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| ID | Type | Description | Link |
|---|---|---|---|
| EXACTA | Other Identifier | Alias Study Number | |
| 2005-003504-11 | EudraCT Number |
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Terminated as marketing of this product will be discontinued
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To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Insulin | Experimental | Inhaled insulin plus oral therapy |
|
| Standard of Care | Other | Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Insulin (Exubera) | Drug | Addition of inhaled insulin to pre-existing oral diabetes therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | [(week 24 value - baseline value)/baseline value]*100% | 4, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Glycemic Control by Visit | 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0% | 4, 12 and 24 weeks |
| Change From Baseline in FEV1 at Week 24 LOCF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gain Medical Center | Coquitlam | British Columbia | V3K 3P4 | Canada | ||
| Misericordia Health Centre |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Insulin | Inhaled insulin plus oral therapy |
| FG001 | Standard of Care | Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard of Care | Other | Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators |
|
| 24 weeks |
| Winnipeg |
| Manitoba |
| R3C 1A2 |
| Canada |
| Maritime Research Center | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Office of Dr. Salim Sunderji | London | Ontario | N6P 1A9 | Canada |
| Orillia Soldier's Memorial Hospital | Orillia | Ontario | L3V 2Z6 | Canada |
| Douglas Tweel M.D. Professional Corporation | Charlottetown | Prince Edward Island | C1A 1L2 | Canada |
| Laboratoire Sante Le Gaspesien Inc. | Bonaventure | Quebec | G0C 1E0 | Canada |
| Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Rhodin Recherche Clinique | Drummondville | Quebec | J2B 1H8 | Canada |
| Q & T Research Outaouais Inc. | Gatineau | Quebec | J8Y 6S9 | Canada |
| Hopital Charles LeMoyne | Greenfield Park | Quebec | J4V2H1 | Canada |
| Hopital Laval | Saint-Foy | Quebec | G1V 4G5 | Canada |
| Centre Medical des Carrieres | Saint-Marc-des-Carrieres | Quebec | G0A 4B0 | Canada |
| CIC Mauricie Inc. | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition | Nantes | Cedex 01 | F-44035 | France |
| Groupe Hospitalier Sud/Service d'Endocrinologie | Amiens | 80094 | France |
| Private Practise | Armentières | 59427 | France |
| Service d'Endocrinologie- | Bondy | 93143 | France |
| Hopital LA Cavale Blanche, Service de Diabetologie | Brest | 29609 | France |
| CHU Cote de Nacre, Service d'Endocrinologie | Cean Cedex | 14033 | France |
| Private Practise | Chartres | 28000 | France |
| Office of Antoine Lemaire, MD | Lille | 59000 | France |
| Centre Hospitalier Bretagne Sud | Lorient | 56322 | France |
| Hopital Lapeyronnie Sce des Maladies | Montpellier | 34295 | France |
| Hopital Saint Michel | Paris | 75015 | France |
| Hopital Bichat, Service d'Endocrinology | Paris | 75877 | France |
| Hopital Robert Debre | Reims | 51100 | France |
| C.H. Sud, Diabetologie | Rennes | 35056 | France |
| Centre Hospitalier Victor Provo | Roubaix | 59100 | France |
| Hôpital Jeanne d'Arc - Dommartin les Toul | Toul | 54201 | France |
| General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic | Athens | 11527 | Greece |
| "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic | Athens | 151 23 | Greece |
| "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic | Haidari | 124 62 | Greece |
| Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department | Pireaus | 18454 | Greece |
| University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin | Thessaloniki | 546 36 | Greece |
| Hospital Infante D. Pedro | Aveiro | 3814-096 | Portugal |
| Hospitais da Universidade de Coimbra | Coimbra | 3000-075 | Portugal |
| Associação Protectora dos Diabéticos de Portugal | Lisbon | 1250-203 | Portugal |
| Serviço de Endocrinologia - Hospital de Egas Moniz | Lisbon | 1300 | Portugal |
| Hospital Geral de Santo António | Porto | 4099-001 | Portugal |
| Centro Hospitalar de Torres Vedras | Torres Vedras | 2560-324 | Portugal |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hospital de Conxo | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital General Universitario Valle de Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28035 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital de Mostoles | Madrid | 28935 | Spain |
| Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C | Málaga | 29009 | Spain |
| Hospital Montecelo | Pontevedra | 36071 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Ängelholms sjukhus | Ängelholm | 262 81 | Sweden |
| Sodersjukhuset | Stockholm | 118 83 | Sweden |
| Karolinska US Huddinge | Stockholm | 141 86 | Sweden |
| Hacettepe University Medical School Department of Endocrinology | Ankara | Turkey (Türkiye) |
| Istanbul University Istanbul Medical School, Department of Endocrinology | Istanbul | 34390 | Turkey (Türkiye) |
| Dokuz Eylul University Medical School, Department of Endocrinology | Izmir | 35340 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Insulin | Inhaled insulin plus oral therapy |
| BG001 | Standard of Care | Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | [(week 24 value - baseline value)/baseline value]*100% | Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. | Posted | Mean | Standard Deviation | percentage change | 4, 12 and 24 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Glycemic Control by Visit | 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0% | Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward. | Posted | Number | Percentage of participants | 4, 12 and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FEV1 at Week 24 LOCF | Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward. | Posted | Mean | Standard Deviation | Liter | 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Insulin | Inhaled insulin plus oral therapy | 8 | 180 | 123 | 180 | ||
| EG001 | Standard of Care | Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators | 6 | 171 | 98 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Device malfunction | Injury, poisoning and procedural complications | MedDRA (v11.1) | Systematic Assessment |
| |
| Blood glucose increase | Investigations | MedDRA (v11.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v11.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v11.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (v11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (v11.1) | Systematic Assessment |
|
Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of this study.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C473734 | Exubera |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Title | Measurements |
|---|---|
|
| Between 45 and 64 years |
|
| >=65 years |
|
| Male |
|
| week 24 (n=142 and 150, respectively) |
|
| week 24 (LOCF, n=175 and 170, respectively) |
|
|
|