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CompletedNCT00309244Updated Oct 16, 2014Results posted

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

A Phase 3 interventional study of Technosphere® Insulin Inhalation Powder and 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) in Diabetes Type 2, sponsored by Mannkind Corporation. Completed at 151 sites in 10 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-16.

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

Phase
Phase 3
Study type
Interventional
Enrollment
677
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

02

Conditions studied

  • Diabetes Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 677 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Mannkind Corporation is the lead sponsor of 55 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.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men or women ≥ 18 and ≤ 80 years old
  • Clinical diagnosis of type 2 diabetes mellitus
  • HbA1c > 7.0% and ≤ 11.0%
  • BMI ≤ 40 kg/m2
  • Negative smoking status and urine cotinine test
  • Written informed consent
  • Receiving sc insulin 2-3 times daily administered as any of the following 3 regimens: self-mix regimen, pre-mix regimen, or long-acting analogue and regular or rapid-acting insulin analogue not to exceed 3 daily injections. Subjects may also have received oral antidiabetic agents including metformin or thiazolidinediones.
  • No dose adjustments for insulin and oral antidiabetic agents within the preceding 6 weeks.
  • FEV1 ≥ 70% of NHANES III predicted; TLC) ≥ 80% of predicted (Intermountain Thoracic Society); DLCO uncorrected ≥ 70% of predicted

Exclusion criteria

Exclusion Criteria:

  • Total daily dose of insulin ≥1.4 IU/kg body weight
  • Treatment with any sulfonylureas and/or meglitinides and/or alpha-glucosidase inhibitors within the preceding 8 weeks
  • Treatment with pramlintide acetate (Symlin®), and/or any incretins (e.g., exenatide [Byetta®]) within the preceding 8 weeks
  • Unstable diabetes mellitus control, defined as 2 or more episodes of severe hypoglycemia (requiring third party intervention) and/or any hospitalization or emergency room visit due to poor diabetic control or hyperglycemia requiring hospitalization within the preceding 6 months
  • Exposure to an inhaled insulin at any time, treatment with an investigational drug within the preceding 3 months, and/or current participation in another clinical trial
  • Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the investigational drug or to drugs of similar chemical structures
  • History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST)and/or alanine aminotransferase (ALT) ≥ 3 x Upper Limit of Normal (ULN)(Includes active hepatitis A, positive hepatitis B and/or hepatitis C serology)
  • Serum creatinine > 1.8 mg/dL in women and > 2.0 mg/dL in men History of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings
  • Congestive heart disease graded as class III or class IV according to New York Heart Association criteria and subjects currently being treated pharmacologically for ventricular dysrhythmias using amiodarone
  • History of myocardial infarction, cardiac surgery, coronary angioplasty, and/or stroke within the preceding 3 months
  • Symptomatic coronary artery disease, including crescendo angina, unstable angina, and/or unstable or symptomatic cardiac arrhythmias
  • Poorly controlled arterial hypertension despite pharmacologic treatment, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 110 mm Hg at screening
  • History of malignancy within the preceding 5 years (other than excised basal cell carcinoma of the skin), any history of lung neoplasm, and/or subjects with current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
  • History of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), or positive human immunodeficiency virus (HIV) serology
  • Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
  • Visit 1/Screening (Week -3), but prior to Visit 1 PFTs and before Visit 3/Baseline (Week 0), subject will be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin and urine β-HCG (for women of childbearing potential age only) will be required
  • Women who are pregnant, lactating or planning to become pregnant
  • Women of childbearing potential (defined as pre-menopausal and not surgically sterilized or postmenopausal for less than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous and/or transdermal contraceptives; condoms and diaphragms with a spermicide, or intrauterine devices
  • Current drug and/or alcohol abuse
  • Subjects who in the opinion of the Investigator will be unable to comply with the requirements of the protocol
  • Severe complications of diabetes mellitus, in the opinion of the Investigator, including: symptomatic autonomic neuropathy, disabling peripheral neuropathy, active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene;and/or vascular claudication
  • Any other concurrent medical or major psychiatric condition which, in the opinion of the Investigator, makes the subject unsuitable for the clinical trial, or could limit the validity of the ICF and/or impair the subject's ability to participate in the trial
  • Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) acceptability and repeatability criteria.
05

Study design

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

Study arms

  • Experimental
    TI + Insulin glargine

    Technosphere® Insulin Inhalation Powder + insulin glargine

    Drug: Technosphere® Insulin Inhalation Powder

  • Active comparator
    BPR 70/30

    70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

    Drug: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

Interventions

  • DrugTechnosphere® Insulin Inhalation Powder

    Inhalation, 15U/30U

  • Drug70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

    BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

06

What researchers measure

Primary outcomes

  1. Change From Baseline in HbA1c to Week 52

    Time frame: Baseline to Week 52

Secondary outcomes

  1. Change From Baseline in Weight to Week 52

    Time frame: Baseline to Week 52

  2. Change From Baseline in Fasting Plasma Glucose to Week 52

    Time frame: Baseline to Week 52

  3. Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%

    Time frame: Week 52

  4. Incidence of Total Hypoglycemia

    Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.

    Time frame: 52 Weeks

  5. Incidence of Severe Hypoglycemia

    Severe hypoglycemia occurs when all 3 of the following occur simultaneously: * Subject requires the assistance of another person; * Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); * Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, * Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

    Time frame: 52 Weeks

  6. Total Hypoglycemia Event Rate

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

    Time frame: 52 Weeks

  7. Severe Hypoglycemia Event Rate

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

    Time frame: 52 Weeks

07

Results

Posted Oct 16, 2014

Participant flow

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

Participant flow — Overall Study
MilestoneTI + Insulin GlargineBPR 70/30
Started334343
Completed216246
Not completed11897
Withdrew: Adverse event2912
Withdrew: Lost to follow-up622
Withdrew: Physician decision58
Withdrew: Protocol violation63
Withdrew: Withdrawal by subject5032
Withdrew: Various77
Withdrew: Randomized but not dosed1112
Withdrew: Death41

Outcome measures

PrimaryChange From Baseline in HbA1c to Week 52
Time frame:
Baseline to Week 52
Reported as:
Least squares mean · percent
Change From Baseline in HbA1c to Week 52
percentTI + Insulin GlargineBPR 70/30
Change From Baseline in HbA1c to Week 52-0.59 ± 0.063-0.71 ± 0.061
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · ANCOVA · Mean difference (final values): 0.12 · 95% CI -0.05 to 0.29
SecondaryChange From Baseline in Weight to Week 52
Time frame:
Baseline to Week 52
Reported as:
Least squares mean · kilogram
Change From Baseline in Weight to Week 52
kilogramTI + Insulin GlargineBPR 70/30
Change From Baseline in Weight to Week 520.9 ± 0.322.5 ± 0.29
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · ANCOVA · p = 0.0002 · Mean difference (net): -1.6 · 95% CI -2.4 to -0.7
SecondaryChange From Baseline in Fasting Plasma Glucose to Week 52
Time frame:
Baseline to Week 52
Reported as:
Least squares mean · milligrams per deciliter
Change From Baseline in Fasting Plasma Glucose to Week 52
milligrams per deciliterTI + Insulin GlargineBPR 70/30
Change From Baseline in Fasting Plasma Glucose to Week 52-35.7 ± 4.61-17.9 ± 4.21
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · ANCOVA · p = 0.0029 · Mean difference (net): -17.7 · 95% CI -29.3 to -6.1
SecondaryNumber of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
Time frame:
Week 52
Reported as:
Number · participants
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
participantsTI + Insulin GlargineBPR 70/30
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%4765
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · Regression, Logistic · p = 0.2793 · Odds ratio (or): 0.774 · 95% CI 0.486 to 1.231
SecondaryIncidence of Total Hypoglycemia

Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.

Time frame:
52 Weeks
Reported as:
Number · percentage of participants
Incidence of Total Hypoglycemia
percentage of participantsTI + Insulin GlargineBPR 70/30
Incidence of Total Hypoglycemia47.9968.58
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · Regression, Logistic · p = <0.001 · Odds ratio (or): 0.423 · 95% CI 0.307 to 0.581Model: Treatment + Site
SecondaryIncidence of Severe Hypoglycemia

Severe hypoglycemia occurs when all 3 of the following occur simultaneously: * Subject requires the assistance of another person; * Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); * Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, * Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

Time frame:
52 Weeks
Reported as:
Number · percentage of participants
Incidence of Severe Hypoglycemia
percentage of participantsTI + Insulin GlargineBPR 70/30
Incidence of Severe Hypoglycemia4.339.97
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · Regression, Logistic · p = 0.0066 · Odds ratio (or): 0.409 · 95% CI 0.215 to 0.780Model: Treatment + Site
SecondaryTotal Hypoglycemia Event Rate

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

Time frame:
52 Weeks
Reported as:
Number · Number of events/subject-month
Total Hypoglycemia Event Rate
Number of events/subject-monthTI + Insulin GlargineBPR 70/30
Total Hypoglycemia Event Rate0.410.61
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · Generalized Estimation Equation · p = 0.0027Based on Poisson distribution
SecondarySevere Hypoglycemia Event Rate

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

Time frame:
52 Weeks
Reported as:
Number · Number of events/100 subject-months
Severe Hypoglycemia Event Rate
Number of events/100 subject-monthsTI + Insulin GlargineBPR 70/30
Severe Hypoglycemia Event Rate0.732.20
Statistical analysis
  • TI + Insulin Glargine vs BPR 70/30 · Generalized Estimating Equation · p = 0.0591Based on Poission distribution

Adverse events

Collected over From first dose to 30 days after last dose. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TI + Insulin Glargine—37/323 (11.5%)225/323 (69.7%)
BPR 70/30—31/331 (9.4%)251/331 (75.8%)
Most frequent serious events
Showing 10 of 91
Most frequent serious events
EventTI + Insulin GlargineBPR 70/30
HypoglycaemiaMetabolism and nutrition disorders3/3236/331
Loss of consciousnessNervous system disorders1/3233/331
Atrial fibrillationCardiac disorders2/3231/331
Coronary artery diseaseCardiac disorders2/3230/331
DizzinessNervous system disorders2/3230/331
Angina pectorisCardiac disorders0/3232/331
Coronary artery insufficiencyCardiac disorders0/3232/331
CholecystitisHepatobiliary disorders0/3232/331
CholelithiasisHepatobiliary disorders0/3232/331
AppendicitisInfections and infestations0/3232/331
Most frequent other events
Most frequent other events
EventTI + Insulin GlargineBPR 70/30
HypoglycaemiaMetabolism and nutrition disorders155/323228/331
CoughRespiratory, thoracic and mediastinal disorders106/32320/331
Upper respiratory tract infectionInfections and infestations39/32324/331
NasopharyngitisInfections and infestations30/32328/331
Urinary tract infectionInfections and infestations10/32321/331
InfluenzaInfections and infestations18/32318/331
HeadacheNervous system disorders18/32312/331

Baseline characteristics

Safety population (23 Subjects randomized but never dosed are not included).

Age, Continuous
Age, Continuous(years)TI + Insulin GlargineBPR 70/30Total
Mean55.9 ± 10.6855.9 ± 9.9155.9 ± 10.29
Sex: Female, Male
Sex: Female, Male(Participants)TI + Insulin GlargineBPR 70/30Total
Female160185345
Male163146309
Fasting Plasma Glucose (FPG)
Fasting Plasma Glucose (FPG)(milligrams per deciliter)TI + Insulin GlargineBPR 70/30Total
Mean171.8 ± 68.53176.2 ± 67.15174 ± 67.82
HbA1c
HbA1c(percentage)TI + Insulin GlargineBPR 70/30Total
Mean8.7 ± 1.148.7 ± 1.108.7 ± 1.12
Weight
Weight(kilogram)TI + Insulin GlargineBPR 70/30Total
Mean88.1 ± 17.3385.7 ± 18.0786.9 ± 17.74
08

Study locations

151 sites
  • Coastal Clinical Research Inc
    Mobile, Alabama 36608, United States
  • Quality of Life Medical & Research Center
    Tucson, Arizona 85712, United States
  • Southern Arizona VA Healthcare System
    Tucson, Arizona 85723, United States
  • Tucson Clinical Research
    Tucson, Arizona 85741, United States
  • International Clinical Research Network
    Chula Vista, California 91911, United States
  • Saad Hijazi MD Inc
    Fresno, California 93710, United States
  • Valley Research
    Fresno, California 93720, United States
  • Diabetes/Lipid Management and Research Center
    Huntington Beach, California 92648, United States
  • South Bay Clinical Research
    Inglewood, California 90301, United States
  • Southern California Endocrine Center
    Pasadena, California 91105, United States
  • Coastal Biomedical Research Inc
    Santa Monica, California 90404, United States
  • Diabetes Research Center
    Tustin, California 92780, United States
  • University of Miami Diabetes Research Institute
    Miami, Florida 33136, United States
  • International Research Associates LLC
    Miami, Florida 33156, United States
  • Laureate Clinical Research Group
    Atlanta, Georgia 30308, United States
  • Atlanta Pharmaceutical Research Center
    Dunwoody, Georgia 30338, United States
  • North Atlanta Endocrinology & Diabetes PC
    Lawrenceville, Georgia 30045, United States
  • Atlanta Center for Clinical Research
    Roswell, Georgia 30075, United States
  • John H Stoger Jr Hospital of Cook County
    Chicago, Illinois 60612, United States
  • Clintell Inc
    Skokie, Illinois 60076, United States
  • Clintell Inc (Ellyin)
    Skokie, Illinois 60077, United States
  • Medical Research of Louisiana
    Metairie, Louisiana 70002, United States
  • Joslin Diabetes Center University of Maryland Medicine
    Baltimore, Maryland 21201, United States
  • James A Dicke MDPA
    Towson, Maryland 21204, United States
  • Wayne State University
    Detroit, Michigan 48201, United States
  • Michigan Institute of Medicine
    Livonia, Michigan 48152, United States
  • KMED Research
    St Clair Shores, Michigan 48081, United States
  • Radiant Research Inc (Minneapolis)
    Edina, Minnesota 55435, United States
  • International Diabetes Center
    Minneapolis, Minnesota 55416, United States
  • Center for Urologic Clinical Trials University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • MedEx Healthcare Research Inc
    St Louis, Missouri 63117, United States
  • Amin Radparvar's Private Practice
    St Peters, Missouri 63376, United States
  • Billings Clinic Research Division
    Billings, Montana 59101, United States
  • Montana Health Research Institute
    Billings, Montana 59102, United States
  • Creighton Diabetes Center
    Omaha, Nebraska 68131, United States
  • New Mexico Clinical Research & Osteoporosis Center
    Albuquerque, New Mexico 87106, United States
  • University of New Mexico HCS
    Albuquerque, New Mexico 87131, United States
  • Winthrop University Hospital
    Mineola, New York 11501, United States
  • North Shore Diabetes and Endocrine Associates
    New Hyde Park, New York 11042, United States
  • Univeristy of Physicians Group Endocrine Division
    Staten Island, New York 10301, United States
  • Sensenbrenner Primary Care
    Charlotte, North Carolina 28277, United States
  • East Carolina University (Tanenberg)
    Greenville, North Carolina 27834, United States
  • Physician's East PA
    Greenville, North Carolina 27834, United States
  • Valley Medical Primary Care
    Centerville, Ohio 45459, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Providence Health Partners - Center of Clinical Research
    Dayton, Ohio 45439, United States
  • Cleveland Clinic Health System
    East Cleveland, Ohio 44112, United States
  • Wells Institute for Health Awareness
    Kettering, Ohio 45429, United States
  • Oregon Medical Group Clinical Resesarch
    Eugene, Oregon 97401, United States
  • Lane Medical Research Group
    Eugene, Oregon 97404, United States
  • Portland Diabetes & Endocrinology Center
    Portland, Oregon 97210, United States
  • New Hope Research of Oregon
    Portland, Oregon 97219, United States
  • Covance CRU Inc.
    Portland, Oregon 97239, United States
  • Pennsylvania Research Institute
    Bensalem, Pennsylvania 19020, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Upstate Pharmaceutical Research
    Greenville, South Carolina 29615, United States
  • Southeastern Research Associates Inc
    Taylors, South Carolina 29687, United States
  • AM Diabetes and Endocrinology Center
    Bartlett, Tennessee 38133, United States
  • Memphis Internal Medicine PLLC
    Memphis, Tennessee 38119, United States
  • The Endocrine Clinic
    Memphis, Tennessee 38119, United States
  • Israel Hartman MD
    Arlington, Texas 76014, United States
  • South Arlington Primary Care Assoc PA
    Arlington, Texas 76017, United States
  • Dallas Diabetes & Endocrine Center
    Dallas, Texas 75230, United States
  • North Texas Endocrine Center
    Dallas, Texas 75231, United States
  • Radiant Research Dallas-North
    Dallas, Texas 75231, United States
  • Baylor Endocrine Center
    Dallas, Texas 75246, United States
  • Galenos Research
    Dallas, Texas 75251, United States
  • Spuhler Medical Associates
    Friendswood, Texas 77546, United States
  • Clinical Trial Network
    Houston, Texas 77074, United States
  • Quality Assurance Research Center Inc
    San Antonio, Texas 78205, United States
  • Covenant Clinic Research
    San Antonio, Texas 78229, United States
  • Diabetes & Glandular Disease Research Assoc PA
    San Antonio, Texas 78229, United States
  • SAM Clinical Research Center
    San Antonio, Texas 78229, United States
  • Salt Lake Research
    Salt Lake City, Utah 84107, United States
  • Sentara Medical Group
    Norfolk, Virginia 23502, United States
  • Clinical Research Associates of Tidewater
    Norfolk, Virginia 23507, United States
  • Larry D Stonesifer MD Inc PS
    Federal Way, Washington 98003, United States
  • Rainier Clinical Research Center Inc
    Renton, Washington 98055, United States
  • Cedar Research
    Tacoma, Washington 98405, United States
  • Liberty Research Center
    Tacoma, Washington 98405, United States
  • Hospital Interzonal de Agudos Pedro Fiorito
    Avellaneda, Buenos Aires B1870ARG, Argentina
  • CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas
    San Miguel de Tucuman, Tucuman 4000, Argentina
  • FUNDAPRES/CIMel
    Buenos Aires, B1824KAJ, Argentina
  • Centro Endocrinologic Tiempo
    Buenos Aires, C1117ABH, Argentina
  • Hospital Italiano de Buenos Aires
    Buenos Aires, C1181ACH, Argentina
  • Cons Asoc de Endocrinologia
    Buenos Aires, C1425AGC, Argentina
  • Centro Medico Dra De Salvo
    Buenos Aires, C1426ABP, Argentina
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
  • Hospital Sao Lucas da PUCRS
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • Universidade Estabual de Maringa
    Maringa Parana, 87020-900, Brazil
  • Nucleo de Medicina Integrada
    Mogi das Cruzes, 08780-090, Brazil
  • Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
    Rio de Janeiro, 20211-340, Brazil
  • Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
    Rio de Janeiro, 22271-100, Brazil
  • Hospital Guilherme Alvaro
    Santos, 11045-904, Brazil
  • CPClin-Centro de Pesquisas Clinicas
    Sao Paulo, 01244-030, Brazil
  • Hospital do Rim e Hipertensao
    Sao Paulo, 04025-011, Brazil
  • Instituto da Saude e Bem Estar da Mulher
    Sao Paulo, 04062-003, Brazil
  • Blumenau Servicos Medicos S/C Ltda
    Sao Paulo, 05302-001, Brazil
  • Centro de Pesquisa Clinica e Medicina Avancada
    Sao Paulo, 05437-010, Brazil
  • Keele Medical Place
    Downsview, Ontario M3M 3E5, Canada

Showing the first 100 of 151 sites across 10 countries.

09

References and documents

Publications

  • Peyrot M, Rubin RR. Patient-reported outcomes in adults with type 2 diabetes using mealtime inhaled technosphere insulin and basal insulin versus premixed insulin. Diabetes Technol Ther. 2011 Dec;13(12):1201-6. doi: 10.1089/dia.2011.0037. Epub 2011 Oct 14. PubMed 21999640 ↗
  • Rosenstock J, Lorber DL, Gnudi L, Howard CP, Bilheimer DW, Chang PC, Petrucci RE, Boss AH, Richardson PC. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010 Jun 26;375(9733):2244-53. doi: 10.1016/S0140-6736(10)60632-0. PubMed 20609970 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00309244
Lead sponsor
Mannkind Corporation
Responsible party
Sponsor
First posted
Mar 31, 2006
Start date
Feb 2006
Primary completion
Aug 2008
Completion
Sep 2008
Results posted
Oct 16, 2014
Last update
Oct 16, 2014
View the source record on ClinicalTrials.gov ↗

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