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(Trulicity) Pen and the Semaglutide (Ozempic) Pen
Protocol H9X-MC-B021(b) Crossover Study Comparing Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen NCT03724981 Approval Date: 30-Nov-2018 H9X-MC-B021(b) Clinical Protocol Page 1 Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen Confidential Information The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of dulaglutide (LY2189265), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Dulaglutide (LY2189265) Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on 07 Aug 2018 Amendment (a) Electronically Signed and Approved by Lilly on 11 Sep 2018 Amendment (b) Electronically Signed and Approved by Lilly on date below Approval Date: 30-Nov-2018 GMT LY2189265 H9X-MC-B021(b) Clinical Protocol Page 2 Table of Contents Section Page Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen ............................................................1 Table of Contents........................................................................................................................2 1. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod -
CDR Clinical Review Report for Soliqua
CADTH COMMON DRUG REVIEW Clinical Review Report Insulin glargine and lixisenatide injection (Soliqua) (Sanofi-Aventis) Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin. Service Line: CADTH Common Drug Review Version: Final (with redactions) Publication Date: January 2019 Report Length: 118 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. -
Sulfonylurea Review
Human Journals Review Article February 2018 Vol.:11, Issue:3 © All rights are reserved by Farah Yousef et al. Sulfonylurea Review Keywords: Type II diabetes, Sulfonylurea, Glimipiride, Glybu- ride, Structure Activity Relationship. ABSTRACT Farah Yousef*1, Oussama Mansour2, Jehad Herbali3 Diabetes Mellitus is a chronic disease represented with high 1 Ph.D. candidate in pharmaceutical sciences, Damas- glucose blood levels. Although sulfonylurea compounds are the cus University, Damascus, Syria. second preferred drug to treat Type II Diabetes (TYIID), they are still the most used agents due to their lower cost and as a 2 Assistant Professor in pharmaceutical chimestry, Ti- mono-dosing. Literature divides these compounds according to st nd rd shreen University, Lattakia, Syria their discovery into 1 , 2 , 3 generations. However, only six sulfonylurea compounds are now available for use in the United 3 Assistant Professor in pharmaceutical chimestry, Da- States: Chlorpropamide, Glimepiride, Glipizide, Glyburide, mascus University, Damascus, Syria. Tolazamide, and Tolbutamide. They function by increasing Submission: 24 January 2018 insulin secretion from pancreatic beta cells. Their main active site is ATP sensitive potassium ion channels; Kir 6.2\SUR1; Accepted: 29 January 2018 Published: 28 February 2018 Potassium Inward Rectifier ion channel 6.2\ Sulfonylurea re- ceptor 1. They are sulfonamide derivatives. However, research- ers have declared that sulfonylurea moiety is not the only one responsible for this group efficacy. It has been known that sud- den and acute hypoglycemia incidences and weight gain are the www.ijppr.humanjournals.com two most common adverse effects TYIID the patient might face during treatment with sulfonylurea agents. This review indi- cates the historical development of sulfonylurea and the differ- ences among this group members. -
For the Use of a Registered Medical Practitioner Or a Hospital Or a Laboratory Only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AN
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AND PROLONGED RELEASE METFORMIN HYDROCHLORIDE TABLETS 1. THE DRUG SHOULD BE USED AT FIRST LINE OF THERAPY FOR DIABETES. 2. ADVICE FOR HEALTHCARE PROFESSIONALS • Patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated haematuria should not receive pioglitazone. • Prescribers should review the safety and efficacy of pioglitazone in individuals after 3-6 month of treatment to ensure that only patients who are deriving benefit continue to be treated. Pioglitazone should be stopped in patients who do not respond adequately to treatment (e.g. reduction in Glycosylated haemoglobin HbA1C). • Before starting pioglitazone, the following known risk factors for development of bladder cancer should be assessed in individuals: age, current or past history of smoking, exposure to some occupational or chemotherapy agents such as cyclophosphamide, or previous irradiation of the pelvic region. • Use in elderly patients should be considered carefully before and during treatment because the risk of bladder cancer increases with age. Elderly patients should start on the lowest possible dose and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone. COMPOSITION Each uncoated bilayered tablet contains: . 20 mg (InTeneligliptin Prolonged IP release .………………………..……………….. form) PioglitazoneMetformin Hydrochloride Hydrochloride IP IP …………………..…... equivalent to mg Pio . 15 mg .s Colour:glitazone Quinoline ………………………….…………………… Yellow Excipients ………………………….……………………..... q CLINICAL PHARMACOLOGY Biotenly®-MP contains three oral anti-hyperglycaemic drugs teneligliptin, pioglitazone and metformin hydrochloride used in the management of type-2 diabetes (NIDDM). MECHANISM OF ACTION/PHARMACODYNEMICS Teneligliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. -
IJBCP International Journal of Basic & Clinical Pharmacology the Observational, Cross-Sectional Study of Drug Utilization
Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194771 Original Research Article The observational, cross-sectional study of drug utilization 90% and use of dipeptidyl peptidase-4 inhibitor in the patients with type 2 diabetes mellitus Prashant P. Shivgunde1*, Shantanu R. Joshi2, Archana D. Kodilkar1 1Department of University Research, Maharashtra ABSTRACT University of Health Sciences (MUHS), Mhasrul, Vani- Background: Diabetes is a chronic metabolic disease which affects the quality Dindori Road, Nashik, of life. It leads to multiple complications due to metabolic involvement. Out of Maharashtra, India multiple drugs used to treat diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors 2 Global Herbs Pharmaceuticals, are comparatively new drugs used for type-2-diabetes mellitus (DM) treatment. Pune-Satara Road, Pune, This study aimed to find out the drug utilization (DU) 90% and use of DPP-4 Maharashtra, India inhibitors in patients with type-2-DM. Methods: A prospective, cross-sectional, observational study was conducted at Received: 28 September 2019 a private healthcare clinic of an endocrinologist in Nashik. Type-2-DM patients Revised: 11 October 2019 of both sexes were selected and a total of 199 patients were enrolled in the Accepted: 14 October 2019 study. The consented patients were interviewed and prescription copies were collected. After studying them; statistical analysis was done and results and *Correspondence to: conclusions were drawn. Dr. Prashant P. Shivgunde, Results: Out of total prescribed drugs, 58.77% of drugs were anti-diabetics. It Email: prashantshivgunde@ was observed that the biguanides were most frequently (25.32%) prescribed gmail.com while the least prescribed drugs were meglitinide analogues (0.08%). -
Us 2017 / 0239276 A1
US 20170239276A1 ( 19) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2017/ 0239276 A1 MUTLU et al. ( 43 ) Pub . Date: Aug . 24 , 2017 ( 54 ) PHARMACEUTICAL COMBINATIONS OF ( 30 ) Foreign Application Priority Data SITAGLIPTIN Sep. 5 , 2014 ( TR ) .. .. .. .. .. 2014 / 10448 (71 ) Applicant : SANOVEL ILAC SANAYI VE TICARET ANONIM SIRKETI, Publication Classification ISTANBUL ( TR ) (51 ) Int. Cl. ( 72 ) Inventors : ONUR MUTLU , ISTANBUL ( TR ) ; A61K 31/ 64 (2006 .01 ) ALI TÜRKYILMAZ , ISTANBUL A61K 9 / 20 ( 2006 . 01 ) ( TR ) ; GÜLAY YELKEN , ISTANBUL A61K 9 / 28 ( 2006 . 01 ) ( TR ); MEHTAP SAYDAM , A61K 31/ 4985 ( 2006 . 01 ) ISTANBUL ( TR ) (52 ) U . S . CI. CPC .. .. .. A61K 31 /64 ( 2013 .01 ) ; A61K 31 /4985 ( 21 ) Appl. No. : (2013 .01 ) ; A61K 9 / 2027 ( 2013 .01 ) ; A61K 15 / 507, 946 9 /2054 ( 2013 .01 ) ; A61K 9 / 28 (2013 .01 ) ( 22 ) PCT Filed : Sep . 4 , 2015 (57 ) ABSTRACT (86 ) PCT NONo . : PCT /EP2015 /070251 A pharmaceutical combination comprising sitagliptin or a $ 371 ( c ) ( 1 ) , pharmaceutically acceptable salt thereof in combination ( 2 ) Date : Mar. 1 , 2017 with a sulfonylurea . US 2017 /0239276 A1 Aug . 24 , 2017 PHARMACEUTICAL COMBINATIONS OF 4 - ( 2 , 4 , 5 - trifluorophenyl) butan - 1 - one or (2R ) - 4 - oxo - 4 - [ 3 SITAGLIPTIN ( trifluoromethyl) - 5 ,6 - dihydro [ 1, 2 , 4 ] triazolo [ 4 , 3 - a ]pyrazin FIELD OF INVENTION 7 (8H )- yl )- 1 - ( 2 ,4 ,5 -trifluorophenyl ) butan - 2 - amine) and its [0001 ] The present invention relates to a pharmaceutical chemical structure is shown in the Formula I . combination comprising sitagliptin or a pharmaceutically [0004 ] Sitagliptin is licensed in the US and EU under the acceptable salt thereof in combination with a sulfonylurea name of JANUVIA in the strength of 100 mg, 50 mg, and 25 and at least one pharmaceutically acceptable excipient. -
Meta-Analysis of 11 Heterogeneous Studies Regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin
Hindawi Journal of Diabetes Research Volume 2020, Article ID 6321826, 12 pages https://doi.org/10.1155/2020/6321826 Research Article Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin Katsuya Shibuki ,1,2 Shuji Shimada,1 and Takao Aoyama1 1Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan 2Clinical Research Center, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Tokyo 113-8519, Japan Correspondence should be addressed to Katsuya Shibuki; [email protected] Received 6 April 2020; Revised 24 September 2020; Accepted 22 October 2020; Published 11 November 2020 Academic Editor: Daniela Foti Copyright © 2020 Katsuya Shibuki et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Several clinical trials have addressed the therapeutic strategy of adding dipeptidyl peptidase 4 (DPP-4) inhibitors to the treatment of type 2 diabetes mellitus (DM) inadequately controlled by insulin therapy. However, there is a high degree of heterogeneity in these studies, and the cause of which has not been identified. Methods. We conducted a meta-analysis of randomized controlled trials, which compared the efficacy and safety of adding DPP-4 inhibitors or placebo to insulin therapy; the level of hemoglobin A1c (HbA1c) in the patients was >7.0%, and the duration of treatment was ≥8 weeks. We focused on the mean changes in HbA1c from the baseline (ΔHbA1c) and the incidence of hypoglycemia. -
Multidrug Treatment with Nelfinavir and Cepharanthine Against COVID-19
Supplemental Information Multidrug treatment with nelfinavir and cepharanthine against COVID-19 Hirofumi Ohashi1,2,¶, Koichi Watashi1,2,3,4*, Wakana Saso1,5.6,¶, Kaho Shionoya1,2, Shoya Iwanami7, Takatsugu Hirokawa8,9,10, Tsuyoshi Shirai11, Shigehiko Kanaya12, Yusuke Ito7, Kwang Su Kim7, Kazane Nishioka1,2, Shuji Ando13, Keisuke Ejima14, Yoshiki Koizumi15, Tomohiro Tanaka16, Shin Aoki16,17, Kouji Kuramochi2, Tadaki Suzuki18, Katsumi Maenaka19, Tetsuro Matano5,6, Masamichi Muramatsu1, Masayuki Saijo13, Kazuyuki Aihara20, Shingo Iwami4,7,21,22,23, Makoto Takeda24, Jane A. McKeating25, Takaji Wakita1 1Department of Virology II, National Institute of Infectious Diseases, Tokyo 162-8640, Japan, 2Department of Applied Biological Science, Tokyo University of Science, Noda 278-8510, Japan, 3Institute for Frontier Life and Medical Sciences, Kyoto University, Kyoto 606-8507, Japan, 4MIRAI, JST, Saitama 332-0012, Japan, 5The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan, 6AIDS Research Center, National Institute of Infectious Diseases, Tokyo 162-8640, Japan, 7Department of Biology, Faculty of Sciences, Kyushu University, Fukuoka 812-8581, Japan, 8Cellular and Molecular Biotechnology Research Institute, National Institute of Advanced Industrial Science and Technology, Tokyo 135-0064, Japan, 9Division of Biomedical Science, Faculty of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan, 10Transborder Medical Research Center, University of Tsukuba, Tsukuba 305-8575, Japan, 11Faculty of Bioscience, Nagahama Institute -
(SGLT2) Inhibitors: a Systematic Review and Meta-Analysis
Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-022577 on 1 February 2019. Downloaded from Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis Jennifer R Donnan,1 Catherine A Grandy,1 Eugene Chibrikov,1 Carlo A Marra,1,2 Kris Aubrey-Bassler,3 Karissa Johnston,1 Michelle Swab,3 Jenna Hache,1 Daniel Curnew,1 Hai Nguyen,1 John-Michael Gamble1,4 To cite: Donnan JR, Grandy CA, ABSTRACT Strengths and limitations of this study Chibrikov E, et al. Comparative Objective To estimate the association between the use safety of the sodium glucose of sodium glucose co-transporter-2 (SGLT2) inhibitors ► This study provides a comprehensive systematic co-transporter 2 (SGLT2) and postmarket harms as identified by drug regulatory inhibitors: a systematic review review of potential serious adverse events related agencies. and meta-analysis. BMJ Open to use of sodium glucose co-transporter-2 (SGLT2) Design We conducted a systematic review and meta- 2019;9:e022577. doi:10.1136/ inhibitors identified by drug regulatory agencies. analysis of randomised controlled trials (RCT). Six large bmjopen-2018-022577 ► This study considered select outcomes to provide databases were searched from inception to May 2018. focused attention on the issues concerning regula- ► Prepublication history and Random effects models were used to estimate pooled tors; however, this means that additional knowledge additional material for this relative risks (RRs). paper are available online. To of the clinical benefits and harms needs to be con- Intervention SGLT2 inhibitors, compared with placebo or view these files, please visit sidered before applying the results of this study. -
The Use of Sequential Pattern Mining to Predict Next Prescribed Medications ⇑ Aileen P
CORE Metadata, citation and similar papers at core.ac.uk Provided by Elsevier - Publisher Connector Journal of Biomedical Informatics 53 (2015) 73–80 Contents lists available at ScienceDirect Journal of Biomedical Informatics journal homepage: www.elsevier.com/locate/yjbin The use of sequential pattern mining to predict next prescribed medications ⇑ Aileen P. Wright a, , Adam T. Wright b, Allison B. McCoy c, Dean F. Sittig d a Yale School of Medicine, New Haven, CT, United States b Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, United States c Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States d The University of Texas School of Biomedical Informatics at Houston and the UT-Memorial Hermann Center for Healthcare Quality & Safety, Houston, TX, United States article info abstract Article history: Background: Therapy for certain medical conditions occurs in a stepwise fashion, where one medication Received 13 March 2014 is recommended as initial therapy and other medications follow. Sequential pattern mining is a data Accepted 8 September 2014 mining technique used to identify patterns of ordered events. Available online 16 September 2014 Objective: To determine whether sequential pattern mining is effective for identifying temporal relation- ships between medications and accurately predicting the next medication likely to be prescribed for a Keywords: patient. Sequential pattern mining Design: We obtained claims data from Blue Cross Blue Shield of Texas for patients prescribed at least one Data mining diabetes medication between 2008 and 2011, and divided these into a training set (90% of patients) and Knowledge base Clinical decision support test set (10% of patients).