This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
20 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
413
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Carolina, Porto Rico, 00983
- Pfizer Investigational Site
-
-
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85051
- Pfizer Investigational Site
-
Tucson, Arizona, États-Unis, 85712
- Pfizer Investigational Site
-
-
California
-
Concord, California, États-Unis, 94520
- Pfizer Investigational Site
-
Encino, California, États-Unis, 91436
- Pfizer Investigational Site
-
Fresno, California, États-Unis, 93720
- Pfizer Investigational Site
-
Fullerton, California, États-Unis, 92835
- Pfizer Investigational Site
-
Long Beach, California, États-Unis, 90806
- Pfizer Investigational Site
-
Mission Viejo, California, États-Unis, 92691
- Pfizer Investigational Site
-
Pasadena, California, États-Unis, 91105
- Pfizer Investigational Site
-
San Diego, California, États-Unis, 92120
- Pfizer Investigational Site
-
San Diego, California, États-Unis, 92128
- Pfizer Investigational Site
-
San Luis Obispo, California, États-Unis, 93401
- Pfizer Investigational Site
-
Spring Valley, California, États-Unis, 91978
- Pfizer Investigational Site
-
Stockton, California, États-Unis, 95204
- Pfizer Investigational Site
-
Walnut Creek, California, États-Unis, 94598
- Pfizer Investigational Site
-
West Hills, California, États-Unis, 91307
- Pfizer Investigational Site
-
-
Colorado
-
Golden, Colorado, États-Unis, 80401
- Pfizer Investigational Site
-
-
Connecticut
-
Waterbury, Connecticut, États-Unis, 06708
- Pfizer Investigational Site
-
-
Delaware
-
Newark, Delaware, États-Unis, 19713
- Pfizer Investigational Site
-
-
Florida
-
Chiefland, Florida, États-Unis, 32626
- Pfizer Investigational Site
-
Clearwater, Florida, États-Unis, 33765
- Pfizer Investigational Site
-
Hollywood, Florida, États-Unis, 33023
- Pfizer Investigational Site
-
Kissimmee, Florida, États-Unis, 34741
- Pfizer Investigational Site
-
Miami, Florida, États-Unis, 33156
- Pfizer Investigational Site
-
Ocala, Florida, États-Unis, 34471
- Pfizer Investigational Site
-
Saint Cloud, Florida, États-Unis, 34769
- Pfizer Investigational Site
-
Winter Park, Florida, États-Unis, 32789
- Pfizer Investigational Site
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30322
- Pfizer Investigational Site
-
Lawrenceville, Georgia, États-Unis, 30045
- Pfizer Investigational Site
-
Lawrenceville, Georgia, États-Unis, 30045-3388
- Pfizer Investigational Site
-
Woodstock, Georgia, États-Unis, 30189
- Pfizer Investigational Site
-
-
Idaho
-
Boise, Idaho, États-Unis, 83702
- Pfizer Investigational Site
-
Hayden Lake, Idaho, États-Unis, 83835
- Pfizer Investigational Site
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46254
- Pfizer Investigational Site
-
-
Kansas
-
Overland Park, Kansas, États-Unis, 66211
- Pfizer Investigational Site
-
Topeka, Kansas, États-Unis, 66606
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40503
- Pfizer Investigational Site
-
Louisville, Kentucky, États-Unis, 40213
- Pfizer Investigational Site
-
-
Louisiana
-
Baton Rouge, Louisiana, États-Unis, 70808
- Pfizer Investigational Site
-
New Orleans, Louisiana, États-Unis, 70121
- Pfizer Investigational Site
-
-
Massachusetts
-
Haverhill, Massachusetts, États-Unis, 01830-6141
- Pfizer Investigational Site
-
-
Missouri
-
Springfield, Missouri, États-Unis, 65807
- Pfizer Investigational Site
-
-
Nebraska
-
Omaha, Nebraska, États-Unis, 68131
- Pfizer Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89104
- Pfizer Investigational Site
-
-
New York
-
Staten Island, New York, États-Unis, 10301
- Pfizer Investigational Site
-
-
North Carolina
-
Charlotte, North Carolina, États-Unis, 28209-3734
- Pfizer Investigational Site
-
Statesville, North Carolina, États-Unis, 28625
- Pfizer Investigational Site
-
Winston-Salem, North Carolina, États-Unis, 27103
- Pfizer Investigational Site
-
-
Ohio
-
Kettering, Ohio, États-Unis, 45429
- Pfizer Investigational Site
-
Maumee, Ohio, États-Unis, 43537-9402
- Pfizer Investigational Site
-
Toledo, Ohio, États-Unis, 43606
- Pfizer Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, États-Unis, 73103
- Pfizer Investigational Site
-
-
Oregon
-
Medford, Oregon, États-Unis, 97504
- Pfizer Investigational Site
-
-
Pennsylvania
-
Melrose Park, Pennsylvania, États-Unis, 19027
- Pfizer Investigational Site
-
-
South Carolina
-
Greenville, South Carolina, États-Unis, 29615
- Pfizer Investigational Site
-
Greer, South Carolina, États-Unis, 29651
- Pfizer Investigational Site
-
Spartanburg, South Carolina, États-Unis, 29303
- Pfizer Investigational Site
-
-
Tennessee
-
Milan, Tennessee, États-Unis, 38358
- Pfizer Investigational Site
-
-
Texas
-
Arlington, Texas, États-Unis, 76014-2010
- Pfizer Investigational Site
-
Beaumont, Texas, États-Unis, 77701
- Pfizer Investigational Site
-
Dallas, Texas, États-Unis, 75231
- Pfizer Investigational Site
-
Dallas, Texas, États-Unis, 75230
- Pfizer Investigational Site
-
Dallas, Texas, États-Unis, 75246
- Pfizer Investigational Site
-
El Paso, Texas, États-Unis, 79935
- Pfizer Investigational Site
-
Houston, Texas, États-Unis, 77008
- Pfizer Investigational Site
-
Houston, Texas, États-Unis, 77083
- Pfizer Investigational Site
-
San Antonio, Texas, États-Unis, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, États-Unis, 78229-3900
- Pfizer Investigational Site
-
-
Vermont
-
Bennington, Vermont, États-Unis, 05201-5018
- Pfizer Investigational Site
-
-
Virginia
-
Richmond, Virginia, États-Unis, 23249
- Pfizer Investigational Site
-
-
Washington
-
Federal Way, Washington, États-Unis, 98003
- Pfizer Investigational Site
-
-
Wisconsin
-
Menomonee Falls, Wisconsin, États-Unis, 53051
- Pfizer Investigational Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
30 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
Délai: Baseline, Week 26
|
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
|
Baseline, Week 26
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, Week 26
|
BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
|
Baseline, Week 26
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
Délai: Baseline, Week 26
|
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
|
Baseline, Week 26
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2007
Achèvement primaire (Réel)
1 août 2008
Achèvement de l'étude (Réel)
1 août 2008
Dates d'inscription aux études
Première soumission
3 janvier 2007
Première soumission répondant aux critères de contrôle qualité
4 janvier 2007
Première publication (Estimé)
5 janvier 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 juillet 2026
Dernière vérification
1 juillet 2025
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Maladies nutritionnelles et métaboliques
- Diabète sucré, Type 2
- Hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Hormones peptidiques
- Peptides
- Acides aminés, peptides et protéines
- Insuline, à longue durée
- Insulines
- Hormones pancréatiques
- Insuline Glargine
- Exubera
Autres numéros d'identification d'étude
- A2171095
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .