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

31. august 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

413

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Tidsramme: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Tidsramme: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

3. januar 2007

Først indsendt, der opfyldte QC-kriterier

4. januar 2007

Først opslået (Skøn)

5. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2171095

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Insulin glargine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner