Diabetes Mellitus Type 2 Clinical Trial
Official title:
A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents
| Verified date | April 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 354 |
| Est. completion date | February 19, 2008 |
| Est. primary completion date | February 19, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Diabetes mellitus type 2 - Failing two or more oral anti-diabetic agents Exclusion Criteria: - Asthma, COPD - Smoking |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Maritime Research Center | Bathurst | New Brunswick |
| Canada | Laboratoire Sante Le Gaspesien Inc. | Bonaventure | Quebec |
| Canada | Douglas Tweel M.D. Professional Corporation | Charlottetown | Prince Edward Island |
| Canada | Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire | Chicoutimi | Quebec |
| Canada | Gain Medical Center | Coquitlam | British Columbia |
| Canada | Rhodin Recherche Clinique | Drummondville | Quebec |
| Canada | Q & T Research Outaouais Inc. | Gatineau | Quebec |
| Canada | Hopital Charles LeMoyne | Greenfield Park | Quebec |
| Canada | Office of Dr. Salim Sunderji | London | Ontario |
| Canada | Orillia Soldier's Memorial Hospital | Orillia | Ontario |
| Canada | Hopital Laval | Saint-Foy | Quebec |
| Canada | Centre Medical des Carrieres | St-Marc-des-Carrieres | Quebec |
| Canada | CIC Mauricie Inc. | Trois-Rivières | Quebec |
| Canada | Misericordia Health Centre | Winnipeg | Manitoba |
| France | Groupe Hospitalier Sud/Service d'Endocrinologie | Amiens cedex 1 | |
| France | Private Practise | Armentieres | |
| France | Service d'Endocrinologie- | Bondy Cedex | |
| France | Hopital LA Cavale Blanche, Service de Diabetologie | Brest CEDEX | |
| France | CHU Cote de Nacre, Service d'Endocrinologie | Cean Cedex | |
| France | Private Practise | Chartres | |
| France | Office of Antoine Lemaire, MD | Lille | |
| France | Centre Hospitalier Bretagne Sud | Lorient Cedex | |
| France | Hopital Lapeyronnie Sce des Maladies | Montpellier CEDEX 5 | |
| France | Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition | Nantes | Cedex 01 |
| France | Hopital Saint Michel | Paris | |
| France | Hopital Bichat, Service d'Endocrinology | Paris Cedex 18 | |
| France | Hopital Robert Debre | Reims | |
| France | C.H. Sud, Diabetologie | Rennes | |
| France | Centre Hospitalier Victor Provo | Roubaix | |
| France | Hôpital Jeanne d'Arc - Dommartin les Toul | Toul Cedex | |
| Greece | "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic | Athens | |
| Greece | General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic | Athens | |
| Greece | "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic | Haidari | |
| Greece | Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department | Pireaus | |
| Greece | University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin | Thessaloniki | |
| Portugal | Hospital Infante D. Pedro | Aveiro | |
| Portugal | Hospitais da Universidade de Coimbra | Coimbra | |
| Portugal | Associação Protectora dos Diabéticos de Portugal | Lisboa | |
| Portugal | Serviço de Endocrinologia - Hospital de Egas Moniz | Lisboa | |
| Portugal | Hospital Geral de Santo António | Porto | |
| Portugal | Centro Hospitalar de Torres Vedras | Torres Vedras | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital de La Santa Creu I Sant Pau | Barcelona | |
| Spain | Hospital General Universitario Valle de Hebron | Barcelona | |
| Spain | Hospital de Bellvitge | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital de Mostoles | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro | Madrid | |
| Spain | Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C | Malaga | |
| Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
| Spain | Clinica Universitaria de Navarra | Pamplona | Navarra |
| Spain | Hospital Montecelo | Pontevedra | |
| Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | A Coruña |
| Spain | Hospital de Conxo | Santiago de Compostela | A Coruña |
| Spain | Hospital Mutua de Terrassa | Terrassa | Barcelona |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| Spain | Hospital Universitario La Fe | Valencia | |
| Spain | Hospital Clinico Universitario Lozano Blesa | Zaragoza | |
| Sweden | Ängelholms sjukhus | Ängelholm | |
| Sweden | Karolinska US Huddinge | Stockholm | |
| Sweden | Sodersjukhuset | Stockholm | |
| Turkey | Hacettepe University Medical School Department of Endocrinology | Anakara | |
| Turkey | Istanbul University Istanbul Medical School, Department of Endocrinology | Istanbul | |
| Turkey | Dokuz Eylul University Medical School, Department of Endocrinology | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Canada, France, Greece, Portugal, Spain, Sweden, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | [(week 24 value - baseline value)/baseline value]*100% | 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% | 4, 12 and 24 weeks | |
| Secondary | Change From Baseline in FEV1 at Week 24 LOCF | 24 weeks |
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