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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

Information source: Mannkind Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Type 2

Intervention: Technosphere® Insulin Inhalation Powder (Drug); 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mannkind Corporation

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.

Clinical Details

Official title: A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Change From Baseline in HbA1c to Week 52

Secondary outcome:

Change From Baseline in Weight to Week 52

Change From Baseline in Fasting Plasma Glucose to Week 52

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

Incidence of Total Hypoglycemia

Incidence of Severe Hypoglycemia

Total Hypoglycemia Event Rate

Severe Hypoglycemia Event Rate

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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:

- 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.

Locations and Contacts

Centro Endocrinologic Tiempo, Buenos Aires C1117ABH, Argentina

Centro Medico Dra De Salvo, Buenos Aires C1426ABP, Argentina

Cons Asoc de Endocrinologia, Buenos Aires C1425AGC, Argentina

FUNDAPRES/CIMel, Buenos Aires B1824KAJ, Argentina

Hospital Italiano de Buenos Aires, Buenos Aires C1181ACH, Argentina

Universidade Estabual de Maringa, Maringa Parana 87020-900, Brazil

Nucleo de Medicina Integrada, Mogi das Cruzes 08780-090, Brazil

Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda, Rio de Janeiro 22271-100, Brazil

Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione, Rio de Janeiro 20211-340, Brazil

Hospital Guilherme Alvaro, Santos 11045-904, Brazil

Blumenau Servicos Medicos S/C Ltda, Sao Paulo 05302-001, Brazil

Centro de Pesquisa Clinica e Medicina Avancada, Sao Paulo 05437-010, 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

Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago, Chile

Hospital San Borja ArriaranUniversidad de Chile, Santiago, Chile

Hospital Santa Engracia-CIMA, Garza Garcia 66260, Mexico

Centro de Estudios en Diabetes, Mexico City 01120, Mexico

Cifbiotec, Mexico City CP14050, Mexico

NZOZ Diabetologiczna Poradnia Specjalistyczna, Warszawa 01-911, Poland

City Clinical Hospital # 61, Moscow 119 048, Russian Federation

NI Central Clinical Hospital of RAS, Moscow 117 593, Russian Federation

Centro Médico Teknon, Barcelona 08022, Spain

Hospital del Mar (Cano), Barcelona 08003, Spain

Hospital Ramon y Cajal, Madrid 28034, Spain

Hospital Universitario de la Princessa, Madrid 28006, Spain

Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia, Sabadell 08208, Spain

Complejo Hospitalario Virgen del Rocio, Sevilla 41013, Spain

Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion, Sevilla 41071, Spain

Guy's & St Thomas Hospital, London SE1 9RT, United Kingdom

Yaxley Group Practice, Peterborough PE7 3JL, United Kingdom

Coastal Clinical Research Inc, Mobile, Alabama 36608, United States

Complejo Hospitalario Nuestra Senora de Valme, Sevilla, Andalucia 41014, Spain

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

Hospital de Mataro, Mataro, Barcelona 08304, Spain

Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda, Buenos Aires B1870ARG, Argentina

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

Instituto Mexicano de Investigacion, Mexico City, Durango 06700, Mexico

International Research Associates LLC, Miami, Florida 33156, United States

University of Miami Diabetes Research Institute, Miami, Florida 33136, 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

Birchwood Surgery, Letchworth, Herts SG6 4UB, United Kingdom

Lister Hospital, Stevenage, Herts SG1 4AB, United Kingdom

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

Hospital OCA, Monterrey, Nuevo Leon, MX 64000, Mexico

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

Center for Urologic Clinical Trials University of Minnesota, Minneapolis, Minnesota 55455, United States

International Diabetes Center, Minneapolis, Minnesota 55416, 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

Hospital Universitario Dr Jose E Gonzalez, Monterrey, Nuevo Leon 64460, Mexico

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

Keele Medical Place, Downsview, Ontario M3M 3E5, Canada

Quest Clinical Trials, Markham, Ontario L6B 1A1, Canada

Lifestyle Metabolism Center, Oakville, Ontario L6H 3P1, Canada

Sarnia Institute of Clinical Research, Sarnia, Ontario N7T 4X3, Canada

Lifestyle Metabolism Center, Thornhill, Ontario L4J 8L7, Canada

Lifestyle Metabolism Center, Toronto, Ontario M4R 2G4, Canada

Lane Medical Research Group, Eugene, Oregon 97404, United States

Oregon Medical Group Clinical Resesarch, Eugene, Oregon 97401, United States

Covance CRU Inc., Portland, Oregon 97239, United States

New Hope Research of Oregon, Portland, Oregon 97219, United States

Portland Diabetes & Endocrinology Center, Portland, Oregon 97210, United States

Oddzial Chorob Wewnetrznych, Bialystock, POL 15-950, Poland

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok, POL 15-435, Poland

Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego, Krakow, POL 31 501, Poland

Instytut Centrum Zdrowia (009) Matki Polki, Lodz, POL 93-338, Poland

Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz, POL 90 153, Poland

Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii, Pruszkow, POL 05 800, Poland

Pennsylvania Research Institute, Bensalem, Pennsylvania 19020, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

NHI Kemerovo Regional Clinical Hospital, Kemerovo, RUS 650061, Russian Federation

Moscow City Clinical Hospital # 13, Moscow, RUS 115280, Russian Federation

NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70, Moscow, RUS 111399, Russian Federation

NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense, Moscow, RUS 105229, Russian Federation

RAAMS Endocrinology and Diabetology Department, Moscow, RUS 125315, Russian Federation

SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology, Moscow, RUS 119435, Russian Federation

SI Internal Affairs of Moscow- Clinical Hospital, Moscow, RUS 125299, Russian Federation

NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital, Smolensk, RUS 214018, Russian Federation

Central Medical Sanitary Unit #122, St Petersburg, RUS 194291, Russian Federation

Pavlov State Medical Univ of St Petersburg, St Petersburg, RUS 197022, Russian Federation

St Petersburg NHI City Polytclinic #77 City Diabetological Center #4, St Petersburg, RUS 193012, Russian Federation

MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant, Yaroslavl, RUS 150023, Russian Federation

MHI Clinical Hospital for Emergency Care na NV Soloviev, Yaroslavl, RUS 150003, Russian Federation

NHI Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS 150062, Russian Federation

Hospital del Salvador, Santiago, Region Metropolitana, Chile

Hospital Padre Alberto Hurtado, Santiago, Region Metropolitana, Chile

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

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

Baylor Endocrine Center, Dallas, Texas 75246, United States

Dallas Diabetes & Endocrine Center, Dallas, Texas 75230, United States

Galenos Research, Dallas, Texas 75251, United States

North Texas Endocrine Center, Dallas, Texas 75231, United States

Radiant Research Dallas-North, Dallas, Texas 75231, United States

Spuhler Medical Associates, Friendswood, Texas 77546, United States

Clinical Trial Network, Houston, Texas 77074, United States

Covenant Clinic Research, San Antonio, Texas 78229, United States

Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas 78229, United States

Quality Assurance Research Center Inc, San Antonio, Texas 78205, United States

SAM Clinical Research Center, San Antonio, Texas 78229, United States

CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas, San Miguel de Tucuman, Tucuman 4000, Argentina

Salt Lake Research, Salt Lake City, Utah 84107, United States

Clinical Research Associates of Tidewater, Norfolk, Virginia 23507, United States

Sentara Medical Group, Norfolk, Virginia 23502, 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

Additional Information

Starting date: February 2006
Last updated: October 9, 2014

Page last updated: August 23, 2015

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