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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Ubicaciones

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Technosphere® Insulin Inhalation Powder

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

Ubicaciones

Hospital Interzonal de Agudos Pedro Fiorito

CITDEEM - Centro de Investigacion y Tratamiento En Diabetes y Enfermedades Endocrino-Metabolicas

FUNDAPRES/CIMel

Centro Endocrinologic Tiempo

Hospital Italiano de Buenos Aires

Cons Asoc de Endocrinologia

Centro Medico Dra De Salvo

Patrocinadores