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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

31 de agosto de 2018 actualizado por: Pfizer

A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

413

Fase

  • Fase 4

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
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85051
        • Pfizer Investigational Site
      • Tucson, Arizona, Estados Unidos, 85712
        • Pfizer Investigational Site
    • California
      • Concord, California, Estados Unidos, 94520
        • Pfizer Investigational Site
      • Encino, California, Estados Unidos, 91436
        • Pfizer Investigational Site
      • Fresno, California, Estados Unidos, 93720
        • Pfizer Investigational Site
      • Fullerton, California, Estados Unidos, 92835
        • Pfizer Investigational Site
      • Long Beach, California, Estados Unidos, 90806
        • Pfizer Investigational Site
      • Mission Viejo, California, Estados Unidos, 92691
        • Pfizer Investigational Site
      • Pasadena, California, Estados Unidos, 91105
        • Pfizer Investigational Site
      • San Diego, California, Estados Unidos, 92120
        • Pfizer Investigational Site
      • San Diego, California, Estados Unidos, 92128
        • Pfizer Investigational Site
      • San Luis Obispo, California, Estados Unidos, 93401
        • Pfizer Investigational Site
      • Spring Valley, California, Estados Unidos, 91978
        • Pfizer Investigational Site
      • Stockton, California, Estados Unidos, 95204
        • Pfizer Investigational Site
      • Walnut Creek, California, Estados Unidos, 94598
        • Pfizer Investigational Site
      • West Hills, California, Estados Unidos, 91307
        • Pfizer Investigational Site
    • Colorado
      • Golden, Colorado, Estados Unidos, 80401
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, Estados Unidos, 06708
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • Pfizer Investigational Site
    • Florida
      • Chiefland, Florida, Estados Unidos, 32626
        • Pfizer Investigational Site
      • Clearwater, Florida, Estados Unidos, 33765
        • Pfizer Investigational Site
      • Hollywood, Florida, Estados Unidos, 33023
        • Pfizer Investigational Site
      • Kissimmee, Florida, Estados Unidos, 34741
        • Pfizer Investigational Site
      • Miami, Florida, Estados Unidos, 33156
        • Pfizer Investigational Site
      • Ocala, Florida, Estados Unidos, 34471
        • Pfizer Investigational Site
      • Saint Cloud, Florida, Estados Unidos, 34769
        • Pfizer Investigational Site
      • Winter Park, Florida, Estados Unidos, 32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, Estados Unidos, 30045
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, Estados Unidos, 30045-3388
        • Pfizer Investigational Site
      • Woodstock, Georgia, Estados Unidos, 30189
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • Pfizer Investigational Site
      • Hayden Lake, Idaho, Estados Unidos, 83835
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46254
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, Estados Unidos, 66211
        • Pfizer Investigational Site
      • Topeka, Kansas, Estados Unidos, 66606
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, Estados Unidos, 40213
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Pfizer Investigational Site
    • Massachusetts
      • Haverhill, Massachusetts, Estados Unidos, 01830-6141
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65807
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89104
        • Pfizer Investigational Site
    • New York
      • Staten Island, New York, Estados Unidos, 10301
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28209-3734
        • Pfizer Investigational Site
      • Statesville, North Carolina, Estados Unidos, 28625
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, Estados Unidos, 45429
        • Pfizer Investigational Site
      • Maumee, Ohio, Estados Unidos, 43537-9402
        • Pfizer Investigational Site
      • Toledo, Ohio, Estados Unidos, 43606
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73103
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, Estados Unidos, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Melrose Park, Pennsylvania, Estados Unidos, 19027
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29615
        • Pfizer Investigational Site
      • Greer, South Carolina, Estados Unidos, 29651
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Pfizer Investigational Site
    • Tennessee
      • Milan, Tennessee, Estados Unidos, 38358
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, Estados Unidos, 76014-2010
        • Pfizer Investigational Site
      • Beaumont, Texas, Estados Unidos, 77701
        • Pfizer Investigational Site
      • Dallas, Texas, Estados Unidos, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, Estados Unidos, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Estados Unidos, 75246
        • Pfizer Investigational Site
      • El Paso, Texas, Estados Unidos, 79935
        • Pfizer Investigational Site
      • Houston, Texas, Estados Unidos, 77008
        • Pfizer Investigational Site
      • Houston, Texas, Estados Unidos, 77083
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78229-3900
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, Estados Unidos, 05201-5018
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23249
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, Estados Unidos, 98003
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Pfizer Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Pfizer Investigational Site

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

30 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • Screening HbA1c > 7.0%
  • Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria:

Smoking within last 6 months PFTs outside of range

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Droga: Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Experimental: Exubera
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Droga: Inhaled Insulin (Exubera)
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Periodo de tiempo: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Periodo de tiempo: Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
Periodo de tiempo: Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
Periodo de tiempo: Week 26
Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.
Week 26
Change From Baseline in Fasting Plasma Glucose at Week 26
Periodo de tiempo: Baseline, Week 26
Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
Periodo de tiempo: Baseline, Week 26
Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
Periodo de tiempo: Baseline, Week 26
Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Lipids at Week 26
Periodo de tiempo: Baseline, Week 26
Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
Periodo de tiempo: Baseline, Week 26
CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
Periodo de tiempo: Baseline, Week 26
CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
Periodo de tiempo: Baseline, Week 26
24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
Periodo de tiempo: Baseline, Week 26
SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Number of Subjects With Hypoglycemic Events
Periodo de tiempo: Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Number of Total Hypoglycemic Events
Periodo de tiempo: Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.
Months 1 to 7
Number of Total Subject Months of Treatment
Periodo de tiempo: Months 1 to 7
Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Crude Hypoglycemic Event Rate
Periodo de tiempo: Months 1 to 7
crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Number of Nocturnal Hypoglycemic Events
Periodo de tiempo: Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.
Months 1 to 7
Change From Baseline in Body Weight at Week 26
Periodo de tiempo: Baseline, Week 26
Body weight value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Body Mass Index (BMI) at Week 26
Periodo de tiempo: Baseline, Week 26
BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire
Periodo de tiempo: Baseline, Week 26
Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.
Baseline, Week 26

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Periodo de tiempo: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Colaboradores e Investigadores

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

Patrocinador

Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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 marzo de 2007

Finalización primaria (Actual)

1 de agosto de 2008

Finalización del estudio (Actual)

1 de agosto de 2008

Fechas de registro del estudio

Enviado por primera vez

3 de enero de 2007

Primero enviado que cumplió con los criterios de control de calidad

4 de enero de 2007

Publicado por primera vez (Estimar)

5 de enero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2018

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

31 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A2171095

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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