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Evidenz Und Versorgungsrealität Von Kurzwirksamen Insulinanaloga in Der Behandlung Des Typ-2-Diabetes Mellitus
Evidenz und Versorgungsrealität von kurzwirksamen Insulinanaloga in der Behandlung des Typ-2-Diabetes mellitus – Eine Versorgungsanalyse auf der Basis von Sekundärdaten – Dissertation zur Erlangung des Doktorgrades der Naturwissenschaften vorgelegt beim Fachbereich 14 - Biochemie, Chemie und Pharmazie der Johann Wolfgang Goethe-Universität in Frankfurt am Main von Matthias S. Pfannkuche aus Brühl Frankfurt am Main, im Jahr 2009 vom Fachbereich 14 - Biochemie, Chemie und Pharmazie der Johann Wolfgang Goethe-Universität als Dissertation angenommen. Dekan: Prof. Dr. rer. nat. Dieter Steinhilber Gutachter: Prof. Dr. rer. nat. Theo Dingermann Prof. Dr. rer. nat. Gerd Glaeske (Universität Bremen) Datum der Disputation: 15. Februar 2010 Bildnachweis Titelseite: Insulin Hexamer: http://commons.wikimedia.org/wiki/File:Human-insulin-hexamer-3D-ribbons.png (letzter Zugriff: 11.06.2009) Non semper ea sunt, quae videntur. (Phädrus, fabulae 4, 2, 5) Danksagung Diese Dissertation sowie die hiermit in Verbindung stehenden Publikationen wären ohne die Anregungen und Unterstützung durch viele Kollegen, Freunde und Organisationen nicht möglich gewesen. Ihnen möchte ich an dieser Stelle danken. Mein besonderer Dank gilt Prof. Dr. rer. nat Gerd Glaeske und Prof. Dr. rer. nat. Theo Dingermann, die diese Arbeit in vielerlei Hinsicht erst ermöglichten. Überaus dankbar bin ich Prof. Dr. rer. nat. Gerd Glaeske für die freundliche Aufnahme in seine Arbeitsgruppe, die es mir ermöglichte weitere Einblicke in die Gesundheitsökonomie, Gesundheitspolitik und Versorgungsforschung zu nehmen. Für das Korrekturlesen der kompletten Arbeit, die zahlreichen Hinweise und konstruktiven Diskussionen sowie die zahlreichen Mittagspausen danke ich im besonderen Dr. P.H. Falk Hoffmann. Herzlicher Dank gilt auch dem gesamten Arbeitskreis in Bremen sowie den Projektbeteiligten Krankenkassen, allen voran der GEK, die mir durch den Zugriff auf ihre Daten erst viele Analysen ermöglichten. -
LANTUS® (Insulin Glargine [Rdna Origin] Injection)
Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. -
Combining a Glucagon-Like Peptide-1 Receptor Agonist with Basal Insulin: the Why and How
Combining a Glucagon-like Peptide-1 Receptor Agonist with Basal Insulin: The Why and How Case Study Mary is a 61 year-old female diagnosed with type 2 diabetes mellitus (T2DM) 8 years ago. She was initially managed with the combination of lifestyle modification and metformin. Since that time she was treated with a sulfonylurea, but it was discontinued due to symptomatic hypoglycemia. She was also treated with pioglitazone, but significant fluid retention led to it discontinuation. A year-and-a- half ago, basal insulin was added to her lifestyle and metformin management. She now administers 52 units (0.62 units/kg) once daily at bedtime. Since starting basal insulin, she has experienced 3 episodes of mild hypoglycemia. Since her diagnosis, Mary’s HbA1c has never been <7.0%; her current HbA1c is 7.9%. Over the past month, her fasting plasma glucose (FPG) has ranged from 103 mg/dL to 136 mg/dL and her postprandial glucose (PPG) from 164 mg/dL to 213 mg/dL. She has gained 2.6 kg since starting basal insulin and her body mass index is now 31 kg/m2. Her blood pressure is 134/82 mmHg. She experiences occasional tingling in her feet. Eye examination reveals grade 1 retinopathy. Current medications are: metformin 1000mg twice daily, basal insulin 52 units once daily at bedtime, and hydrochlorothiazide 25 mg once daily. Her family physician notes that Mary’s FPG is reasonably well-controlled, yet her HbA1c and PPG remain elevated. He is also concerned about her episodes of hypoglycemia and weight gain and the evidence indicating microvascular damage. -
Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba
Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba by Kim¡ T. G. Guilbert A Thesis submitted to The Faculty of Graduate Studies in Partial Fulfillment of the Requirements for the Degree of MASTER OF SCIENCE Faculty of Pharmacy The University of Manitoba Winnipeg, Manitoba @ Kimi T.G. Guilbert, March 2005 TIIE UMYERSITY OF MANITOBA F'ACULTY OF GRADUATE STTJDIES +g+ù+ COPYRIGIIT PERMISSION PAGE Diabetes Mellitus: Patterns of Pharmaceutical Use in Manitoba BY Kimi T.G. Guilbert A ThesisÆracticum submitted to the Faculty of Graduate Studies of The University of Manitoba in partial fulfillment of the requirements of the degree of MASTER OF SCIENCE KIMI T.G. GTIILBERT O2()O5 Permission has been granted to the Library of The University of Manitoba to lend or sell copies of this thesis/practicum, to the National Library of Canada to microfïlm this thesis and to lend or sell copies of the film, and to University Microfilm Inc. to publish an abstract of this thesis/practicum. The author reserves other publication rights, and neither this thesis/practicum nor extensive extracts from it may be printed or otherwise reproduced without the author's written permission. Acknowledgements Upon initiation of this project I had a clear objective in mind--to learn more. As with many endeavors in life that are worthwhile, the path I have followed has brought me many places I did not anticipate at the beginning of my journey. ln reaching the end, it is without a doubt that I did learn more, and the knowledge I have been able to take with me includes a wider spectrum than the topic of population health and medication utilization. -
A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D
Drugs 2005; 65 (3): 325-340 REVIEW ARTICLE 0012-6667/05/0003-0325/$39.95/0 2005 Adis Data Information BV. All rights reserved. A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D. Mooradian Division of Endocrinology, Department of Internal Medicine, Diabetes, and Metabolism, St Louis University School of Medicine, St Louis, Missouri, USA Contents Abstract ....................................................................................325 1. Physiology of Insulin Secretion .............................................................326 2. Conventional Insulin Preparations ..........................................................327 3. Insulin Analogues ........................................................................328 3.1 Rapid-Acting Insulin Analogues .......................................................328 3.1.1 Insulin Lispro ...................................................................328 3.1.2 Insulin Aspart ..................................................................329 3.1.3 Insulin Glulisine .................................................................329 3.1.4 Clinical Utility of Rapid-Acting Insulin Analogues ...................................330 3.2 Premixed Insulins and Insulin Analogues ................................................331 3.3 Basal Insulin Analogues ...............................................................331 3.3.1 Insulin Glargine ................................................................331 -
Type 3 Diabetes and Its Role Implications in Alzheimer's Disease
International Journal of Molecular Sciences Review Type 3 Diabetes and Its Role Implications in Alzheimer’s Disease 1, 2, 3 Thuy Trang Nguyen y, Qui Thanh Hoai Ta y, Thi Kim Oanh Nguyen , Thi Thuy Dung Nguyen 4,* and Vo Van Giau 5,6,* 1 Faculty of Pharmacy, Ho Chi Minh City University of Technology (HUTECH), Ho Chi Minh City 700000, Vietnam; [email protected] 2 Institute of Research and Development, Duy Tan University, Danang 550000, Vietnam; [email protected] 3 Faculty of Food Science and Technology, Ho Chi Minh City University of Food Industry, Ho Chi Minh City 700000, Vietnam; oanhntk@hufi.edu.vn 4 Faculty of Environmental and Food Engineering, Nguyen Tat Thanh University, Ho Chi Minh City 700000, Vietnam 5 Graduate School of Environment Department of Industrial and Environmental Engineering, Gachon University, 1342 Sungnam-daero, Sujung-gu, Seongnam-si, Gyeonggi-do 461-701, Korea 6 Department of Bionano Technology, Gachon Medical Research Institute, Gachon University, 1342 Sungnam-daero, Sujung-gu, Seongnam-si, Gyeonggi-do 461-701, Korea * Correspondence: [email protected] (T.T.D.N.); [email protected] (V.V.G.) These authors contributed equally to this work. y Received: 12 April 2020; Accepted: 28 April 2020; Published: 30 April 2020 Abstract: The exact connection between Alzheimer’s disease (AD) and type 2 diabetes is still in debate. However, poorly controlled blood sugar may increase the risk of developing Alzheimer’s. This relationship is so strong that some have called Alzheimer’s “diabetes of the brain” or “type 3 diabetes (T3D)”. Given more recent studies continue to indicate evidence linking T3D with AD, this review aims to demonstrate the relationship between T3D and AD based on the fact that both the processing of amyloid-β (Aβ) precursor protein toxicity and the clearance of Aβ are attributed to impaired insulin signaling, and that insulin resistance mediates the dysregulation of bioenergetics and progress to AD. -
Performance of the Insulin-Only Ilet Bionic Pancreas and The
e118 Diabetes Care Volume 44, June 2021 Performance of the Insulin-Only Luz E. Castellanos,1 Courtney A. Balliro,1 Jordan S. Sherwood,1 Rabab Jafri,1 iLet Bionic Pancreas and the Mallory A. Hillard,1 Evelyn Greaux,1 Rajendranath Selagamsetty,2 Hui Zheng,3 Bihormonal iLet Using Firas H. El-Khatib,2 Edward R. Damiano,2,4 and Dasiglucagon in Adults With Type Steven J. Russell1 1 Diabetes in a Home-Use Setting Diabetes Care 2021;44:e118–e120 | https://doi.org/10.2337/dc20-1086 Reductions in blood glucose levels in with insulin lispro (Eli Lilly) or aspart (Table 1). The mean CGM glucose and people with diabetes are often achieved (Novo Nordisk), the bihormonal iLet for time in range (70–180 mg/dL) were 149 at the expense of increased hypoglyce- 7dayswithdasiglucagon(4mg/mL) ±13mg/dLand72±8%,respectively,in mia. A novel approach is to automati- and insulin lispro or aspart, or both, us- the insulin-only period, and 139 ± 11 cally deliver microdose glucagon when ing the same glucose target (110 mg/ mg/dL and 79 ± 9%, respectively, in the automation of insulin delivery alone is dL), in random order. There were no re- bihormonal period. The mean daily car- not sufficient to prevent hypoglycemia. strictions on diet or exercise. The prima- bohydrates consumed to prevent or The approach requires a bihormonal de- ry outcomes were prespecified iLet treat hypoglycemia were 16 ± 13 g and vice and a stable form of glucagon or operational thresholds. The key second- 18 ± 21 g in the insulin-only and bihor- glucagon analog. -
Diabetes and Dementia Mario Barbagallo* and Ligia J
Barbagallo and Dominguez. Int J Diabetes Clin Res 2015, 2:4 ISSN: 2377-3634 International Journal of Diabetes and Clinical Research Commentary: Open Access Diabetes and Dementia Mario Barbagallo* and Ligia J. Dominguez Geriatric Unit, Department DIBIMIS, University of Palermo, Italy *Corresponding author: Mario Barbagallo, UOC di Geriatria e Lungodegenza, AOUP Azienda Universitaria Policlinico, University of Palermo, Italy, Tel: +390916552885, Fax: +390916552952, E-mail: [email protected] speed and executive functions [13,14]. Not only frank dementia, Abstract but also mild cognitive impairment (MCI) is associated with DM2, Persons with type 2 diabetes mellitus (DM2) have an increased as well as an accelerated progression from MCI to dementia [15]. incidence of cognitive decline and dementia. An increased cortical Dementia is the most common comorbidity in persons with diabetes and subcortical atrophy has been found after controlling for in nursing homes [16]. vascular disease and inadequate cerebral circulation. A possible role of insulin resistance and hyperinsulinemia has been suggested Several studies on the cerebral structure of patients with diabetes to mediate the link between DM2 and Alzheimer’s Disease (AD). have evidenced increased cortical and subcortical atrophy (besides Altered insulin signaling may contribute to AD biochemical and increased leukoaraiosis and cerebrovascular disease), which were histopathological lesions. Both hyperglycemia and hypoglycemia associated with impaired cognitive performance [17,18]. Insulin may contribute to cognitive decline in DM2. Recurrent symptomatic and asymptomatic hypoglycemic episodes have been suggested itself and insulin resistance have been suggested as mediators of to cause subclinical brain damage, and permanent cognitive AD-type neurodegeneration. It has been proposed that AD may be impairment. -
IHS PROVIDER September 2017
September 2017 Volume 42 Number 9 Indian Health Service National Pharmacy and Therapeutics Committee SGLT-2 inhibitors (Update) NPTC Formulary Brief August Meeting 2017 Background: The FDA has currently approved three SGLT-2 inhibitors, two of which have completed FDA-mandated cardiovascular outcomes trials. Last year, in the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG), empagliflozin not only reduced cardiovascular events, but also mortality.1 This year, the Canagliflozin Cardiovascular Assessment Study (CANVAS) demonstrated equivocal cardiovascular benefits, no mortality benefit, and significant harms in those receiving canagliflozin.2 The DECLARE-TIMI 58 cardiovascular study of dapagliflozin will be completed in April 2019 (ClinicalTrials.gov Identifier: NCT01730534). Uncertainty remains regarding the current data, long- term benefits and harms, and differentiation among SGLT-2 inhibitors. Following a review of SGLT2 inhibitors at the August 2017 NPTC meeting on their cardiovascular outcomes, net benefit and place in therapy, no modifications were made to the National Core Formulary (NCF). Discussion: EMPA-REG enrolled 7,020 patients with Type 2 diabetes mellitus (T2DM) and HgbA1c values between 7.0-10.0%. All patients had established cardiovascular disease (CVD) and were observed for a median duration of 3.1 years. Empagliflozin reduced the primary outcome of cardiovascular (CV) death, nonfatal myocardial infarction (MI), or nonfatal cardiovascular accident (CVA) by 6.5 events per 1000 patient-years (pt-yrs). Mortality decreased by 9.2 events per 1000 pt-yrs, primarily driven by a reduction in CV mortality of 7.8 events per 1000 pt-yrs. Heart failure hospitalization decreased by 5.1 events per 1000 pt-yrs. -
Clinical Practice Guideline for Diagnosis, Treatment and Follow-Up of Diabetes Mellitus and Its Complications - 2019
THE SOCIETY of ENDOCRINOLOGY and METABOLISM of TURKEY (SEMT) Clinical Practice Guideline for Diagnosis, Treatment and Follow-up of Diabetes Mellitus and Its Complications - 2019 English Version of the 12th Edition SEMT Diabetes Mellitus Working Group ISBN: 978-605-4011-39-1 CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS, TREATMENT, AND FOLLOW-UP OF DIABETES MELLITUS AND ITS COMPLICATIONS-2019 © SEMT -2019 This material has been published and distributed by The Society of Endocrinology and Metabolism of Turkey (SEMT). Whole or part of this guideline cannot be reproduced or used for commercial purposes without permission. THE SOCIETY of ENDOCRINOLOGY and METABOLISM of TURKEY (SEMT) Meşrutiyet Cad., Ali Bey Apt. 29/12, Kızılay 06420, Ankara, Turkey Phone. +90 312 425 2072 http://www.temd.org.tr ISBN: 978-605-4011-39-1 English Version of the 12th Edition Publishing Services BAYT Bilimsel Araştırmalar Basın Yayın ve Tanıtım Ltd. Şti. Ziya Gökalp Cad. 30/31 Kızılay 06420, Ankara, Turkey Phone. +90 312 431 3062 Fax +90 312 431 3602 www.bayt.com.tr Printing Miki Matbaacılık San. ve Tic. Ltd. Şti. Matbaacılar Sanayi Sitesi 1516/1 Sk. No. 27 İvedik, Yenimahalle / Ankara, Turkey Phone. +90 312 395 2128 Print Date: October 23, 2019 “Major achievements and important undertakings are only possible through collaborations” “Büyük işler, mühim teşebbüsler; ancak, müşterek mesai ile kabil-i temindir.” MUSTAFA KEMAL ATATÜRK, 1925 PREFACE Dear colleagues, The prevalence of diabetes has been increasing tremendously in the last few decades. As a result , medical professionals/ specialists from different fields encounter many diabetics in their daily practice. At this point, updated guidelines on diabetes management, which take regional specification into consideration is needed. -
Diabetes and Health
Diabetes and Health Diabetes Prevention and Control Program Population and Community Health Bureau Public Health Division NM Department of Health Jill Joseph, Nurse Consultant May 21, 2021 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org • Jill Joseph BSN • Nurse Consultant, Diabetes Prevention and Control Program • [email protected] • (505) 476-7618 • There are no conflicts of interest to disclose 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org Today’s Discussion • Introduction • Diabetes Basics • Diabetes defined • Common forms • Uncommon forms • Risk Factors/Complications • Management • Prevention • Questions 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org New Mexico Department of Health Diabetes Prevention and Control Program • Prevent or delay diabetes • Prevent complications, disabilities, and burden associated with diabetes and related chronic conditions • Advance health equity to improve health outcomes and quality of life among all New Mexicans. 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org JJ1 Diabetes and Prediabetes Why talk about these? • Because of the numbers • Because diabetes has profound effects on our bodies 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org Slide 5 JJ1 Jill Joseph, 5/17/2021 Diabetes is: • A disorder of the body’s ability to process food for energy use. The food we eat is turned into glucose, or sugar, for our bodies to use for energy. -
Type 2 Diabetes Adult Outpatient Insulin Guidelines
Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal.