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Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

21 de octubre de 2014 actualizado por: Mannkind Corporation

A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

18

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Santa Barbara, California, Estados Unidos, 93105
        • Sansum Medical Research Institute

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Clinical diagnoses of type 1 or type 2 diabetes mellitus
  • Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and < or = 10.0%.
  • Body mass index (BMI) of < or = 40 kg/m2
  • Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dL
  • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
  • For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment

Exclusion Criteria:

  • History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
  • Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
  • Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
  • Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
  • Exposure to any investigational product(s) in the past 12 weeks
  • For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: TI Inhalation Powder (original protocol)
Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits.
Droga: TI Inhalation Powder (original protocol)
Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
Otro: TI Inhalation Powder and Humalog (Amendment 1)
Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal between visits.
Droga: TI Inhalation Powder and Humalog (Amendment 1)
Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes

AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.

AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.

TIme 0 corrected AUC (0-240) = AUC - AOC
0 to 240 minutes
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes

AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.

AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.

TIme 0 corrected AUC (0-240) = AUC - AOC
0 to 240 minutes
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes

AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.

AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.

TIme 0 corrected AUC (0-240) = AUC - AOC
0 to 240 minutes
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes

AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.

AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.

TIme 0 corrected AUC (0-240) = AUC - AOC
0 to 240 minutes
Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
0 to 240 minutes
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
0 to 240 minutes
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
0 to 240 minutes
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
0 to 240 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes
Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
0 to 240 minutes
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Periodo de tiempo: 0 to 240 minutes
Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast
0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
0 to 240 minutes
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Periodo de tiempo: 0 to 240 minutes
Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
0 to 240 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mannkind Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2008

Finalización primaria (Actual)

1 de febrero de 2011

Finalización del estudio (Actual)

1 de mayo de 2011

Fechas de registro del estudio

Enviado por primera vez

3 de septiembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2008

Publicado por primera vez (Estimar)

4 de septiembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de octubre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

21 de octubre de 2014

Última verificación

1 de octubre de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MKC-TI-119

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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