study | |||
Started | 174 | 174 | 170 |
Completed | 130 | 138 | 151 |
Not Completed | 44 | 36 | 19 |
Reason Not Completed | |||
Adverse Event | 16 | 9 | 0 |
Protocol Violation | 2 | 2 | 2 |
Withdrawal by Subject | 21 | 16 | 8 |
Physician Decision | 3 | 1 | 0 |
Lost to Follow-up | 1 | 2 | 4 |
Pregnancy | 0 | 1 | 4 |
Death | 0 | 0 | 1 |
Non-compliance with study drug | 1 | 2 | 0 |
Non-compliance with protocol | 0 | 1 | 0 |
Sponsor decision - subject travel | 0 | 1 | 0 |
Cough | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Technosphere Insulin-Gen2 + Basal Insulin | Technosphere Insulin-MedTone + Basal Insulin | Insulin Aspart + Basal Insulin | Total | |
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Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient | Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient | Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient | Total of all reporting groups | |
Overall Number of Baseline Participants | 174 | 174 | 170 | 518 | |
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Full analysis set
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants |
18-30 years | 56 | 48 | 46 | 150 | |
31-49 years | 93 | 84 | 88 | 265 | |
50-64 years | 18 | 33 | 28 | 79 | |
>= 65 years | 7 | 9 | 8 | 24 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
Female |
97 55.7%
|
94 54.0%
|
96 56.5%
|
287 55.4%
|
|
Male |
77 44.3%
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80 46.0%
|
74 43.5%
|
231 44.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
Hispanic or Latino |
17 9.8%
|
22 12.6%
|
18 10.6%
|
57 11.0%
|
|
Not Hispanic or Latino |
157 90.2%
|
152 87.4%
|
152 89.4%
|
461 89.0%
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 0.6%
|
1 0.6%
|
0 0.0%
|
2 0.4%
|
|
Native Hawaiian or Other Pacific Islander |
1 0.6%
|
0 0.0%
|
0 0.0%
|
1 0.2%
|
|
Black or African American |
8 4.6%
|
5 2.9%
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3 1.8%
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16 3.1%
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White |
164 94.3%
|
167 96.0%
|
166 97.6%
|
497 95.9%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
1 0.6%
|
1 0.6%
|
2 0.4%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants |
United States | 71 | 69 | 67 | 207 | |
Brazil | 14 | 15 | 13 | 42 | |
Ukraine | 44 | 38 | 38 | 120 | |
Russian Federation | 45 | 52 | 52 | 149 | |
Duration of Diabetes
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
16.0
(1.1 to 57.3)
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17.7
(1.1 to 49.5)
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16.7
(1.0 to 42.2)
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16.8
(1.0 to 57.3)
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Weight
Mean (Full Range) Unit of measure: Kg |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
75.7
(41.7 to 129.4)
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76.8
(47.6 to 124.0)
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72.6
(46.6 to 120.2)
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75.1
(41.7 to 129.4)
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BMI
Mean (Full Range) Unit of measure: Kg/m^2 |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
26.0
(16.6 to 38.6)
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26.2
(18.1 to 36.4)
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25.4
(17.4 to 37.2)
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25.9
(16.6 to 38.6)
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Fasting Plasma Glucose
Mean (Full Range) Unit of measure: mg/dL |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
155.0
(21.0 to 403.0)
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144.3
(43.0 to 358.0)
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151.2
(23.0 to 375.0)
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150.2
(21.0 to 403.0)
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HbA1c
Mean (Full Range) Unit of measure: Percent of hemoglobin |
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Number Analyzed | 174 participants | 174 participants | 170 participants | 518 participants | |
7.98
(6.20 to 10.60)
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8.00
(6.10 to 10.20)
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7.88
(5.80 to 10.10)
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7.95
(5.80 to 10.60)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | MannKind Corporation |
Phone: | 201-983-5000 |
EMail: | aboss@mannkindcorp.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT01445951 |
Other Study ID Numbers: |
MKC-TI-171 |
First Submitted: | September 30, 2011 |
First Posted: | October 4, 2011 |
Results First Submitted: | July 22, 2014 |
Results First Posted: | October 22, 2014 |
Last Update Posted: | October 22, 2014 |