This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
20 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
413
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Carolina, Puerto Rico, 00983
- Pfizer Investigational Site
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85051
- Pfizer Investigational Site
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Tucson, Arizona, Verenigde Staten, 85712
- Pfizer Investigational Site
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California
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Concord, California, Verenigde Staten, 94520
- Pfizer Investigational Site
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Encino, California, Verenigde Staten, 91436
- Pfizer Investigational Site
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Fresno, California, Verenigde Staten, 93720
- Pfizer Investigational Site
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Fullerton, California, Verenigde Staten, 92835
- Pfizer Investigational Site
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Long Beach, California, Verenigde Staten, 90806
- Pfizer Investigational Site
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Mission Viejo, California, Verenigde Staten, 92691
- Pfizer Investigational Site
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Pasadena, California, Verenigde Staten, 91105
- Pfizer Investigational Site
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San Diego, California, Verenigde Staten, 92120
- Pfizer Investigational Site
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San Diego, California, Verenigde Staten, 92128
- Pfizer Investigational Site
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San Luis Obispo, California, Verenigde Staten, 93401
- Pfizer Investigational Site
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Spring Valley, California, Verenigde Staten, 91978
- Pfizer Investigational Site
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Stockton, California, Verenigde Staten, 95204
- Pfizer Investigational Site
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Walnut Creek, California, Verenigde Staten, 94598
- Pfizer Investigational Site
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West Hills, California, Verenigde Staten, 91307
- Pfizer Investigational Site
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Colorado
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Golden, Colorado, Verenigde Staten, 80401
- Pfizer Investigational Site
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Connecticut
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Waterbury, Connecticut, Verenigde Staten, 06708
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Verenigde Staten, 19713
- Pfizer Investigational Site
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Florida
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Chiefland, Florida, Verenigde Staten, 32626
- Pfizer Investigational Site
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Clearwater, Florida, Verenigde Staten, 33765
- Pfizer Investigational Site
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Hollywood, Florida, Verenigde Staten, 33023
- Pfizer Investigational Site
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Kissimmee, Florida, Verenigde Staten, 34741
- Pfizer Investigational Site
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Miami, Florida, Verenigde Staten, 33156
- Pfizer Investigational Site
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Ocala, Florida, Verenigde Staten, 34471
- Pfizer Investigational Site
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Saint Cloud, Florida, Verenigde Staten, 34769
- Pfizer Investigational Site
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Winter Park, Florida, Verenigde Staten, 32789
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Pfizer Investigational Site
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Lawrenceville, Georgia, Verenigde Staten, 30045
- Pfizer Investigational Site
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Lawrenceville, Georgia, Verenigde Staten, 30045-3388
- Pfizer Investigational Site
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Woodstock, Georgia, Verenigde Staten, 30189
- Pfizer Investigational Site
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Idaho
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Boise, Idaho, Verenigde Staten, 83702
- Pfizer Investigational Site
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Hayden Lake, Idaho, Verenigde Staten, 83835
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46254
- Pfizer Investigational Site
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66211
- Pfizer Investigational Site
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Topeka, Kansas, Verenigde Staten, 66606
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
- Pfizer Investigational Site
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Louisville, Kentucky, Verenigde Staten, 40213
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70808
- Pfizer Investigational Site
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New Orleans, Louisiana, Verenigde Staten, 70121
- Pfizer Investigational Site
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Massachusetts
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Haverhill, Massachusetts, Verenigde Staten, 01830-6141
- Pfizer Investigational Site
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Missouri
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Springfield, Missouri, Verenigde Staten, 65807
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68131
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89104
- Pfizer Investigational Site
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New York
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Staten Island, New York, Verenigde Staten, 10301
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28209-3734
- Pfizer Investigational Site
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Statesville, North Carolina, Verenigde Staten, 28625
- Pfizer Investigational Site
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Winston-Salem, North Carolina, Verenigde Staten, 27103
- Pfizer Investigational Site
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Ohio
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Kettering, Ohio, Verenigde Staten, 45429
- Pfizer Investigational Site
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Maumee, Ohio, Verenigde Staten, 43537-9402
- Pfizer Investigational Site
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Toledo, Ohio, Verenigde Staten, 43606
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73103
- Pfizer Investigational Site
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Oregon
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Medford, Oregon, Verenigde Staten, 97504
- Pfizer Investigational Site
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Pennsylvania
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Melrose Park, Pennsylvania, Verenigde Staten, 19027
- Pfizer Investigational Site
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29615
- Pfizer Investigational Site
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Greer, South Carolina, Verenigde Staten, 29651
- Pfizer Investigational Site
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Pfizer Investigational Site
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Tennessee
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Milan, Tennessee, Verenigde Staten, 38358
- Pfizer Investigational Site
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Texas
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Arlington, Texas, Verenigde Staten, 76014-2010
- Pfizer Investigational Site
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Beaumont, Texas, Verenigde Staten, 77701
- Pfizer Investigational Site
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Dallas, Texas, Verenigde Staten, 75231
- Pfizer Investigational Site
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Dallas, Texas, Verenigde Staten, 75230
- Pfizer Investigational Site
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Dallas, Texas, Verenigde Staten, 75246
- Pfizer Investigational Site
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El Paso, Texas, Verenigde Staten, 79935
- Pfizer Investigational Site
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Houston, Texas, Verenigde Staten, 77008
- Pfizer Investigational Site
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Houston, Texas, Verenigde Staten, 77083
- Pfizer Investigational Site
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San Antonio, Texas, Verenigde Staten, 78229
- Pfizer Investigational Site
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San Antonio, Texas, Verenigde Staten, 78229-3900
- Pfizer Investigational Site
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Vermont
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Bennington, Vermont, Verenigde Staten, 05201-5018
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Verenigde Staten, 23249
- Pfizer Investigational Site
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Washington
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Federal Way, Washington, Verenigde Staten, 98003
- Pfizer Investigational Site
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Wisconsin
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Menomonee Falls, Wisconsin, Verenigde Staten, 53051
- Pfizer Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2007
Primaire voltooiing (Werkelijk)
1 augustus 2008
Studie voltooiing (Werkelijk)
1 augustus 2008
Studieregistratiedata
Eerst ingediend
3 januari 2007
Eerst ingediend dat voldeed aan de QC-criteria
4 januari 2007
Eerst geplaatst (Geschat)
5 januari 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
20 juli 2026
Laatst geverifieerd
1 juli 2025
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Metabole ziekten
- Glucosemetabolismestoornissen
- Suikerziekte
- Voedings- en stofwisselingsziekten
- Diabetes mellitus, type 2
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Peptide hormonen
- Peptiden
- Aminozuren, peptiden en eiwitten
- Insuline, langwerkend
- Insulines
- Pancreashormonen
- Insuline Glargine
- Exubera
Andere studie-ID-nummers
- A2171095
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .