A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

TerminadoFase 3ClinicalTrials.gov

ID: NCT00332826Tipo: INTERVENTIONALInicio: 1 de jun de 2006Fin estimado: 1 de oct de 2007

Traducción no disponible, mostrando original

Resumen

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
Subjects must exhibit \<30% variability in PEF measurements during the 2 week run in period.
Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
Body mass index (BMI) \< 40kg/m2
HbA1c \>6.0% to \<11.5%

Criterios de exclusión

Severe complications of diabetes in the opinion of the investigator
Seizure disorder
Significant cardiovascular dysfunction and/or history within 3 months of screening
Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure \>110 mm HG at screening despite pharmacologic therapy.
Clinical nephrotic syndrome or renal dysfunction or disease
Total daily insulin requirement of \>1.4 U/kg body weight
Clinical diagnosis of Step 4 asthma
Use of \>6 puffs/day of fast acting bronchodilator
Currently using an insulin delivery pump
Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
Two or more severe hypoglycemic episodes within the past 6 months.
Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
Current use of systemic steroids
Subjects who currently smoke tobacco or who have smoked within the past 6 months
Urine cotinine test of \> 100ng/ml
Current drug or alcohol abuse
Clinically significant abnormalities on screening laboratory evaluation
Cancer within the past 5 years or any history of lung neoplasms
History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
Active infection or history of severe infection with 30 days of screening.
Anemia
History of anaphylaxis and/or angioneurotic edema
Diagnosis of chronic obstructive pulmonary disease (COPE)
Previous exposure to any inhaled insulin product

Intervenciones

drug

Technosphere Insulin

Ubicaciones

DIM (Clinica Privada)

Buenos Aires, Argentina

Ins De Inv Cardiovascular La Plata

La Plata, Argentina

Patrocinadores

PrincipalMannkind Corporation

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