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

31 agosto 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

413

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Lasso di tempo: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Lasso di tempo: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2007

Completamento primario (Effettivo)

1 agosto 2008

Completamento dello studio (Effettivo)

1 agosto 2008

Date di iscrizione allo studio

Primo inviato

3 gennaio 2007

Primo inviato che soddisfa i criteri di controllo qualità

4 gennaio 2007

Primo Inserito (Stima)

5 gennaio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A2171095

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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