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CompletedNCT01445951Updated Oct 22, 2014Results posted

Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

A Phase 3 interventional study of Technosphere® Insulin with MedTone C Inhaler and Technosphere ®Insulin with Gen2 Inhaler in Type 1 Diabetes Mellitus, sponsored by Mannkind Corporation. Completed at 90 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-22.

Sponsored by Mannkind Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
518
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Read the detailed description

Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 518 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Mannkind Corporation is the lead sponsor of 57 studies on the registry; 3 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Browse Mannkind Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women = 18 years of age
  • Clinical diagnosis of type 1 diabetes mellitus for at least 12 months
  • Body mass index (BMI) = 38 kg/m2
  • Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently \< 220 mg/dL:
  • HbA1c = 7.5% and = 10.0%
  • Fasting C-peptide = 0.30 pmol/mL
  • Subject willingness to not use CGM during the entire course of the trial
  • Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months
  • Negative urine cotinine test, defined as = 100 ng/mL
  • Lung function tests: • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Total daily insulin dose = 2 IU/kg/day. History of insulin pump use within 3 months of Screening or use of continuous glucose monitoring within 6 weeks of Screening
  • History of inhaled insulin use in the previous 6 months
  • Two or more unexplained severe hypoglycemic episodes within 3 months of Screening or an episode of severe hypoglycemia between Visit 1 and Visit 2. Unexplained refers to episodes of severe hypoglycemia that are not related to a dosing error, lack of or a change in meal size, or related to additional/unanticipated exercise
  • Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 2
  • Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the study, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure
  • History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements.
  • History of COPD, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions
  • Any clinically significant radiological findings on screening chest x-ray
  • Active respiratory infection within 30 days before Screening (subject may return after 30 days from resolution for rescreening)
  • Major organ system diseases, including: ? Seizure disorder; systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine; cancer (other than excised cutaneous basal cell carcinoma) or any history of lung neoplasms
  • Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity; use of medications for weight loss (eg, sibutramine, orlistat) within 12 weeks of Screening; treatment with amiodarone within 12 weeks of Screening
  • Clinically significant abnormalities on screening laboratory evaluation or chest x-ray
  • Severe complications of diabetes, in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; nontraumatic amputations due to gangrene; or vascular claudication
  • Women who are pregnant, lactating, or planning to become pregnant during the clinical study period; women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this study includes amenorrhea f
  • Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the PI, would make the subject an unsuitable candidate for participation in the study
  • Exposure to any investigational medications or devices within the previous 30 days before study entry
  • Unable to read or write, or unlikely to comprehend and follow the study protocol procedures; lack of compliance with medication or procedures that, in the PI's opinion, may affect the study data or subject safety and that precludes the subject from participation in the study; or any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical study or could limit the validity of the informed consent or impair the subject'
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
518 participants (actual)

Study arms

  • Experimental
    Technosphere® Insulin with MedTone C Inhaler

    Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry

    Drug: Technosphere® Insulin with MedTone C Inhaler

  • Active comparator
    Aspart Group

    Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry

    Drug: Insulin Aspart in combination with a basal insulin

  • Experimental
    Technosphere ® Insulin-Gen2 Group

    Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry

    Drug: Technosphere ®Insulin with Gen2 Inhaler

Interventions

  • DrugTechnosphere® Insulin with MedTone C Inhaler

    Inhalation Powder and injectable insulin

  • DrugTechnosphere ®Insulin with Gen2 Inhaler

    Inhalation Powder and injectable insulin

  • DrugInsulin Aspart in combination with a basal insulin

    Injectable insulin

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 24 in HbA1c

    Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24

    Time frame: Baseline to Week 24

Secondary outcomes

  1. FEV1 Change From Baseline to Week 24

    Forced Expiratory Volume in 1 second - change from baseline to week 24

    Time frame: Baseline to Week 24

  2. FPG Change From Baseline to Week 24

    Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)

    Time frame: Baseline to Week 24

  3. Mean 7-point Glucose Baseline Values

    Mean 7-point glucose at baseline

    Time frame: Baseline

  4. Mean 7-point Glucose Week 24 Values

    Time frame: Week 24

  5. Change in Body Weight From Baseline to Week 24

    Change in body weight from Baseline to Week 24

    Time frame: Baseline to Week 24

  6. Proportion of Responders Achieving HbA1c <= 7.0%

    Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 7.0%

    Time frame: Week 24

Other outcomes

  1. Incidence of Total Hypoglycemia

    Hypoglycemia, defined as blood glucose \<= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.

    Time frame: Baseline to Week 24

  2. Incidence of Severe Hypoglycemia

    Severe Hypoglycemia defined as: Requiring 3rd party assistance.

    Time frame: Baseline to Week 24

  3. Total Hypoglycemia Event Rate

    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

    Time frame: Baseline to Week 24

  4. Severe Hypoglycemia Event Rate

    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

    Time frame: Baseline to Week 24

07

Results

Posted Oct 22, 2014

Participant flow

First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil.

Participant flow — Overall Study
MilestoneTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Started174174170
Completed130138151
Not completed443619
Withdrew: Adverse event1690
Withdrew: Protocol violation222
Withdrew: Withdrawal by subject21168
Withdrew: Physician decision310
Withdrew: Lost to follow-up124
Withdrew: Pregnancy014
Withdrew: Death001
Withdrew: Non-compliance with study drug120
Withdrew: Non-compliance with protocol010
Withdrew: Sponsor decision - subject travel010
Withdrew: Cough010

Outcome measures

PrimaryChange From Baseline to Week 24 in HbA1c

Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · Percent of hemoglobin
Change From Baseline to Week 24 in HbA1c
Percent of hemoglobinTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Change From Baseline to Week 24 in HbA1c-0.21 ± 0.062-0.29 ± 0.061-0.40 ± 0.060
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Mean difference (net): 0.19 · 95% CI 0.02 to 0.36
SecondaryFEV1 Change From Baseline to Week 24

Forced Expiratory Volume in 1 second - change from baseline to week 24

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · Liters
FEV1 Change From Baseline to Week 24
LitersTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
FEV1 Change From Baseline to Week 24-0.07 ± 0.012-0.08 ± 0.012-0.04 ± 0.011
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Technosphere Insulin-MedTone + Basal Insulin · Mean difference (net): 0.01 · 95% CI -0.02 to 0.04Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)
SecondaryFPG Change From Baseline to Week 24

Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · mg/dL
FPG Change From Baseline to Week 24
mg/dLTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
FPG Change From Baseline to Week 24-25.27 ± 7.627.15 ± 7.5310.15 ± 7.40
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Mean difference (net): -35.42 · 95% CI -56.25 to -14.59MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)
SecondaryMean 7-point Glucose Baseline Values

Mean 7-point glucose at baseline

Time frame:
Baseline
Reported as:
Mean · mg/dL
Mean 7-point Glucose Baseline Values
mg/dLTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Before breakfast154.1 ± 38.85151.8 ± 40.32147.0 ± 39.09
After breakfast173.3 ± 48.77173.5 ± 48.36162.6 ± 49.50
Before lunch158.0 ± 47.39156.6 ± 42.91142.3 ± 37.86
After lunch169.5 ± 52.25169.7 ± 49.23157.6 ± 48.08
Before dinner169.9 ± 47.12168.1 ± 45.24154.0 ± 46.53
After dinner176.2 ± 51.55177.0 ± 53.17158.5 ± 47.64
Bedtime178.3 ± 51.38175.1 ± 43.99164.4 ± 49.97
SecondaryMean 7-point Glucose Week 24 Values
Time frame:
Week 24
Reported as:
Mean · mg/dL
Mean 7-point Glucose Week 24 Values
mg/dLTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Before breakfast148.2 ± 40.64147.9 ± 43.17155.3 ± 48.44
After breakfast169.7 ± 67.53164.1 ± 60.97163.0 ± 58.00
Before lunch168.2 ± 56.93165.9 ± 59.95149.1 ± 50.58
After lunch173.7 ± 57.09163.1 ± 50.92158.2 ± 50.04
Before dinner177.8 ± 59.96177.3 ± 56.71156.8 ± 48.30
After dinner180.8 ± 63.50168.2 ± 60.77157.8 ± 52.62
Bedtime185.2 ± 62.36185.6 ± 54.96175.4 ± 57.37
SecondaryChange in Body Weight From Baseline to Week 24

Change in body weight from Baseline to Week 24

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · kg
Change in Body Weight From Baseline to Week 24
kgTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Change in Body Weight From Baseline to Week 24-0.39 ± 0.438-0.19 ± 0.4280.93 ± 0.441
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · ANCOVA · p = 0.0102 · Mean difference (final values): -1.32 · 95% CI -2.33 to -0.31ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment
  • Technosphere Insulin-Gen2 + Basal Insulin · t-test, 2 sided · p = 0.4955
  • Technosphere Insulin-MedTone + Basal Insulin · t-test, 2 sided · p = 0.6807
  • Insulin Aspart + Basal Insulin · t-test, 2 sided · p = 0.0079
Other pre-specifiedIncidence of Total Hypoglycemia

Hypoglycemia, defined as blood glucose \<= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.

Time frame:
Baseline to Week 24
Reported as:
Number · percentage of participants
Incidence of Total Hypoglycemia
percentage of participantsTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Incidence of Total Hypoglycemia96.096.099.4
Other pre-specifiedIncidence of Severe Hypoglycemia

Severe Hypoglycemia defined as: Requiring 3rd party assistance.

Time frame:
Baseline to Week 24
Reported as:
Number · percentage of participants
Incidence of Severe Hypoglycemia
percentage of participantsTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Incidence of Severe Hypoglycemia18.421.429.2
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Regression, Logistic · p = 0.0156 · Odds ratio (or): 0.5328 · 95% CI 0.3198 to 0.8877Logistic model with affects for Region, Basal insulin stratum, and Treatment
Other pre-specifiedTotal Hypoglycemia Event Rate

Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

Time frame:
Baseline to Week 24
Reported as:
Number · Events/Subject-Month
Total Hypoglycemia Event Rate
Events/Subject-MonthTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Total Hypoglycemia Event Rate9.8010.3013.97
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Negative Binomial Regression · p = <0.0001Model: Region + Basal Insulin Stratum + Treatment + Exposure Time
Other pre-specifiedSevere Hypoglycemia Event Rate

Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

Time frame:
Baseline to Week 24
Reported as:
Number · Events/Subject-Month
Severe Hypoglycemia Event Rate
Events/Subject-MonthTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Severe Hypoglycemia Event Rate8.059.9914.45
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Negative Binomial Regression · p = 0.1022Model: Region + Basal Insulin Stratum + Treatment + Exposure Time
SecondaryProportion of Responders Achieving HbA1c <= 7.0%

Efficacy as measured in proportion of subjects achieving HbA1c \< or = to 7.0%

Time frame:
Week 24
Reported as:
Number · percentage of participants
Proportion of Responders Achieving HbA1c <= 7.0%
percentage of participantsTechnosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal Insulin
Proportion of Responders Achieving HbA1c <= 7.0%18.321.730.7
Statistical analysis
  • Technosphere Insulin-Gen2 + Basal Insulin vs Insulin Aspart + Basal Insulin · Regression, Logistic · p = 0.0158 · Odds ratio (or): 0.449 · 95% CI 0.23 to 0.86Gen2 in the numerator, Aspart in the denominator

Adverse events

Collected over Baseline to Week 24. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Technosphere ® Insulin-Gen2 Group—5/174 (2.9%)81/174 (46.6%)
Technosphere® Insulin With MedTone C Inhaler—9/173 (5.2%)74/173 (42.8%)
Aspart Group—7/171 (4.1%)50/171 (29.2%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTechnosphere ® Insulin-Gen2 GroupTechnosphere® Insulin With MedTone C InhalerAspart Group
Hypoglycaemic UnconsciousnessNervous system disorders1/1744/1732/171
HypoglycaemiaMetabolism and nutrition disorders1/1742/1731/171
DrowningGeneral disorders0/1740/1731/171
AppendicitisInfections and infestations0/1740/1731/171
Spinal OsteoarthritisMusculoskeletal and connective tissue disorders0/1740/1731/171
Hypoglycaemic SeizureNervous system disorders1/1741/1731/171
Mental Status ChangesPsychiatric disorders0/1740/1731/171
Chest DiscomfortGeneral disorders0/1741/1730/171
Cervical PolypReproductive system and breast disorders0/1741/1730/171
Cytomegalovirus InfectionInfections and infestations1/1740/1730/171
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTechnosphere ® Insulin-Gen2 GroupTechnosphere® Insulin With MedTone C InhalerAspart Group
CoughRespiratory, thoracic and mediastinal disorders55/17439/1734/171
Upper Respiratory Tract InfectionInfections and infestations14/17416/17312/171
NasopharyngitisInfections and infestations5/17413/17312/171
InfluenzaInfections and infestations2/1749/1733/171
HeadacheNervous system disorders7/1745/1734/171
DyspnoeaRespiratory, thoracic and mediastinal disorders7/1740/1730/171
NauseaGastrointestinal disorders1/1745/1736/171
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders3/1746/1733/171
Urinary Tract InfectionInfections and infestations1/1746/1733/171
BronchitisInfections and infestations6/1741/1734/171

Baseline characteristics

Full analysis set

Age, Customized
Age, Customized(participants)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
18-30 years564846150
31-49 years938488265
50-64 years18332879
>= 65 years79824
Sex: Female, Male
Sex: Female, Male(Participants)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
Female979496287
Male778074231
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
Hispanic or Latino17221857
Not Hispanic or Latino157152152461
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
American Indian or Alaska Native0000
Asian1102
Native Hawaiian or Other Pacific Islander1001
Black or African American85316
White164167166497
More than one race0000
Unknown or Not Reported0112
Region of Enrollment
Region of Enrollment(participants)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
United States716967207
Brazil14151342
Ukraine443838120
Russian Federation455252149
Duration of Diabetes
Duration of Diabetes(years)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
Mean16.0 (1.1 to 57.3)17.7 (1.1 to 49.5)16.7 (1.0 to 42.2)16.8 (1.0 to 57.3)
Weight
Weight(kg)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
Mean75.7 (41.7 to 129.4)76.8 (47.6 to 124.0)72.6 (46.6 to 120.2)75.1 (41.7 to 129.4)
BMI
BMI(kg/m^2)Technosphere Insulin-Gen2 + Basal InsulinTechnosphere Insulin-MedTone + Basal InsulinInsulin Aspart + Basal InsulinTotal
Mean26.0 (16.6 to 38.6)26.2 (18.1 to 36.4)25.4 (17.4 to 37.2)25.9 (16.6 to 38.6)

2 further baseline measures are reported on the registry.

08

Study locations

90 sites
  • Burlingame, California 94010, United States
  • Escondido, California 92026, United States
  • Huntington Beach, California 92648, United States
  • La Jolla, California 92037, United States
  • La Mesa, California 91942, United States
  • Long Beach, California 90806, United States
  • Los Angeles, California 90017, United States
  • Los Angeles, California 90036, United States
  • Los Gatos, California 95032, United States
  • San Mateo, California 94401, United States
  • Santa Barbara, California 93105, United States
  • Tustin, California 92780, United States
  • Aurora, Colorado 80045, United States
  • Hialeah, Florida 33012, United States
  • Hollywood, Florida 33021, United States
  • Miami, Florida 33156, United States
  • Miami, Florida 33173, United States
  • New Port Richey, Florida 34652, United States
  • Palm Harbor, Florida 34652, United States
  • West Palm Beach, Florida 33401, United States
  • Atlanta, Georgia 30308, United States
  • Atlanta, Georgia 30318, United States
  • Dunwoody, Georgia 30338, United States
  • Lawrenceville, Georgia 30045, United States
  • Roswell, Georgia 30076, United States
  • Chicago, Illinois 60602, United States
  • Vincennes, Indiana 47591, United States
  • Des Moines, Iowa 50314, United States
  • Baton Rouge, Louisiana 70808, United States
  • Metairie, Louisiana 70006, United States
  • New Orleans, Louisiana 70112, United States
  • Edina, Minnesota 55435, United States
  • City of Saint Peters, Missouri 63376, United States
  • Jefferson City, Missouri 65109, United States
  • St Louis, Missouri 63110, United States
  • Billings, Montana 59101, United States
  • Omaha, Nebraska 68114, United States
  • Omaha, Nebraska 68131, United States
  • Paramus, New Jersey 07652, United States
  • Albuquerque, New Mexico 87131, United States
  • Flushing, New York 11365, United States
  • New Hyde Park, New York 11042, United States
  • New York, New York 10016, United States
  • Asheville, North Carolina 28803, United States
  • Greenville, North Carolina 27834, United States
  • Morehead City, North Carolina 28557, United States
  • Portland, Oregon 97239, United States
  • Greer, South Carolina 29651, United States
  • Bartlett, Tennessee 38133, United States
  • Arlington, Texas 76014, United States
  • Dallas, Texas 75230, United States
  • Dallas, Texas 75246, United States
  • Houston, Texas 77095, United States
  • San Antonio, Texas 78229, United States
  • Murray, Utah 84123, United States
  • Federal Way, Washington 98003, United States
  • Renton, Washington 98057, United States
  • Wenatchee, Washington 98801, United States
  • Porto Alegre, Rio Grande do Sul 90035-170, Brazil
  • São Paulo, São Paulo 01244-030, Brazil
  • Saint Petersburg, Russia 191186, Russia
  • Saint Petersburg, Russia 193312, Russia
  • Kemerovo, RUS 650066, Russia
  • Moscow, RUS 105120, Russia
  • Moscow, RUS 109240, Russia
  • Moscow, RUS 117036, Russia
  • Moscow, RUS 117593, Russia
  • Moscow, RUS 119048, Russia
  • Moscow, RUS 119435, Russia
  • Moscow, RUS 125299, Russia
  • Moscow, RUS 125315, Russia
  • Petrozavodsk, RUS 185019, Russia
  • Saint Petersburg, RUS 192148, Russia
  • Saint Petersburg, RUS 194044, Russia
  • Saint Petersburg, RUS 194291, Russia
  • Saint Petersburg, RUS 194354, Russia
  • Saint Petersburg, RUS 195257, Russia
  • Saint Petersburg, RUS 198013, Russia
  • Smolensk, RUS 214018, Russia
  • Yaroslavl, RUS 150003, Russia
  • Yaroslavl, RUS 150062, Russia
  • Dnipropetrovsk, UKR 49023, Ukraine
  • Donetsk, UKR 83114, Ukraine
  • Kharkiv, UKR 61070, Ukraine
  • Kiev, UKR 04053, Ukraine
  • Kiev, UKR 04114, Ukraine
  • Kyiv, UKR 02175, Ukraine
  • Odesa, UKR 65039, Ukraine
  • Odesa, UKR 65114, Ukraine
  • Vinnytsia, UKR 21010, Ukraine
09

References and documents

Publications

  • Seaquist ER, Blonde L, McGill JB, Heller SR, Kendall DM, Bumpass JB, Pompilio FM, Grant ML. Hypoglycaemia is reduced with use of inhaled Technosphere(R) Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020 May;37(5):752-759. doi: 10.1111/dme.14202. Epub 2019 Dec 19. PubMed 31811662 ↗
  • Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15. PubMed 26180109 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01445951
Lead sponsor
Mannkind Corporation
Responsible party
Sponsor
First posted
Oct 4, 2011
Start date
Sep 2011
Primary completion
May 2013
Completion
Jun 2013
Results posted
Oct 22, 2014
Last update
Oct 22, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 1 →

Other studies from this sponsor

Mannkind Corporation →

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