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

20. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

413

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2007

Primær fullføring (Faktiske)

1. august 2008

Studiet fullført (Faktiske)

1. august 2008

Datoer for studieregistrering

Først innsendt

3. januar 2007

Først innsendt som oppfylte QC-kriteriene

4. januar 2007

Først lagt ut (Antatt)

5. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A2171095

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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