The Staggering True Cost of Diabetes by Amanda Nguyen, Phd and Katie Mui
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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. -
Insulin Aspart Sanofi, If It Is Coloured Or It Has Solid Pieces in It
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Insulin aspart Sanofi 100 units/ml solution for injection in vial Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). Insulin aspart Sanofi 100 units/ml solution for injection in vial Each vial contains 10 ml equivalent to 1,000 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Each cartridge contains 3 ml equivalent to 300 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. Each pre-filled pen delivers 1-80 units in steps of 1 unit. *produced in Escherichia coli by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 Posology and method of administration Posology The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. -
Management of Hyperglycaemia and Steroid (Glucocorticoid) Therapy
Management of Hyperglycaemia and Steroid (Glucocorticoid) Therapy October 2014 This document is coded JBDS 08 in the series of JBDS documents Other JBDS documents: Admissions avoidance and diabetes: guidance for clinical commissioning groups and clinical team; December 2013, JBDS 07 The management of the hyperosmolar hyperglycaemic state (HHS) in adults with diabetes; August 2012, JBDS 06 Glycaemic management during the inpatient enteral feeding of stroke patients with diabetes; June 2012, JBDS 05 Self-management of diabetes in hospital; March 2012, JBDS 04 Management of adults with diabetes undergoing surgery and elective procedures: improving standards; April 2011, JBDS 03 The Management of Diabetic Ketoacidosis in Adults; revised September 2013, JBDS 02 The hospital management of hypoglycaemia in adults with diabetes mellitus; revised September 2013, JBDS 01 These documents are available to download from: ABCD website: www.diabetologists-abcd.org.uk/JBDS/JBDS.htm Diabetes UK website: www.diabetes.org.uk Contents Page Foreword 4 Authorship and acknowledgments 5-6 Introduction 7 Steroids - mechanism of action 8 Steroid therapy – impact on blood glucose 9 Glucose targets 10 Glucose monitoring 11 Diabetes treatment options 12-13 Treatment of steroid induced hyperglycaemia 14-15 Hospital discharge 16-17 Steroid treatment in pregnancy 18 Steroid treatment in end of life 19 Audit standards 20 Controversial areas 21 References 22 Appendix 1 – Algorithm to show treatment of steroid 23 induced diabetes Appendix 2 – Algorithm to show management of patients 24 with diabetes on once daily steroids Appendix 3 – End of life steroid management 25 Appendix 4 – Patient letter – Glucose monitoring and 26 steroid use 3 Foreword This is the latest in the series of Joint British Diabetes Societies for Inpatient Care (JBDS-IP) guidelines, and focuses on steroid induced hyperglycaemia and steroid induced diabetes. -
OZEMPIC (Semaglutide) Injection, for Subcutaneous Use Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙CONTRAINDICATIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ These highlights do not include all the information needed to use Personal or family history of medullary thyroid carcinoma or in patients OZEMPIC® safely and effectively. See full prescribing information with Multiple Endocrine Neoplasia syndrome type 2 (4). for OZEMPIC. Known hypersensitivity to OZEMPIC or any of the product components (4). OZEMPIC (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙WARNINGS AND PRECAUTIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Pancreatitis: Has been reported in clinical trials. Discontinue promptly if WARNING: RISK OF THYROID C-CELL TUMORS pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2). See full prescribing information for complete boxed warning. Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored (5.3). In rodents, semaglutide causes thyroid C-cell tumors. It is Never share an OZEMPIC pen between patients, even if the needle is unknown whether OZEMPIC causes thyroid C-cell tumors, changed (5.4). including medullary thyroid carcinoma (MTC), in humans as Hypoglycemia: When OZEMPIC is used with an insulin secretagogue or the human relevance of semaglutide-induced rodent thyroid C- insulin, consider lowering the dose of the secretagogue or insulin to reduce cell tumors has not been determined (5.1, 13.1). the risk of hypoglycemia (5.5). OZEMPIC is contraindicated in patients with a personal or Acute Kidney Injury: Monitor renal function in patients with renal family history of MTC or in patients with Multiple Endocrine impairment reporting severe adverse gastrointestinal reactions (5.6). Neoplasia syndrome type 2 (MEN 2). -
Diabetes Medication Reference for Clinicians This Table Provides Clinicians a Brief Overview of Examples of Medications Used to Treat Diabetes
Diabetes Medication Reference for Clinicians This table provides clinicians a brief overview of examples of medications used to treat diabetes. This is not a complete list and is not intended to be used as a sole reference. Nursing responsibilities with ALL diabetes medications: Emphasize importance of self-monitoring of blood glucose (SMBG); teach to be aware of signs/symptoms of allergic reactions; teach to be aware of possible side effects and contraindications; and monitor A1C levels. Oral Medication Action Possible Side-effects Contraindications Nursing Responsibilities Biguanide • Lowers glucose levels • Anorexia, nausea, • Renal disease Patient education: • metformin by decreasing the vomiting, diarrhea - • Liver failure or • Take with food (Glucophage, amount of glucose usually occurs during alcohol abuse (can • Keep appointments Glucophage XR, produced by the liver initiation of the drug result in lactic for regular kidney Glumetza, Fortamet, • Increases glucose • Vitamin B-12 acidosis) function lab tests Riomet) uptake in muscle deficiency • Temporarily held on • Avoid alcohol • Multiple combinations cells • Lactic acidosis day of procedures • Report abnormal with other classes • Improves (severe but rare) with dye and glucose levels • First line therapy for hyperglycemia & • Should not cause withheld 48 hours • Report s/s lactic type 2 diabetes; hypertriglyceridemia hypoglycemia as after the procedure; acidosis (weakness, current in obese patients monotherapy restart after drowsiness, malaise) recommendation is to with diabetes; may confirmation of renal start upon diagnosis promote weight loss function This material was prepared by Quality Insights, the Medicare Quality Innovation Network-Quality Improvement Organization supporting the Home Health Quality Improvement National 1 Campaign, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. -
What You Need to Know: Centers for Medicare & Medicaid Services Part D Measure — Statin Use in Persons with Diabetes
T:8.5” What You Need to Know: Centers for Medicare & Medicaid Services Part D Measure — Statin Use in Persons With Diabetes UnitedHealthcare recognizes the time and effort you put into managing the health of your patients with diabetes. To help you be as efficient as possible, we’re offering this guide with detailed information about the Statin Use in Persons With Diabetes (SUPD) Part D measure from the Centers for Medicare & Medicaid Services (CMS). Defining the SUPD measure CMS defines this measure as the percentage of Medicare members with diabetes ages 40–75 who receive at least one fill of a statin medication in the measurement year. Members with diabetes are defined as those who have at least two fills of diabetes medications during the measurement year. Only pharmacy claims are used to identify and close care opportunities for this measure. Members who have end-stage renal disease (ESRD) and/or are in hospice care are excluded from the SUPD measure. Understanding measure rationale The SUPD measure is based on cholesterol guidelines from the American College of Cardiology/American Heart T:11” Association (ACC/AHA). The guidelines recommend moderate- to high-intensity statin therapy for patients ages 40–75 with diabetes to help prevent atherosclerotic cardiovascular disease (ASCVD).1,2 The guidelines: • Recognize patients ages 40–75 with diabetes are at a substantially higher lifetime risk for ASCVD events and experience greater morbidity and worse survival rates following the start of clinical ASCVD. • Indicate statins have been shown to be effective in reducing the risk for cardiovascular events. • Align with the American Diabetes Association in recommending statin therapy for patients ages 40–75 with diabetes to help prevent ASCVD.3 Reaching the SUPD target goal To successfully meet CMS requirements, men and women who fit the measure definition must be on a statin medication for the prevention of ASCVD, if clinically appropriate. -
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. -
Insulin Aspart (Nvolog): Important Patient Information
What is most important to remember? If you have questions: Strong Internal Medicine • Insulin aspart (Novolog®) is used to lower blood sugar. It is Ask your doctor, nurse or pharmacist for important to use this medicine as more information about insulin aspart directed by your doctor (Novolog®) • Do not start any new medicines, over-the-counter drugs or herbal remedies without talking to your doctor • Tell all doctors, dentists and pharmacists that you are using insulin aspart (Novolog®) • insulin aspart (Novolog®) can cause low blood sugar. Always Strong Internal Medicine keep a source of sugar handy for 601 Elmwood Avenue times when your blood sugar gets Ambulatory Care Facility, 5th Floor too low Rochester, NY 14642 Phone: (585) 275 -7424 Insulin Aspart • Do not use your insulin if it (Novolog®): Visit our website at: becomes cloudy or has particles www.urmc.rochester.edu/medicine/ - Important Patient Information in it general-medicine/patientcare/ • Throw away all opened insulin after 28 days, even if it is not used up What does insulin aspart (Novolog®) do? Are there any interactions with other drugs that I need What are some things that I need to be aware of when to worry about? taking insulin aspart (Novolog®)? • It is used to lower blood sugar in patient with high blood sugar (diabetes) • There are many drug interactions that may increase • Tell your doctor or pharmacist if you have an allergy to How should insulin aspart (Novolog®) be used? your risk of side effects insulin, or any other drugs, foods, or substances • Use this -
Safety of Insulin Lispro and a Biosimilar Insulin Lispro When
DSTXXX10.1177/1932296817753644Journal of Diabetes Science and TechnologyThrasher et al 753644research-article2018 Original Article Journal of Diabetes Science and Technology 2018, Vol. 12(3) 680 –686 Safety of Insulin Lispro and a Biosimilar © 2018 Diabetes Technology Society Insulin Lispro When Administered Reprints and permissions: sagepub.com/journalsPermissions.nav Through an Insulin Pump DOI:https://doi.org/10.1177/1932296817753644 10.1177/1932296817753644 journals.sagepub.com/home/dst James Thrasher, MD1, Howard Surks, MD2, Irene Nowotny, PhD3, Suzanne Pierre, MSc4, Baerbel Rotthaeuser, PhD3, Karin Wernicke-Panten, MD3, and Satish Garg, MD5 Abstract Background: SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps). Methods: This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510). The main outcome was the incidence of infusion set occlusions (ISOs), defined as failure to correct hyperglycemia (plasma glucose ≥≥ 300 mg/dl) by 50 mg/dl within 60 minutes by insulin bolus via the pump. Secondary outcomes included intervals between infusion set changes, treatment-emergent adverse events (TEAEs) including infusion site, hypersensitivity reactions and hypoglycemic events, and safety. Results: The number of patients reporting at least one ISO was small: 6/25 patients on SAR-Lis reported 14 ISOs and 4/27 on Ly-Lis reported nine ISOs. The estimated difference in ISO risk for SAR-Lis versus Ly-Lis was 7.9% (95% CI, –1.90 to 17.73). -
Insulin Products and the Cost of Diabetes Treatment
November 19, 2018 Insulin Products and the Cost of Diabetes Treatment Insulin is a hormone that regulates the storage and use of would involve a consistent insulin level between meals sugar (glucose) by cells in the body. When the pancreas combined with a mealtime level of insulin that has a rapid does not make enough insulin (type 1 diabetes) or it cannot onset and duration of action to match the glucose peak that be used effectively (type 2 diabetes), sugar builds up in the occurs after a meal. The original insulin, also called regular blood. This may lead to serious complications, such as heart insulin, is a short-acting type of product with a duration of disease, stroke, blindness, kidney failure, amputation of action of about 8 hours, making it less suitable for toes, feet, or limbs. Prior to the discovery of insulin providing 24-hour coverage. treatment, type 1 diabetics usually died from this disease. In the late 1930s through the 1950s, regular insulin was There were 23.1 million diagnosed cases of diabetes in the altered by adding substances (protamine and zinc) to gain United States in 2015 according to the Centers for Disease longer action; these are called intermediate-acting insulins. Control and Prevention (CDC). Adding an estimated 7.2 One such advance (neutral protamine Hagedorn, or NPH) million undiagnosed cases brings the total to 30.3 million was patented in 1946 and is still in use today. It allowed for (9.4% of U.S. population). People with type 1 diabetes, the combination of two types of insulin in premixed vials about 5% of U.S. -
Insulin Glargine (HOE901) First Responsibilities: Understanding the Data and Ensuring Safety
EDITORIAL Insulin Glargine (HOE901) First responsibilities: understanding the data and ensuring safety n this issue, Heinemann et al. (1) and Rat- decline in activity through the duration of other journals. They leave the reader with ner et al. (2) provide the results of stud- the 30-h study. The authors conclude that a sense of promise, but without the firm Iies of insulin glargine (formerly known as insulin glargine provides a flatter metabolic conviction that insulin glargine is clearly HOE901), the most recent addition to the profile than NPH insulin. Theoretically, this superior to other long-acting forms of growing family of insulin analogs and for- could prove to be advantageous in accom- insulin. The pharmacodynamic study sug- mulations. The authors report insulin modating the basal insulin requirements of gests that the peakless profile of action glargine’s pharmacodynamic characteristics patients with diabetes. should provide an advantage that can be (1) and data concerning its safety and effi- Ratner et al. (2) report initial results for used to produce clinically meaningful cacy when administered to subjects with the U.S. Study Group of Insulin Glargine in improvements in glycemic control. The type 1 diabetes who were treated with reg- Type 1 Diabetes. In their article, they clinical trial’s demonstration of a reduction ular insulin (2). Insulin glargine is produced describe the results of a large randomized in hypoglycemia and in fasting plasma glu- by recombinant DNA technology with 2 prospective 28-week trial of insulin cose levels appears to provide an opportu- modifications of the native human insulin glargine versus NPH insulin. -
Antidepressant Prescription Practices Among Primary Health Care Providers for Patients with Diabetes Mellitus
Research Article Curre Res Diabetes & Obes J Volume 2 Issue 4 - June 2017 Copyright © All rights are reserved by Gillian Bartlet DOI: 10.19080/CRDOJ.2017.2.555593 Antidepressant Prescription Practices among Primary Health Care Providers for Patients with Diabetes Mellitus Gagnon J, Lussier MT, Daskalopoulou SS, MacGibbon B, Bartlett G 1Department of Family Medicine, McGill University, Canada 2Department of Family Medicine and Emergency Medicine, Université de Montréal, Canada 3Department of Medicine, McGill University, Canada 4Department of Mathematics, Université du Québec à Montréal, Canada 5Department of Family Medicine, McGill University, Canada Submission: June 13, 2017; Published: June 27, 2017 *Corresponding author: Gillian Bartlett, Department of Family Medicine, McGill University, Canada, Tel: ; Fax: ; Email: Abstract Purpose: Depression is a common comorbidity in people with diabetes that increases the risk of poor diabetes control and diabetes- related complications. While treatment of depression is expected to help, some antidepressants have been associated with impaired glucose metabolism. Evidence is lacking in the scope of this problem for people with diabetes. The objective of this study is to describe the prescription of antidepressants for diabetic patients with a focus on medications suspected to impair glucose control. Methods: A cross-sectional study of electronic medical record data from 115 primary care practices in the Canadian Primary Care Sentinel Surveillance Network was conducted. Descriptive statistics were used to describe the prescription of antidepressants for people with diabetes between 2009 and 2014. Results: From the sample, 17,258 diabetic patients were prescribed at least one antidepressant (AD) between 2009 and 2014. In terms of pharmacological class, the greatest proportion of people were prescribed selective serotonin reuptake inhibitors (46.2%), followed by serotonin-norepinephrine reuptake inhibitors (24.3%) and tricyclic antidepressants (23.8%).