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inhaled PEG-insulin--Nektar, PEGylated insulin--Nektar", "creators": [], "abstractNote": "Nektar Therapeutics (formerly Inhale Therapeutic Systems) has developed a pulmonary drug delivery system for insulin [HMR 4006, Exubera]. The rationale behind developing a pulmonary drug delivery system is to ensure that insulin powder is delivered deep into the lungs, where it is easily absorbed into the bloodstream, in a hand-held inhalation device. The device converts the insulin powder particles into an aerosol cloud for the patient to inhale. No propellants are used. The inhaler requires no power source and the clear chamber ensures that the patient knows immediately when all the insulin has been inhaled. Nektar Therapeutics, developers of the inhalation device and formulation process, has licensed the system to Pfizer. Under the terms of the agreement, Pfizer will lead the clinical development of inhaled insulin, while working with Nektar Therapeutics to develop the technology required for packaging the product. Pfizer has an agreement with Hoechst Marion Roussel (now Aventis Pharma) for developing, manufacturing and promoting inhaled insulin. Under the terms of the collaboration, Aventis Pharma will supply recombinant insulin to Nektar Therapeutics to process it into dry powder for incorporation into the inhaler device. Nektar Therapeutics will receive royalties on sales of inhaled insulin marketed by Pfizer and Aventis Pharma, and milestone payments and research support from Pfizer. Aventis Pharma's codename for the product is HMR 4006.Profil, a CRO in Germany, is cooperating with Pfizer/Aventis Pharma in the development of inhaled insulin. In March 2004, Pfizer and Aventis announced that the European Medicines Evaluation Agency (EMEA) accepted the filing of the MAA for inhaled insulin (Exubera) for the treatment of type 1 and type 2 diabetes mellitus. The two companies are working with the US FDA to determine the timing for the submission of the NDA in the US. Pfizer completed five pivotal phase III clinical trials with inhaled insulin in patients with type 1 and type 2 diabetes mellitus in 120 centres worldwide, and will use a fourth prototype inhaler device that is half the size of the first prototype, and has reduced manufacturing costs. Pfizer and its partner, Aventis Pharma, are conducting additional long-term pulmonary safety data studies in patients with type 1 and type 2 diabetes. Pfizer is also conducting phase III clinical trials with inhaled insulin in paediatric patients aged 6-17 years. Nektar Therapeutics is using its Advanced PEGylation technology to develop a dry powder-inhaled polyethylene glycol (PEG) formulation for delivering peptides efficiently across the lungs and to promote prolonged serum concentration of the peptide. PEG is a neutral, water-soluble, nontoxic polymer comprising any number of repeating units of ethylene oxide. 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"ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/XQJ2AFJ8", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_437/items/XQJ2AFJ8", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2038579, "username": "jmarantidis", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/jmarantidis", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "XQJ2AFJ8", "version": 3, "itemType": "webpage", "title": "Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents - Full Text View - ClinicalTrials.gov", "creators": [], "abstractNote": "", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "https://clinicaltrials.gov/ct2/show/NCT00479258?term=inhaled+insulin&rank=10", "accessDate": "2015-09-10T00:34:57Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-09-10T00:49:27Z", "dateModified": "2015-09-10T00:49:27Z" } }, { "key": "FBV7MT23", "version": 3, "library": { "type": "group", "id": 398339, "name": "ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/FBV7MT23", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_437/items/FBV7MT23", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2038579, "username": "jmarantidis", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/jmarantidis", "type": "text/html" } } }, "creatorSummary": "Petrak et al.", "parsedDate": "2013-07-11", "numChildren": 0 }, "data": { "key": "FBV7MT23", "version": 3, "itemType": "journalArticle", "title": "Psychological Insulin Resistance in Type 2 Diabetes Patients Regarding Oral Antidiabetes Treatment, Subcutaneous Insulin Injections, or Inhaled Insulin", "creators": [ { "creatorType": "author", "firstName": "Frank", "lastName": "Petrak" }, { "creatorType": "author", "firstName": "Stephan", "lastName": "Herpertz" }, { "creatorType": "author", "firstName": "Elmar", "lastName": "Stridde" }, { "creatorType": "author", "firstName": "Andreas", "lastName": "Pfützner" } ], "abstractNote": "Background: “Psychological insulin resistance” (PIR) is an obstacle to insulin treatment in type 2 diabetes, and patients' expectations regarding alternative ways of insulin delivery are poorly understood. Subjects and Methods: PIR and beliefs regarding treatment alternatives were analyzed in patients with type 2 diabetes (n=532; mean glycated hemoglobin, 68±12 mmol/mol [8.34±1.5%]) comparing oral antidiabetes treatment, subcutaneous insulin injections, or inhaled insulin. Questionnaires were used to assess barriers to insulin treatment (BIT), generic and diabetes-specific quality of life (Short Form 36 and Problem Areas in Diabetes, German version), diabetes knowledge, locus of control (Questionnaire for the Assessment of Diabetes-Specific Locus of Control, in German), coping styles (Freiburg Questionnaire of Illness Coping, 15-Items Short Form), self-esteem (Rosenberg Self-Esteem Scale, German version), and mental disorders (Patient Health Questionnaire, German version). Patients discussed treatment optimization options with a physician and were asked to make a choice about future diabetes therapy options in a two-step treatment choice scenario. Step 1 included oral antidiabetes drugs or subcutaneous insulin injection (SCI). Step 2 included an additional treatment alternative of inhaled insulin (INH). Subgroups were analyzed according to their treatment choice. Results: Most patients perceived their own diabetes-related behavior as active, problem-focused, internally controlled, and oriented toward their doctors' recommendations, although their diabetes knowledge was limited. In Step 1, rejection of the recommended insulin was 82%, and in Step 2, it was 57%. Fear of hypoglycemia was the most important barrier to insulin treatment. Patients choosing INH (versus SCI) scored higher regarding fear of injection, expected hardship from insulin therapy, and BIT-Sumscore. Conclusions: The acceptance of insulin is very low in type 2 diabetes patients. The option to inhale insulin increases the acceptability for some but not the majority of patients.", "publicationTitle": "Diabetes Technology & Therapeutics", "publisher": "", "place": "", "date": "July 11, 2013", "volume": "15", "issue": "8", "section": "", "partNumber": "", "partTitle": "", "pages": "702-710", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Diabetes Technology & Therapeutics", "DOI": "10.1089/dia.2012.0257", "citationKey": "", "url": "http://online.liebertpub.com/doi/abs/10.1089/dia.2012.0257", "accessDate": "2015-09-10T00:32:49Z", "PMID": "", "PMCID": "", "ISSN": "1520-9156", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "online.liebertpub.com (Atypon)", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-09-10T00:49:27Z", "dateModified": "2015-09-10T00:49:27Z" } }, { "key": "DWABKKS7", "version": 3, "library": { "type": "group", "id": 398339, "name": "ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/DWABKKS7", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_437/items/DWABKKS7", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2038579, "username": "jmarantidis", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/jmarantidis", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "DWABKKS7", "version": 3, "itemType": "webpage", "title": "A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus - Full Text View - ClinicalTrials.gov", "creators": [], "abstractNote": "", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "https://clinicaltrials.gov/ct2/show/NCT00282971?term=inhaled+insulin&rank=1", "accessDate": "2015-09-10T00:34:24Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-09-10T00:49:27Z", "dateModified": "2015-09-10T00:49:27Z" } }, { "key": "US4MRKS4", "version": 3, "library": { "type": "group", "id": 398339, "name": "ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/US4MRKS4", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_437/items/US4MRKS4", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2038579, "username": "jmarantidis", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/jmarantidis", "type": "text/html" } } }, "parsedDate": "2015-06-02", "numChildren": 0 }, "data": { "key": "US4MRKS4", "version": 3, "itemType": "journalArticle", "title": "AN inhaled insulin (afrezza)", "creators": [], "abstractNote": "The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza–Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.1", "publicationTitle": "JAMA", "publisher": "", "place": "", "date": "June 2, 2015", "volume": "313", "issue": "21", "section": "", "partNumber": "", "partTitle": "", "pages": "2176-2177", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "JAMA", "DOI": "10.1001/jama.2015.5634", "citationKey": "", "url": "http://dx.doi.org/10.1001/jama.2015.5634", "accessDate": "2015-09-10T00:29:50Z", "PMID": "", "PMCID": "", "ISSN": "0098-7484", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "Silverchair", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-09-10T00:49:27Z", "dateModified": "2015-09-10T00:49:27Z" } }, { "key": "BVIWT964", "version": 3, "library": { "type": "group", "id": 398339, "name": "ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/BVIWT964", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_437/items/BVIWT964", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2038579, "username": "jmarantidis", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/jmarantidis", "type": "text/html" } } }, "creatorSummary": "Derosa and Maffioli", "parsedDate": "2015", "numChildren": 0 }, "data": { "key": "BVIWT964", "version": 3, "itemType": "journalArticle", "title": "Inhaled insulin: weighing the pros and cons", "creators": [ { "creatorType": "author", "firstName": "Giuseppe", "lastName": "Derosa" }, { "creatorType": "author", "firstName": "Pamela", "lastName": "Maffioli" } ], "abstractNote": "", "publicationTitle": "The Lancet Diabetes & Endocrinology", "publisher": "", "place": "", "date": "9/2015", "volume": "", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1016/S2213-8587(15)00317-4", "citationKey": "", "url": "http://linkinghub.elsevier.com/retrieve/pii/S2213858715003174", "accessDate": "2015-09-10T00:33:48Z", "PMID": "", "PMCID": "", "ISSN": "22138587", "archive": "", "archiveLocation": "", "shortTitle": "Inhaled insulin", "language": "en", "libraryCatalog": "CrossRef", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-09-10T00:49:27Z", "dateModified": "2015-09-10T00:49:27Z" } }, { "key": "9P352N5T", "version": 14, "library": { "type": "group", "id": 398339, "name": "ALS 437", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_437", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/398339/items/9P352N5T", "type": "application/json" }, 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