A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized,... | EligiMed

A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00332488Tipo: INTERVENTIONALInicio: 1 de dic de 2004

Traducción no disponible, mostrando original

Resumen

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for \>or= to 6 months
Stable regimen of metformin for \> or = to 1000mg/day or maximum tolerated dose) and a secretagogue \< or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
HbA1c \>or= to 7.5% and \< or= to 11.0%
BMI \< or = to 40kg/m2.
FEV1\> or = to 70%, Total Lung capacity and \> or =80% DLco \> or= to 70%

Criterios de exclusión

Treatment with any type of anti-diabetic therapy, other than metformin \& secretagogues within the preceding 12 weeks
Serum creatinine \> 1.4mg/dL in female subjects and \>1.5mg/dL in male subjects
History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Intervenciones

drug

Technosphere Insulin

Inhalation, 15U/30U, prandial

drug

Metformin & Secretagogues

Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

drug

Technosphere Insulin & Metformin

Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

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

Cons Asoc de Endocrinologia

Buenos Aires, Argentina

CIMeL

Buenos Aires, Argentina

Patrocinadores

PrincipalMannkind Corporation

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