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
NCT ID: NCT00309244
Last Updated: 2014-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
677 participants
INTERVENTIONAL
2006-02-28
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TI + Insulin glargine
Technosphere® Insulin Inhalation Powder + insulin glargine
Technosphere® Insulin Inhalation Powder
Inhalation, 15U/30U
BPR 70/30
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
70% 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
Interventions
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Technosphere® Insulin Inhalation Powder
Inhalation, 15U/30U
70% 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Mannkind Corporation
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Southern Arizona VA Healthcare System
Tucson, Arizona, United States
Tucson Clinical Research
Tucson, Arizona, United States
International Clinical Research Network
Chula Vista, California, United States
Saad Hijazi MD Inc
Fresno, California, United States
Valley Research
Fresno, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
South Bay Clinical Research
Inglewood, California, United States
Southern California Endocrine Center
Pasadena, California, United States
Coastal Biomedical Research Inc
Santa Monica, California, United States
Diabetes Research Center
Tustin, California, United States
University of Miami Diabetes Research Institute
Miami, Florida, United States
International Research Associates LLC
Miami, Florida, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, United States
North Atlanta Endocrinology & Diabetes PC
Lawrenceville, Georgia, United States
Atlanta Center for Clinical Research
Roswell, Georgia, United States
John H Stoger Jr Hospital of Cook County
Chicago, Illinois, United States
Clintell Inc
Skokie, Illinois, United States
Clintell Inc (Ellyin)
Skokie, Illinois, United States
Medical Research of Louisiana
Metairie, Louisiana, United States
Joslin Diabetes Center University of Maryland Medicine
Baltimore, Maryland, United States
James A Dicke MDPA
Towson, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Michigan Institute of Medicine
Livonia, Michigan, United States
KMED Research
Saint Clair Shores, Michigan, United States
Radiant Research Inc (Minneapolis)
Edina, Minnesota, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Center for Urologic Clinical Trials University of Minnesota
Minneapolis, Minnesota, United States
Amin Radparvar's Private Practice
City of Saint Peters, Missouri, United States
MedEx Healthcare Research Inc
St Louis, Missouri, United States
Billings Clinic Research Division
Billings, Montana, United States
Montana Health Research Institute
Billings, Montana, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
University of New Mexico HCS
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States
Univeristy of Physicians Group Endocrine Division
Staten Island, New York, United States
Sensenbrenner Primary Care
Charlotte, North Carolina, United States
East Carolina University (Tanenberg)
Greenville, North Carolina, United States
Physician's East PA
Greenville, North Carolina, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Health Partners - Center of Clinical Research
Dayton, Ohio, United States
Cleveland Clinic Health System
East Cleveland, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
Oregon Medical Group Clinical Resesarch
Eugene, Oregon, United States
Lane Medical Research Group
Eugene, Oregon, United States
Portland Diabetes & Endocrinology Center
Portland, Oregon, United States
New Hope Research of Oregon
Portland, Oregon, United States
Covance CRU Inc.
Portland, Oregon, United States
Pennsylvania Research Institute
Bensalem, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Southeastern Research Associates Inc
Taylors, South Carolina, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
Memphis Internal Medicine PLLC
Memphis, Tennessee, United States
The Endocrine Clinic
Memphis, Tennessee, United States
Israel Hartman MD
Arlington, Texas, United States
South Arlington Primary Care Assoc PA
Arlington, Texas, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Radiant Research Dallas-North
Dallas, Texas, United States
Baylor Endocrine Center
Dallas, Texas, United States
Galenos Research
Dallas, Texas, United States
Spuhler Medical Associates
Friendswood, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Quality Assurance Research Center Inc
San Antonio, Texas, United States
Covenant Clinic Research
San Antonio, Texas, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States
SAM Clinical Research Center
San Antonio, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Sentara Medical Group
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Larry D Stonesifer MD Inc PS
Federal Way, Washington, United States
Rainier Clinical Research Center Inc
Renton, Washington, United States
Cedar Research
Tacoma, Washington, United States
Liberty Research Center
Tacoma, Washington, United States
Hospital Interzonal de Agudos Pedro Fiorito
Avellaneda, Buenos Aires, Argentina
CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas
San Miguel de Tucumán, Tucumán Province, Argentina
FUNDAPRES/CIMel
Buenos Aires, , Argentina
Centro Endocrinologic Tiempo
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Cons Asoc de Endocrinologia
Buenos Aires, , Argentina
Centro Medico Dra De Salvo
Buenos Aires, , Argentina
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CPClin-Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Universidade Estabual de Maringa
Maringa Parana, , Brazil
Nucleo de Medicina Integrada
Mogi das Cruzes, , Brazil
Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
Rio de Janeiro, , Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
Rio de Janeiro, , Brazil
Hospital Guilherme Alvaro
Santos, , Brazil
Hospital do Rim e Hipertensao
São Paulo, , Brazil
Instituto da Saude e Bem Estar da Mulher
São Paulo, , Brazil
Blumenau Servicos Medicos S/C Ltda
São Paulo, , Brazil
Centro de Pesquisa Clinica e Medicina Avancada
São Paulo, , Brazil
Keele Medical Place
Downsview, Ontario, Canada
Quest Clinical Trials
Markham, Ontario, Canada
Lifestyle Metabolism Center
Oakville, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Lifestyle Metabolism Center
Thornhill, Ontario, Canada
Lifestyle Metabolism Center
Toronto, Ontario, Canada
Hospital del Salvador
Santiago, Santiago Metropolitan, Chile
Hospital Padre Alberto Hurtado
Santiago, Santiago Metropolitan, Chile
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, , Chile
Hospital San Borja ArriaranUniversidad de Chile
Santiago, , Chile
Instituto Mexicano de Investigacion
Mexico City, Durango, Mexico
Hospital OCA
Monterrey, Nuevo Leon, MX, Mexico
Hospital Universitario Dr Jose E Gonzalez
Monterrey, Nuevo León, Mexico
Hospital Santa Engracia-CIMA
Garza García, , Mexico
Centro de Estudios en Diabetes
Mexico City, , Mexico
Cifbiotec
Mexico City, , Mexico
Oddzial Chorob Wewnetrznych
Bialystock, POL, Poland
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, POL, Poland
Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
Krakow, POL, Poland
Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, POL, Poland
Instytut Centrum Zdrowia (009) Matki Polki
Lodz, POL, Poland
Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
Pruszków, POL, Poland
NZOZ Diabetologiczna Poradnia Specjalistyczna
Warsaw, , Poland
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, Russia
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, Russia
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, Russia
Moscow City Clinical Hospital # 13
Moscow, RUS, Russia
SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
Moscow, RUS, Russia
SI Internal Affairs of Moscow- Clinical Hospital
Moscow, RUS, Russia
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, Russia
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
Saint Petersburg, RUS, Russia
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, Russia
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, Russia
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, Russia
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, Russia
MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
Yaroslavl, RUS, Russia
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, Russia
NI Central Clinical Hospital of RAS
Moscow, , Russia
City Clinical Hospital # 61
Moscow, , Russia
Complejo Hospitalario Nuestra Senora de Valme
Seville, Andalusia, Spain
Hospital de Mataro
Mataró, Barcelona, Spain
Hospital del Mar (Cano)
Barcelona, , Spain
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitario de la Princessa
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
Sabadell, , Spain
Complejo Hospitalario Virgen del Rocio
Seville, , Spain
Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
Seville, , Spain
Birchwood Surgery
Letchworth Garden City, Herts, United Kingdom
Lister Hospital
Stevenage, Herts, United Kingdom
Guy's & St Thomas Hospital
London, , United Kingdom
Yaxley Group Practice
Peterborough, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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MKC-TI-102
Identifier Type: -
Identifier Source: org_study_id
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