A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

CompletadoFase 3ClinicalTrials.gov

ID: NCT00308308Tipo: INTERVENTIONALInicio: 1 de feb de 2006Fin estimado: 1 de ago de 2008

Endocrinología

Traducción no disponible, mostrando original

Resumen

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Clinical diagnosis of type 1 diabetes for at least 1 year
Nonsmokers for prior 6 months
BMI less than or equal to 35kg/m2
HbA1c \> or = 7% and \< or = 11%
Serum creatinine \< or = 1.8 mg/dL in female subjects and \< or = 2.0 mg/dL in male subjects
FEV1 \> or = 70% of predicted, DLco \> or = 70% , TLC \> or = 80% predicted
Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
Urine cotinine \< or = 100 ng/mL

Criterios de exclusión

History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
Evidence of severe complications of diabetes
Aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal

Intervenciones

drug

Technosphere Insulin

Inhalation, 15U/30U

drug

Active comparator

sc injectable insulin

Ubicaciones

Hospital Interzonal de Agudos Pedro Fiorito

Avellaneda, Buenos Aires, Argentina

Centro Endocrinologic Tiempo

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Durand /Buenos Aires

Buenos Aires, Argentina

Hospital Gral De Agudos Dr. Teodoro Alvarez

Buenos Aires, Argentina

Cons Asoc de Endocrinologia

Buenos Aires, Argentina

Centro Medico Dra De Salvo

Buenos Aires, Argentina

CIMeL

Buenos Aires, Argentina

Patrocinadores

PrincipalMannkind Corporation

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