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| EXAMINATION | - Cheng Sam Tsz Wai, Chen Lihua, Li Stephen Yu Ting, Mayoux Eric, Leung Po Sing, "The Effects of Empagliflozin, an SGLT2 Inhibitor, on Pancreatic β-Cell Mass and Glucose Homeostasis in Type 1 Diabetes", PLOS ONE, vol. 11, no. 1, doi:10.1371/journal.pone.0147391, page e0147391, XP093056276 | |
| EXAMINATION | - BRUCE A. PERKINS ET AL, "Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial", DIABETES CARE, US, (20140304), vol. 37, no. 5, doi:10.2337/dc13-2338, ISSN 0149-5992, pages 1480 - 1483, XP055269585 | |
| EXAMINATION | - JULIO ROSENSTOCK ET AL, "Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes", DIABETES CARE, US, (20140614), vol. 37, no. 7, doi:10.2337/dc13-3055, ISSN 0149-5992, pages 1815 - 1823, XP055269594 | |
| OPPOSITION | - Aires Inês, Calado Joaquim, "BI-10773, a sodium-glucose cotransporter 2 inhibitor for the potential oral treatment of type 2 diabetes mellitus", Current Opinion in Investigational Drugs, Thomson Reuters (Scientific) Ltd., London, UK, London, UK , (20101101), vol. 11, no. 10, ISSN 2040-3429, pages 1182 - 1190, XP093316302 | - |
| OPPOSITION | - "Annex 1 - Summary of product Characteristics - Jardiance", European Medicine Agency, (20190214), pages 1 - 47, (20211123), XP055864630 | - |
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| OPPOSITION | - Boehringer Ingelheim, "NCT01011868 | Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes", ClinicalTrials.gov, NLM, pages 1 - 22, ClinicalTrials.gov, URL: https://www.clinicaltrials.gov/study/NCT01011868?tab=history&a=13#version-content-panel, XP093317904 | - |
| OPPOSITION | - D10 - ClinicalTrials.gov: "Efficacy and Safety of BI 10773 in combination with insulin patients with Type 2 Diabetes", ClinicalTrials.gov ID NCT010118, V13 (2010-10-18) | - |
| OPPOSITION | - D17 - Submission of 17 April 2020 in the examination proceedings of EP 19 163 940.0 | - |
| OPPOSITION | - D23 - Annex to the Communication pursuant to Article 94(3) EPC of 17.11.2020 | - |
| OPPOSITION | - D24 - Submission of 16 August 2021 in the examination proceedings of EP 19 163 940.0 16.09.202 | - |
| OPPOSITION | - D41 - Informationsbrief : Aktualisierte Hinweise zum Risiko einer diabetischen Ketoazidose während der Behandlung mit SGLT2‐Inhibitoren | - |
| OPPOSITION | - D42 - Risiko einer Fournier Gangrän (Nekrotisierende Fasziitis des Perineums) bei der Anwendung von SGLT2-Inhibitoren („Sodium-Glucose-Co-Transporter 2 Inhibitors“) 21-01-2019 | - |
| OPPOSITION | - D43 - Forxiga (Dapagliflozin) 5 mg darf nicht mehr zur Behandlung von Typ-1-Diabetes Mellitus angewendet werden ; 10-2021 | - |
| OPPOSITION | - D47 - WebMD - What is reactive Hypoglycemia - DiLonardo M. - 05-April-2024 | - |
| OPPOSITION | - D4a - Abstract of Sodium Glucose Co transporter 2 (SGLT2) Inhibitors: A New Sword for the Treatment of Type 2 Diabetes Mellitus | - |
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| OPPOSITION | - Fowler Michael J, "Diabetes Foundation - Hypoglycemia", Clinical Diabetes, (20080101), vol. 26, no. 4, pages 170 - 173, XP093316262 | - |
| OPPOSITION | - "Glycaemic Emergencies in Adults", University of Warwick, University of Warwick, URL: https://warwick.ac.uk/fac/sci/med/research/hsri/emergencycare/prehospitalcare/jrcalcstakeholderwebsite/guidelines/glycaemic_emergencies_in_adults_2006.pdf, XP093318215 | - |
| OPPOSITION | - "Hyperglycemia vs. Hypoglycemia: What you need to know", Wound Care Solutions, Wound Care Solutions, URL: https://www.woundcareinc.com/resources/hyperglycemia-vs-hypoglycemia-what-you-need-to-know, XP093318212 | - |
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| OPPOSITION | - "Jardiance® (empagliflozin) tablets has a demonstrated safety and tolerability profile across multiple trials", Boehringer Ingelheim, Boehringer Ingelheim, URL: https://pro.boehringer-ingelheim.com/us/products/jardiance/t2d/safety, XP093317766 | - |
| OPPOSITION | - "Low Blood Glucose (Hypoglycemia)", National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, URL: https://www.niddk.nih.gov/health-information/diabetes/preventing-diabetes-problems/low-blood-glucose-hypoglycemia, (20160913), XP055302151 | - |
| OPPOSITION | - Mayfield Jennifer A., White Russell D., "Insulin therapy for type 2 diabetes: Rescue, augmentation, and replacement of beta-cell function", AMERICAN FAMILY PHYSICIAN, American Academy of Family Physicians, US, US , (20040801), vol. 70, no. 3, ISSN 0002-838X, pages 489 - 512, XP093318202 | - |
| OPPOSITION | - Rajesh R, Naren Patel, Vidyasagar Sudha, Pandey Sureshwar, Gang Sagar, "Sodium Glucose Co transporter 2 (SGLT2) Inhibitors: A New Sword for the Treatment of Type 2 Diabetes Mellitus", International Journal of Pharma Sciences and Research (IJPSR), (20100101), vol. 1, no. 2, pages 139 - 147, XP093316272 | - |
| OPPOSITION | - Rosenstock Julio, Jelaska Ante, Wang Fei, Kim Gabriel Broedl Uli, Woerle Hans J, Singh Bajaj Harpreet, "Empagliflozin as Add On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM) ", Abstracts / Can J Diabetes, (20130101), vol. 37, page S32, XP093319541 | - |
| OPPOSITION | - Simó Rafael, Cristina Hernandez, "Treatment of Diabetes Mellitus: General Goals and Clinical Practice Management", Rev Esp Cardiol, (20020101), vol. 55, no. 8, pages 845 - 860, XP093318206 | - |
| OPPOSITION | - Stanisstreet Debbie, Walden Esther, Jones Christine, Graveling Alex, "The Hospital Management of Hypoglycaemia in Adults with Diabetes Mellitus", NHS, (20100301), pages 1 - 28, XP093316368 | - |
| OPPOSITION | - "Summary of Product Characteristics (SmP) of the marketed product Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets", Summary of Product Characteristics (SmP) Jardiance (empagliflozin), European Medicines Agency, pages 1 - 59, Summary of Product Characteristics (SmP) Jardiance (empagliflozin), URL: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf, XP093317898 | - |
| OPPOSITION | - Watkins Peter, "Hypoglycaemia: the major hazard of insulin treatment", Journal of Diabetes Nursing, (19980101), vol. 2, no. 4, pages 123 - 126, XP093318209 | - |
| OPPOSITION | - Yurgin Nicole Rae, Boye Kristina Secnik, Dilla Tatiana, Suriñach Núria Lara, Llach Xavier Badia, "Physician and patient management of type 2 diabetes and factors related to glycemic control in Spain", Patient Preference and Adherence, Dove Press Limited, (20080201), vol. 2, ISSN 1177-889X, pages 87 - 95, XP093318211 | - |
| OPPOSITION | - UK Hypoglycaemia Study Group, "Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration", Diabetologia, Springer, Berlin, DE, Berlin, DE , (20070406), vol. 50, no. 6, doi:10.1007/s00125-007-0599-y, ISSN 1432-0428, pages 1140 - 1147, XP019510552 | |
| OPPOSITION | - V. Fonseca ; A. Schweizer ; D. Albrecht ; M. A. Baron ; I. Chang ; S. Dejager, "Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes", Diabetologia, Springer, Berlin, DE, Berlin, DE , (20070327), vol. 50, no. 6, doi:10.1007/s00125-007-0633-0, ISSN 1432-0428, pages 1148 - 1155, XP019510578 | |
| OPPOSITION | - Patel A K; Fonseca V, "Turning Glucosuria into a therapy: Efficacy and safety with SGLT2 inhibitors", CURRENT DIABETES REPORTS, CURRENT SCIENCE, PHILADELPHIA, VA, US, US , (20100401), vol. 10, no. 2, doi:10.1007/s11892-010-0095-5, ISSN 1534-4827, pages 101 - 107, XP009154665 | |
| OPPOSITION | - Kohler Sven; Salsali Afshin; Hantel Stefan; Kaspers Stefan; Woerle Hans J.; Kim Gabriel; Broedl Uli C., "Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes", Clinical Therapeutics, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20160413), vol. 38, no. 6, doi:10.1016/j.clinthera.2016.03.031, ISSN 0149-2918, pages 1299 - 1313, XP029616344 | |
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| OPPOSITION | - Chao Edward C; Henry Robert R, "SGLT2 inhibition - a novel strategy for diabetes treatment", Nature Reviews. Drug Discovery, Nature Publishing Group, GB, GB , (20100701), vol. 9, doi:10.1038/nrd3180, ISSN 1474-1784, pages 551 - 559, XP009139981 | |
| OPPOSITION | - The Diabetes Control and Complications Trial Research Group, "The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus", New England Journal of Medicine, (19930930), vol. 329, no. 14, doi:10.1056/NEJM199309303291401, ISSN 00284793, pages 977 - 986, XP055050395 | |
| OPPOSITION | - Vallon Volker, Sharma Kumar, "Sodium-glucose transport: role in diabetes mellitus and potential clinical implications : ", Current Opinion in Nephrology & Hypertension, Lippincott Williams & Wilkins, Ltd., GB, GB , (20100901), vol. 19, no. 5, doi:10.1097/MNH.0b013e32833bec06, ISSN 1062-4821, pages 425 - 431, XP093316281 | |
| OPPOSITION | - J. Rosenstock; A. Jelaska; C. Zeller; G. Kim; U. C. Broedl; H. J. Woerle, "Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78‐week randomized, double‐blind, placebo‐controlled trial", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20150714), vol. 17, no. 10, doi:10.1111/dom.12503, ISSN 1462-8902, pages 936 - 948, XP072206863 | |
| OPPOSITION | - L. Zhang; Y. Feng; J. List; S. Kasichayanula; M. Pfister, "Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight", Diabetes, Obesity and Metabolism, GB , (20100304), vol. 12, no. 6, doi:10.1111/j.1463-1326.2010.01216.x, ISSN 1462-8902, pages 510 - 516, XP072208890 | |
| OPPOSITION | - G. Luippold; T. Klein; M. Mark; R. Grempler, "Empagliflozin, a novel potent and selective SGLT‐2 inhibitor, improves glycaemic control alone and in combination with insulin in streptozotocin‐induced diabetic rats, a model of type 1 diabetes mellitus", Diabetes, Obesity and Metabolism, GB , (20120223), vol. 14, no. 7, doi:10.1111/j.1463-1326.2012.01569.x, ISSN 1462-8902, pages 601 - 607, XP072206908 | |
| OPPOSITION | - "Recommendations on the Proper Use of SGLT2 Inhibitors", Journal of Diabetes Investigation, AU, (20200101), vol. 11, no. 1, doi:10.1111/jdi.13160, ISSN 2040-1116, pages 257 - 261, XP093319576 | |
| OPPOSITION | - Horii Takeshi, Oikawa Yoichi, Kunisada Narumi, Shimada Akira, Atsuda Koichiro, "Real-world risk of hypoglycemia-related hospitalization in Japanese patients with type 2 diabetes using SGLT2 inhibitors: a nationwide cohort study", BMJ open diabetes research & care, (20201101), vol. 8, no. 2, doi:10.1136/bmjdrc-2020-001856, ISSN 2052-4897, page e001856, XP093319566 | |
| OPPOSITION | - David Z I Cherney, Bruce A Perkins, Nima Soleymanlou, Maria Maione, Vesta Lai, Alana Lee, Nora M Fagan, Hans J Woerle, Odd Erik Johansen, Uli C Broedl, Maximilian von Eynatten, "Renal Hemodynamic Effect of Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 1 Diabetes Mellitus", Circulation, American Heart Association, US, US , (20140204), vol. 129, no. 5, doi:10.1161/CIRCULATIONAHA.113.005081, ISSN 0009-7322, pages 587 - 597, XP055876983 | |
| OPPOSITION | - Cryer Philip E., Axelrod Lloyd, Grossman Ashley B., Heller Simon R., Montori Victor M., Seaquist Elizabeth R., Service F. John, "Evaluation and Management of Adult Hypoglycemic Disorders: An Endocrine Society Clinical Practice Guideline", Journal of Clinical Endocrinology and Metabolism, The Endocrine Society, US, US , (20090301), vol. 94, no. 3, doi:10.1210/jc.2008-1410, ISSN 0021-972X, pages 709 - 728, XP093318213 | |
| OPPOSITION | - Nair Sunil, Wilding John P. H., "Sodium Glucose Cotransporter 2 Inhibitors as a New Treatment for Diabetes Mellitus", Journal of Clinical Endocrinology and Metabolism, US , (20100101), vol. 95, no. 1, doi:10.1210/jc.2009-0473, ISSN 0021-972X, pages 34 - 42, XP093316418 | |
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| OPPOSITION | - Cheng Sam Tsz Wai, Chen Lihua, Li Stephen Yu Ting, Mayoux Eric, Leung Po Sing, "The Effects of Empagliflozin, an SGLT2 Inhibitor, on Pancreatic β-Cell Mass and Glucose Homeostasis in Type 1 Diabetes", PLOS ONE, Public Library of Science, US, US , vol. 11, no. 1, doi:10.1371/journal.pone.0147391, ISSN 1932-6203, page e0147391, XP093056276 | |
| OPPOSITION | - WASHBURN WILLIAM N, "Evolution of sodium glucose co-transporter 2 inhibitors as anti-diabetic agents.", Expert opinion on therapeutic patients, Taylor & Francis, GB, GB , (20091101), vol. 19, no. 11, doi:10.1517/13543770903337828, ISSN 1354-3776, pages 1485 - 1499, XP002593697 | |
| OPPOSITION | - J. F. List, V. Woo, E. Morales, W. Tang, F. T. Fiedorek, "Sodium-Glucose Cotransport Inhibition With Dapagliflozin in Type 2 Diabetes", Diabetes care, (20090401), vol. 32, no. 4, doi:10.2337/dc08-1863, ISSN 01495992, pages 650 - 657, XP055012106 | |
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| OPPOSITION | - Wilding John P.H., Norwood Paul, T'joen Caroline, Bastien Arnaud, List James F., Fiedorek Fred T., "A Study of Dapagliflozin in Patients With Type 2 Diabetes Receiving High Doses of Insulin Plus Insulin Sensitizers", DIABETES CARE, US , (20090901), vol. 32, no. 9, doi:10.2337/dc09-0517, ISSN 0149-5992, pages 1656 - 1662, XP093319601 | |
| OPPOSITION | - "Standards of Medical Care in Diabetes—2010", DIABETES CARE, AMERICAN DIABETES ASSOCIATION, US , (20100101), vol. 33, no. Suppl 1, doi:10.2337/dc10-S011, ISSN 0149-5992, pages S11 - S61, XP055592822 | |
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| OPPOSITION | - Julio Rosenstock, Ante Jelaska, Guillaume Frappin, Afshin Salsali, Gabriel Kim, Hans J. Woerle, Uli C. Broedl, "Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes", DIABETES CARE, AMERICAN DIABETES ASSOCIATION, US , (20140701), vol. 37, no. 7, doi:10.2337/dc13-3055, ISSN 0149-5992, pages 1815 - 1823, XP055269594 | |
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