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Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

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ClinicalTrials.gov Identifier: NCT00700622
Recruitment Status : Terminated (Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler))
First Posted : June 18, 2008
Results First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes, Type 1
Interventions Drug: Technosphere Insulin
Drug: Insulin glargine
Drug: Insulin lispro
Enrollment 130
Recruitment Details The FPFV was May 30, 2008. Multinational trial conducted in the US and Brazil.
Pre-assignment Details 2 week screening period prior to randomization – 276 Screened / 138 Eligible. 130 subjects were randomized; 138 screen failures and 8 discontinued prior to randomization.
Arm/Group Title TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) Humalog (insulin lispro) in combination with Lantus (insulin glargine)
Period Title: Overall Study
Started 65 65
Completed 52 60
Not Completed 13 5
Reason Not Completed
Adverse Event             4             0
Lost to Follow-up             0             1
Physician Decision             2             1
Protocol Violation             0             1
Withdrawal by Subject             4             1
Other             3             1
Arm/Group Title TI + Insulin Glargine Insulin Lispro + Insulin Glargine Total
Hide Arm/Group Description Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) Humalog (insulin lispro) in combination with Lantus (insulin glargine) Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 130 participants
38.6  (11.82) 39.4  (11.46) 39.0  (11.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
25
  38.5%
32
  49.2%
57
  43.8%
Male
40
  61.5%
33
  50.8%
73
  56.2%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 65 participants 65 participants 130 participants
74.49  (13.270) 74.18  (13.894) 74.3  (13.53)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 65 participants 65 participants 130 participants
172.22  (9.238) 169.61  (9.807) 170.9  (9.579)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants 65 participants 130 participants
25.07  (3.744) 25.63  (3.141) 25.3  (3.454)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 65 participants 65 participants 130 participants
7.76  (0.550) 7.62  (0.602) 7.69  (0.579)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 65 participants 65 participants 130 participants
86.26  (10.445) 87.31  (10.669) 86.78  (10.530)
Fasting Blood Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 65 participants 65 participants 130 participants
178.06  (76.916) 176.20  (67.268) 177.15  (72.084)
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Caucasian 56 59 115
Black 3 0 3
Hispanic 5 5 10
Other 1 1 2
1.Primary Outcome
Title Change From Baseline in HbA1c to Week 16
Hide Description Change from Baseline in glycosylated hemoglobin at Week 16
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat with Available Data at Week 16
Arm/Group Title TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
Humalog (insulin lispro) in combination with Lantus (insulin glargine)
Overall Number of Participants Analyzed 52 58
Least Squares Mean (Standard Error)
Unit of Measure: percentage of total hemoglobin
-0.10  (0.087) -0.03  (0.082)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.31 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.119
Estimation Comments [Not Specified]
Time Frame SAEs: From first dose to 30d post last dose AEs: From first dose to 30d post last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) Humalog (insulin lispro) in combination with Lantus (insulin glargine)
All-Cause Mortality
TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/65 (1.54%)   3/65 (4.62%) 
Injury, poisoning and procedural complications     
Delayed recovery from anesthesia  1  0/65 (0.00%)  1/65 (1.54%) 
Intentional overdose  1  0/65 (0.00%)  1/65 (1.54%) 
Metabolism and nutrition disorders     
Hypoglycemia  1  1/65 (1.54%)  2/65 (3.08%) 
Hypoglycemic seizure  1  0/65 (0.00%)  1/65 (1.54%) 
Psychiatric disorders     
Suicide attempt  1  0/65 (0.00%)  1/65 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TI + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%)
Total   42/65 (64.62%)   34/65 (52.31%) 
Endocrine disorders     
Hypoglycaemia  1  21/65 (32.31%)  23/65 (35.38%) 
General disorders     
Chest discomfort  1  4/65 (6.15%)  0/65 (0.00%) 
Infections and infestations     
Sinusitis  1  5/65 (7.69%)  2/65 (3.08%) 
Upper respiratory infection  1  5/65 (7.69%)  6/65 (9.23%) 
Influenza  1  3/65 (4.62%)  11/65 (16.92%) 
Nasopharyngitis  1  3/65 (4.62%)  4/65 (6.15%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  29/65 (44.62%)  0/65 (0.00%) 
Pharyngolaryngeal pain  1  4/65 (6.15%)  2/65 (3.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
- Early termination of trial leading to small numbers of subjects analyzed.
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.
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
Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00700622     History of Changes
Other Study ID Numbers: MKC-TI-117
First Submitted: June 16, 2008
First Posted: June 18, 2008
Results First Submitted: July 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014