This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
20 juli 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
413
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85051
- Pfizer Investigational Site
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Tucson, Arizona, Förenta staterna, 85712
- Pfizer Investigational Site
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California
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Concord, California, Förenta staterna, 94520
- Pfizer Investigational Site
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Encino, California, Förenta staterna, 91436
- Pfizer Investigational Site
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Fresno, California, Förenta staterna, 93720
- Pfizer Investigational Site
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Fullerton, California, Förenta staterna, 92835
- Pfizer Investigational Site
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Long Beach, California, Förenta staterna, 90806
- Pfizer Investigational Site
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Mission Viejo, California, Förenta staterna, 92691
- Pfizer Investigational Site
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Pasadena, California, Förenta staterna, 91105
- Pfizer Investigational Site
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San Diego, California, Förenta staterna, 92120
- Pfizer Investigational Site
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San Diego, California, Förenta staterna, 92128
- Pfizer Investigational Site
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San Luis Obispo, California, Förenta staterna, 93401
- Pfizer Investigational Site
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Spring Valley, California, Förenta staterna, 91978
- Pfizer Investigational Site
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Stockton, California, Förenta staterna, 95204
- Pfizer Investigational Site
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Walnut Creek, California, Förenta staterna, 94598
- Pfizer Investigational Site
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West Hills, California, Förenta staterna, 91307
- Pfizer Investigational Site
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Colorado
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Golden, Colorado, Förenta staterna, 80401
- Pfizer Investigational Site
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Connecticut
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Waterbury, Connecticut, Förenta staterna, 06708
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Förenta staterna, 19713
- Pfizer Investigational Site
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Florida
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Chiefland, Florida, Förenta staterna, 32626
- Pfizer Investigational Site
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Clearwater, Florida, Förenta staterna, 33765
- Pfizer Investigational Site
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Hollywood, Florida, Förenta staterna, 33023
- Pfizer Investigational Site
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Kissimmee, Florida, Förenta staterna, 34741
- Pfizer Investigational Site
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Miami, Florida, Förenta staterna, 33156
- Pfizer Investigational Site
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Ocala, Florida, Förenta staterna, 34471
- Pfizer Investigational Site
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Saint Cloud, Florida, Förenta staterna, 34769
- Pfizer Investigational Site
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Winter Park, Florida, Förenta staterna, 32789
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Pfizer Investigational Site
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Lawrenceville, Georgia, Förenta staterna, 30045
- Pfizer Investigational Site
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Lawrenceville, Georgia, Förenta staterna, 30045-3388
- Pfizer Investigational Site
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Woodstock, Georgia, Förenta staterna, 30189
- Pfizer Investigational Site
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Idaho
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Boise, Idaho, Förenta staterna, 83702
- Pfizer Investigational Site
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Hayden Lake, Idaho, Förenta staterna, 83835
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46254
- Pfizer Investigational Site
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Kansas
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Overland Park, Kansas, Förenta staterna, 66211
- Pfizer Investigational Site
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Topeka, Kansas, Förenta staterna, 66606
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
- Pfizer Investigational Site
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Louisville, Kentucky, Förenta staterna, 40213
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Pfizer Investigational Site
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New Orleans, Louisiana, Förenta staterna, 70121
- Pfizer Investigational Site
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Massachusetts
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Haverhill, Massachusetts, Förenta staterna, 01830-6141
- Pfizer Investigational Site
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Missouri
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Springfield, Missouri, Förenta staterna, 65807
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68131
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89104
- Pfizer Investigational Site
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New York
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Staten Island, New York, Förenta staterna, 10301
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28209-3734
- Pfizer Investigational Site
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Statesville, North Carolina, Förenta staterna, 28625
- Pfizer Investigational Site
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Pfizer Investigational Site
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Ohio
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Kettering, Ohio, Förenta staterna, 45429
- Pfizer Investigational Site
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Maumee, Ohio, Förenta staterna, 43537-9402
- Pfizer Investigational Site
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Toledo, Ohio, Förenta staterna, 43606
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73103
- Pfizer Investigational Site
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Oregon
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Medford, Oregon, Förenta staterna, 97504
- Pfizer Investigational Site
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Pennsylvania
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Melrose Park, Pennsylvania, Förenta staterna, 19027
- Pfizer Investigational Site
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- Pfizer Investigational Site
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Greer, South Carolina, Förenta staterna, 29651
- Pfizer Investigational Site
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Spartanburg, South Carolina, Förenta staterna, 29303
- Pfizer Investigational Site
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Tennessee
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Milan, Tennessee, Förenta staterna, 38358
- Pfizer Investigational Site
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Texas
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Arlington, Texas, Förenta staterna, 76014-2010
- Pfizer Investigational Site
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Beaumont, Texas, Förenta staterna, 77701
- Pfizer Investigational Site
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Dallas, Texas, Förenta staterna, 75231
- Pfizer Investigational Site
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Dallas, Texas, Förenta staterna, 75230
- Pfizer Investigational Site
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Dallas, Texas, Förenta staterna, 75246
- Pfizer Investigational Site
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El Paso, Texas, Förenta staterna, 79935
- Pfizer Investigational Site
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Houston, Texas, Förenta staterna, 77008
- Pfizer Investigational Site
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Houston, Texas, Förenta staterna, 77083
- Pfizer Investigational Site
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San Antonio, Texas, Förenta staterna, 78229
- Pfizer Investigational Site
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San Antonio, Texas, Förenta staterna, 78229-3900
- Pfizer Investigational Site
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Vermont
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Bennington, Vermont, Förenta staterna, 05201-5018
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Förenta staterna, 23249
- Pfizer Investigational Site
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Washington
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Federal Way, Washington, Förenta staterna, 98003
- Pfizer Investigational Site
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Wisconsin
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Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Pfizer Investigational Site
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Carolina, Puerto Rico, 00983
- Pfizer Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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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.
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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.
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Tidsram: Baseline, Week 26
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HbA1c lab value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Tidsram: Week 26
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Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.
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Week 26
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Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
Tidsram: Week 26
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Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.
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Week 26
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Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
Tidsram: Week 26
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Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.
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Week 26
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Change From Baseline in Fasting Plasma Glucose at Week 26
Tidsram: Baseline, Week 26
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Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
Tidsram: Baseline, Week 26
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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.
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Baseline, Week 26
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Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
Tidsram: Baseline, Week 26
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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.
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Baseline, Week 26
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Change From Baseline in Lipids at Week 26
Tidsram: Baseline, Week 26
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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.
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Baseline, Week 26
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Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
Tidsram: Baseline, Week 26
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CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
Tidsram: Baseline, Week 26
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CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
Tidsram: Baseline, Week 26
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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.
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Baseline, Week 26
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Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
Tidsram: Baseline, Week 26
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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.
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Baseline, Week 26
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Number of Subjects With Hypoglycemic Events
Tidsram: Months 1 to 7
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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.
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Months 1 to 7
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Number of Total Hypoglycemic Events
Tidsram: Months 1 to 7
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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.
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Months 1 to 7
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Number of Total Subject Months of Treatment
Tidsram: Months 1 to 7
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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.
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Months 1 to 7
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Crude Hypoglycemic Event Rate
Tidsram: Months 1 to 7
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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.
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Months 1 to 7
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Number of Nocturnal Hypoglycemic Events
Tidsram: Months 1 to 7
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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.
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Months 1 to 7
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Change From Baseline in Body Weight at Week 26
Tidsram: Baseline, Week 26
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Body weight value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Change From Baseline in Body Mass Index (BMI) at Week 26
Tidsram: Baseline, Week 26
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BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Tidsram: Baseline, Week 26
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HbA1c lab value: Change = value at Week 26 minus value at Baseline.
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Baseline, Week 26
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2007
Primärt slutförande (Faktisk)
1 augusti 2008
Avslutad studie (Faktisk)
1 augusti 2008
Studieregistreringsdatum
Först inskickad
3 januari 2007
Först inskickad som uppfyllde QC-kriterierna
4 januari 2007
Första postat (Beräknad)
5 januari 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2025
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Peptidhormoner
- Peptider
- Aminosyror, peptider och proteiner
- Insulin, långverkande
- Insuliner
- Bukspottkörtelhormoner
- Insulin Glargine
- Exubera
Andra studie-ID-nummer
- A2171095
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .