Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief

Size: px
Start display at page:

Download "Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief"

Transcription

1 Second- and Third-Line Approaches for Type 2 Diabetes Workgroup: Topic Brief March 7, 2016 Session Objective: The objective of this workshop is to assess the value of undertaking comparative effectiveness studies incorporating newer agents for treating patients with type 2 diabetes mellitus, with a focus on SGLT-2 inhibitors, DPP-4 inhibitors, and other agents, and to define the parameters for such research. This document was prepared for informational purposes only and should not be construed as medical advice or used for clinical decision making.

2 Opportunity Snapshot As part of PCORI s efforts to fund high-impact and useful research on critical patient-centered health and healthcare issues, the Clinical Effectiveness Research (CER) program is hosting a multi-stakeholder workgroup to discuss secondand third-line therapies for type 2 diabetes. The objective of this workshop is to assess the value of undertaking comparative effectiveness studies incorporating newer agents for treating patients with type 2 diabetes mellitus, with a focus on sodium glucose cotransporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and other classes of agents. Potential parameters of comparative research in this area will also be discussed. The CER program intends to use the feedback from this workshop to determine whether an investment in patient-centered research in this area by PCORI could offer unique contributions. The following materials are largely excerpted from previous PCORI briefs. 1, 2 I. Background Diabetes affects over 29 million Americans and continues to increase in prevalence, with 1.7 million new cases in As the seventh leading cause of death in the United States, diabetes may decrease life expectancy by as much as 10 to 15 years. 3, 4 Beyond its impact on mortality, diabetes is a significant societal burden, with over $245 billion in annual costs. Much of this expense results from the devastating complications of diabetes, which include vision loss, kidney injury, lower extremity amputation, heart attacks, and strokes. Along with these complications, people with poorly controlled type 2 diabetes commonly experience decreased sense of well-being, impaired quality of life, cognitive impairment, depression, periodontal disease, and other effects. 5 Treatment of type 2 diabetes typically begins with lifestyle modification and the prescription of metformin, a medication that lowers blood sugar by reducing glucose production in the liver and enhancing muscle glucose uptake. When lifestyle modification and metformin are insufficient to control blood sugar, additional medications are prescribed. The Surveillance Prevention and Management of Diabetes Mellitus (SUPREME-DM) study found that the addition of a second-line therapy is required in more than one-third (34 percent) of recently diagnosed type 2 diabetics within 6 months and in nearly half (45 percent) within 12 months. 6 Further intensification of treatment by adding a third antidiabetic agent may be required when glucose control is insufficient with dual therapy. While metformin is the consensus first-line pharmacologic treatment for type 2 diabetes, clinical guidelines provide less clarity regarding the choice of second- and third-line therapies. Numerous classes of drugs to treat type 2 diabetes exist, with varying benefits and risks associated with each class and further variance occurring between drugs in each class. These classes include: sulfonylureas, thiazolidinediones, DPP-4 inhibitors, SGLT-2 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and insulin

3 In their 2015 position statement on the management of hyperglycemia in type 2 diabetes, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes recommend that second- and third-line glucoselowering agents should be chosen from available options based on patient preferences as well as various patient, disease, and drug characteristics, but the position statement does not specify an order of preference among drug classes. 7 In contrast, while the 2016 consensus statement by the American Association of Clinical Endocrinologists and the American College of Endocrinology on the comprehensive type 2 diabetes management algorithm also recommends tailoring the choice of therapies to patient preferences and needs, these recommendations suggest a hierarchy of usage for second-line treatments placing GLP-1 receptor agonists at the top of the list, followed by SGLT-2 inhibitors, DPP-4 inhibitors, and a number of other classes of drugs. 8 The lack of clarity within and among existing guidelines and recommendations and the number of drug classes available make the selection of the appropriate second- and thirdline therapies a challenge for patients and clinicians. II. Current Research and Evidence Base Ongoing comparative effectiveness studies may help to inform the choice of second- and third-line pharmacologic agents for type 2 diabetes. Chief among these studies is the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study. GRADE is a multicenter pragmatic trial designed to compare four medications commonly added to metformin: 1) glimepride (a sulfonylurea); 2) sitagliptin (a DDP-4 inhibitor); 3) liraglutide (a GLP-1 receptor agonist); and 4) glargine (long-acting insulin). The GRADE study s primary outcome is time to treatment failure, which is defined as hemoglobin A1c 7% during the anticipated five-year observation period. Secondary outcomes include microvascular complications, adverse effects, tolerability, quality of life, and cost-effectiveness. Estimated enrollment is 5,000 participants, and study follow-up is expected to conclude in Of note, GRADE does not include SGLT-2 inhibitors, as this newest class of drugs was not on the market at the time the GRADE study was planned. In the past three years, the FDA has approved three SGLT-2 inhibitors: canagliflozin, dapagliflozin, and empagliflozin. 10 The introduction of the SGLT-2 inhibitor class to the market is of therapeutic interest as the class functions by inhibiting renal reabsorption of glucose and increasing excretion of glucose in the urine. Accordingly, SGLT-2 inhibitors function independent of insulin production and regulation and may be used at any stage of type 2 diabetes and in combination with other type 2 diabetes medications. In addition, they introduce the potential advantage of modest weight loss and the lowering of blood pressure. 7, 10, 11 In late 2015, the findings of the EMPA-REG OUTCOME trial were published indicating that emplagliflozin is beneficial for patients with type 2 diabetes at high risk for cardiovascular events. 12 Trials evaluating cardiovascular outcomes among high-risk patients on canagliflozin and 13, 14 dapagliflozin are ongoing with findings anticipated in 2017 and 2019, respectively. 3

4 III. Research Areas of Interest Given that: 1) the prevalence, morbidity, and costs of type 2 diabetes are increasing; 2) the comparative effectiveness of available second- and third-line medication for type 2 diabetes remains uncertain; and 3) GRADE will likely not conclude before 2020 and will not include all potentially relevant medication classes (namely, SGLT-2 inhibitors), further research comparing the effectiveness of second- and third-line therapies for type 2 diabetes will likely be informative. PCORI is interested in potentially funding comparative effectiveness research that would: Complement and expand on existing and ongoing comparative effectiveness trials assessing second-line type 2 diabetes treatments; Include newly approved second-line type 2 diabetes treatments not currently included as a comparator in clinical effectiveness trials (i.e., SGLT-2 inhibitors); and Evaluate outcomes identified important by patients, clinicians, and other stakeholders. References 1. Crowley MJ, Coeytaux RR, Myers ER, et al. Future research prioritization: comparative effectiveness of second- and third-line 4

5 therapies for treatment of type 2 diabetes. Duke Evidence Synthesis Group for PCORI. July Duke Evidence Synthesis Group for PCORI. Comparative Effectiveness of second-line therapies after failed metformin use (sulfonylureas, meglitinides, thiazolidinediones, acarbose, incretin agents, etc.) in type 2 diabetes treatment. May Centers for Disease Control and Prevention. National diabetes statistics report: Estimates of diabetes and its burden in the United States, Atlanta, GA: U.S. Department of Health and Human Services; Colagiuri S. Epidemiology of prediabetes. The Medical Clinics of North America. Mar 2011;95(2): , vii. 5. American Diabetes Association. Economic Costs of Diabetes in the U.S. in American Diabetes Association. Diabetes Care. 2013;36: Raebel MA, Ellis JL, Schroeder EB, et al. Intensification of antihyperglycemic therapy among patients with incident diabetes: a Surveillance Prevention and Management of Diabetes Mellitus (SUPREME-DM) study. Pharmacoepidemiology and Drug Safety. 2014;23(7): Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: A patient centered approach Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38: Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm 2016 executive summary. Endocrine Practice. 2016;22(1): Nathan DM, Buse JM, Kahn SE, et al. Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE). Diabetes Care. 2013; Vivian EM. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors: a growing class of antidiabetic agents. Drugs in Context. 2014; Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes A systematic review and meta-analysis. Ann Intern Med. 2013; 159: Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine. 2015;373(22): Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS) a randomized placebo-controlled trial. Am Heart J. 2013;166: Multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events (DECLARE-TIMI58). NCT Accessed at https://clinicaltrials.gov/ct2/show/nct on 5 February

trends in the treatment of Diabetes type 2 - New classes of antidiabetic drugs. IAIM, 2015; 2(4): 223-

trends in the treatment of Diabetes type 2 - New classes of antidiabetic drugs. IAIM, 2015; 2(4): 223- Review Article Pharmacological trends in the treatment of Diabetes type 2 - New classes of antidiabetic Silvia Mihailova 1*, Antoaneta Tsvetkova 1, Anna Todorova 2 1 Assistant Pharmacist, Education and

More information

CASE B1. Newly Diagnosed T2DM in Patient with Prior MI

CASE B1. Newly Diagnosed T2DM in Patient with Prior MI Newly Diagnosed T2DM in Patient with Prior MI 1 Our case involves a gentleman with acute myocardial infarction who is newly discovered to have type 2 diabetes. 2 One question is whether anti-hyperglycemic

More information

CASE A1 Hypoglycemia in an Elderly T2DM Patient with Heart Failure

CASE A1 Hypoglycemia in an Elderly T2DM Patient with Heart Failure Hypoglycemia in an Elderly T2DM Patient with Heart Failure 1 I would like to introduce you to Sophie, an elderly patient with long-standing type 2 diabetes, who has a history of heart failure, a common

More information

CDA CPG 2016 Interim Update. Preferences & access to treatment. Program Director Knowledge Translation & Optimizing Care Models

CDA CPG 2016 Interim Update. Preferences & access to treatment. Program Director Knowledge Translation & Optimizing Care Models Safety of New Antihyperglycemics in Patients with Cardiovascular Disease Lori MacCallum, BScPhm, PharmD, RPh, CDE Assistant Professor, Leslie Dan Faculty of Pharmacy Sun Life Financial Professor in Wellness

More information

SHORT CLINICAL GUIDELINE SCOPE

SHORT CLINICAL GUIDELINE SCOPE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SHORT CLINICAL GUIDELINE SCOPE 1 Guideline title Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes 1.1 Short title Type 2

More information

GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria

GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria GLP-1 Receptor Agonists (Byetta /Victoza ) Step Therapy Criteria Brand Generic Dosage Form Byetta exenatide subcutaneous injection Victoza liraglutide subcutaneous injection PROGRAM OBJECTIVES The intent

More information

Insulin myths and facts

Insulin myths and facts london medicines evaluation network Insulin myths and facts Statement 1 Insulin is the last resort for patients with Type 2 diabetes After initial metformin and sulfonylurea therapy, NICE and SIGN suggest

More information

Diabetes Medications in CKD. Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology

Diabetes Medications in CKD. Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology Diabetes Medications in CKD Dr Adam White, MD FRCPC Endocrinology and Metabolism UBC and SPH Division of Endocrinology Objectives Broadly review the current agents used for glycemic management in Type

More information

Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians

Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians Clinician Research Summary Diabetes Type 2 Diabetes Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians A systematic review of 166 clinical studies published between

More information

Medication Policy Manual

Medication Policy Manual Medication Policy Manual Topic: Branded SGLT2-Inhibitor-Containing Medications: - canagliflozin (Invokana, Invokamet ); - dapagliflozin (Farxiga, Xigduo XR); - empagliflozin (Jardiance, Glyxambi, Synjardy

More information

Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours

Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours Strengthening the Pharmacist Skills in Managing Diabetes Practice Based Program 27 Contact Hours Presented by New York State Council of Health system Pharmacists October 18 19, 2013 St. John s University,

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Afrezza Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Afrezza (human insulin) Prime Therapeutics will review Prior Authorization requests Prior Authorization

More information

A Personalized Approach for A1C Goals

A Personalized Approach for A1C Goals PL Detail-Document #280708 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER July 2012 A Personalized Approach

More information

Treatment of Type 2 Diabetes with Special Consideration to Reduce Hypoglycemia

Treatment of Type 2 Diabetes with Special Consideration to Reduce Hypoglycemia Treatment of Type 2 Diabetes with Special Consideration to Reduce Hypoglycemia Learning Objectives After participating in this educational activity, participants should be able to: 1. Apply strategies

More information

COST ANALYSIS OF ANTIDIABETIC DRUGS FOR DIABETES MELLITUS OUTPATIENT IN KODYA YOGYAKARTA HOSPITAL

COST ANALYSIS OF ANTIDIABETIC DRUGS FOR DIABETES MELLITUS OUTPATIENT IN KODYA YOGYAKARTA HOSPITAL Malaysian Journal of Pharmaceutical Sciences, Vol. 5, No. 1, 19 23 (2007) COST ANALYSIS OF ANTIDIABETIC DRUGS FOR DIABETES MELLITUS OUTPATIENT IN KODYA YOGYAKARTA HOSPITAL TRI MURTI ANDAYANI* AND IKE IMANINGSIH

More information

Harmony Clinical Trial Medical Media Factsheet

Harmony Clinical Trial Medical Media Factsheet Overview Harmony is the global Phase III clinical trial program for Tanzeum (albiglutide), a product developed by GSK for the treatment of type 2 diabetes. The comprehensive program comprised eight individual

More information

Medication Policy Manual. Topic: Non-Preferred Injectable Insulins. Date of Origin: November 13, Apidra - Apidra SoloStar - Novolin N -

Medication Policy Manual. Topic: Non-Preferred Injectable Insulins. Date of Origin: November 13, Apidra - Apidra SoloStar - Novolin N - Medication Policy Manual Topic: NonPreferred Injectable Insulins Apidra Apidra SoloStar Novolin N Novolin R Novolin Mix 70/30 NovoLog NovoLog FlexPen NovoLog Mix 70/30 NovoLog Mix 70/30 FlexPen Committee

More information

嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯

嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 The Clinical Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Adults with Type 2 Diabetes Mellitus 嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 Diabetes Mellitus : A group of diseases characterized

More information

Volume 01, No. 08 November 2013

Volume 01, No. 08 November 2013 State of New Jersey Department of Human Services Division of Medical Assistance & Health Services New Jersey Drug Utilization Review Board Volume 01, No. 08 November 2013 TO: SUBJECT: PURPOSE: Physicians,

More information

Review of Diabetes Therapies: Key Drivers of Disease Progression

Review of Diabetes Therapies: Key Drivers of Disease Progression Review of Diabetes Therapies: Key Drivers of Disease Progression David M. Kendall, MD Medical Director and Chief of Clinical and Professional Services Associate Professor of Medicine University of Minnesota

More information

Reconciling Current Diabetes Guidelines

Reconciling Current Diabetes Guidelines Reconciling Current Diabetes Guidelines Jaime A. Davidson, MD, FACP. FACE Part 1. Diagnosis Welcome. I am Dr. Jaime Davidson, a clinical professor of medicine in the Department of Internal Medicine, Division

More information

A NEW TAKE ON DIABETES MEDICATIONS: RISKS AND BENEFITS, OLD MEDICATIONS VERSUS NEW, AND NEW INFORMATION ON OLD MEDICATIONS

A NEW TAKE ON DIABETES MEDICATIONS: RISKS AND BENEFITS, OLD MEDICATIONS VERSUS NEW, AND NEW INFORMATION ON OLD MEDICATIONS A NEW TAKE ON DIABETES MEDICATIONS: RISKS AND BENEFITS, OLD MEDICATIONS VERSUS NEW, AND NEW INFORMATION ON OLD MEDICATIONS JESSICA CONKLIN, PHARMD, PHC, BCACP, CDE VISITING ASSISTANT PROFESSOR UNM COLLEGE

More information

Prescribing for Diabetes. England 2005-06 to 2013-14

Prescribing for Diabetes. England 2005-06 to 2013-14 Prescribing for Diabetes England 2005-06 to 2013-14 Published 12 August 2014 We are the trusted national provider of high-quality information, data and IT systems for health and social care. www.hscic.gov.uk

More information

Prediabetes: A Woman s Perspective

Prediabetes: A Woman s Perspective Prediabetes: A Woman s Perspective AMERICAN COLLEGE OF ENDOCRINOLOGY CONSENSUS STATEMENT ON THE DIAGNOSIS AND MANAGEMENT OF PRE-DIABETES IN THE CONTINUUM OF HYPERGLYCEMIA Joanne Kaiser-Smith, D.O., FACOI,

More information

Which drugs should be used to treat diabetes in cirrhotic patients?

Which drugs should be used to treat diabetes in cirrhotic patients? Which drugs should be used to treat diabetes in cirrhotic patients? Frankfurt am Main 10-12 September 2015 Jörg Bojunga Medizinische Klinik I Johann Wolfgang Goethe-Universität Frankfurt am Main Significance

More information

Canadian Diabetes Associatin Patient Group Input Submission to the Common Drug Review at CADTH

Canadian Diabetes Associatin Patient Group Input Submission to the Common Drug Review at CADTH Canadian Diabetes Associatin Patient Group Input Submission to the Common Drug Review at CADTH Section 1 General Information Name of the drug CADTH is reviewing and indication(s) of interest Synjardy (empagliflozin

More information

Drug Class Review. Newer Diabetes Medications and Combinations

Drug Class Review. Newer Diabetes Medications and Combinations Drug Class Review Newer Diabetes Medications and Combinations Final Streamlined Update 1 Report June 2014 The purpose of Drug Effectiveness Review Project reports is to make available information regarding

More information

DIABETES MEDICATIONS

DIABETES MEDICATIONS CLINICAL POLICY DIABETES MEDICATIONS Policy Number: PHARMACY 242.8 T2 Effective Date: January 1, 2016 Table of Contents CONDITIONS OF COVERAGE... COVERAGE RATIONALE... BENEFIT CONSIDERATIONS... BACKGROUND...

More information

Nutrition. Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT

Nutrition. Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT 1 Nutrition Type 2 Diabetes: A Growing Challenge in the Healthcare Setting NAME OF STUDENT 2 Type 2 Diabetes: A Growing Challenge in the Healthcare Setting Introduction and background of type 2 diabetes:

More information

Type 2 Diabetes Medicines: What You Need to Know

Type 2 Diabetes Medicines: What You Need to Know Type 2 Diabetes Medicines: What You Need to Know Managing diabetes is complex because many hormones and body processes are at work controlling blood sugar (glucose). Medicines for diabetes include oral

More information

Prescribing for Diabetes, England 2005-06 to 2012-13

Prescribing for Diabetes, England 2005-06 to 2012-13 Prescribing for Diabetes, England 2005-06 to 2012-13 Published 13 August 2013 This product is relevant to members of the public and other stakeholders to support the understanding of primary care prescribing

More information

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study National Diabetes Information Clearinghouse U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH What

More information

Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group. Learning Objectives. Background. CAPA 2015 Annual Conference

Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group. Learning Objectives. Background. CAPA 2015 Annual Conference Treating Patients with PRE-DIABETES David Doriguzzi, PA-C First Valley Medical Group Learning Objectives To accurately make the diagnosis of pre-diabetes/metabolic syndrome To understand the prevalence

More information

Update on the management of Type 2 Diabetes

Update on the management of Type 2 Diabetes Update on the management of Type 2 Diabetes Mona Nasrallah M.D Assistant Professor, Endocrinology American University of Beirut 10 th Annual Family Medicine Conference October 14,2011 Global Prevalence

More information

Insulin degludec (Tresiba) for the Management of Diabetes: Effectiveness, Value, and Value-Based Price Benchmarks

Insulin degludec (Tresiba) for the Management of Diabetes: Effectiveness, Value, and Value-Based Price Benchmarks Background: Insulin degludec (Tresiba) for the Management of Diabetes: Effectiveness, Value, and Value-Based Price Benchmarks Final Background and Scope November 19, 2015 The Centers for Disease Control

More information

Primary Care Type 2 Diabetes Update

Primary Care Type 2 Diabetes Update Primary Care Type 2 Diabetes Update May 16, 2014 Presented by: Barb Risnes APRN, BC-ADM, CDE Objectives: Discuss strategies to address common type 2 diabetes patient management challenges Review new pharmacological

More information

Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data?

Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data? Kardiovaskulär säkerhet vid behandling av typ 2-diabetes Vad säger senaste data? Michael Alvarsson Kliniken för Endokrinologi, Metabolism och Diabetes Karolinska Universitetssjukhuset Solna Near-normal

More information

David Shu, MD, FRCPC Endocrinology, Royal Columbian Hospital October 8 th, 2010

David Shu, MD, FRCPC Endocrinology, Royal Columbian Hospital October 8 th, 2010 David Shu, MD, FRCPC Endocrinology, Royal Columbian Hospital October 8 th, 2010 Objectives At the end of the talk, the participants will be able to: 1. Identify the increasing prevalence of type 2 diabetes

More information

PCORI Methodology Standards: Academic Curriculum. 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved.

PCORI Methodology Standards: Academic Curriculum. 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved. PCORI Methodology Standards: Academic Curriculum 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved. Module 9: Putting it All Together: Appraising a Systematic Review Category 11: Systematic

More information

linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd

linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd 09 December 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of

More information

Controversies in the Management of Patients with Type 2 Diabetes

Controversies in the Management of Patients with Type 2 Diabetes The New England Comparative Effectiveness Public Advisory Council Public Meeting October 29, 2014 Controversies in the Management of Patients with Type 2 Diabetes Final Report December 2014 Authored by:

More information

Diabetes Mellitus 1. Chapter 43. Diabetes Mellitus, Self-Assessment Questions

Diabetes Mellitus 1. Chapter 43. Diabetes Mellitus, Self-Assessment Questions Diabetes Mellitus 1 Chapter 43. Diabetes Mellitus, Self-Assessment Questions 1. A 46-year-old man presents for his annual physical. He states that he has been going to the bathroom more frequently than

More information

4. Does your PCT provide structured education programmes for people with type 2 diabetes?

4. Does your PCT provide structured education programmes for people with type 2 diabetes? PCT Prescribing Report Drugs used in Type 2 Diabetes Discussion Points 1. Does your PCT have a strategy for prevention of type 2 diabetes? Does your PCT provide the sort of intensive multifactorial lifestyle

More information

Outline: International Diabetes Federation 2013 11/13/2014. Top 10 countries for prevalence (%) of diabetes (20-79 years) - 2013

Outline: International Diabetes Federation 2013 11/13/2014. Top 10 countries for prevalence (%) of diabetes (20-79 years) - 2013 ZN, 14AY (11/11/2014) 2 Outline: AMERICAN DIABETES ASSOCIATION UPDATES IN STANDARDS OF MEDICAL CARE IN DIABETES - 2014 Dr. Ziad Nasr, BSc Pharm., Pharm.D. Define current criteria for the diagnosis of diabetes

More information

Type 2 Diabetes Media Fact Sheet

Type 2 Diabetes Media Fact Sheet Type 2 Diabetes Media Fact Sheet 1. Type 2 diabetes: Facts & figures 2. What is type 2 diabetes? 3. Risk factors for type 2 diabetes 4. Complications associated with type 2 diabetes 5. The socio-economic

More information

Clinical Assistant Professor. Clinical Pharmacy Specialist Wesley Family Medicine Residency Program. Objectives

Clinical Assistant Professor. Clinical Pharmacy Specialist Wesley Family Medicine Residency Program. Objectives What s New in Diabetes Medications? Matthew Kostoff, PharmD, BCPS, BCACP Clinical Assistant Professor Clinical Pharmacy Specialist Wesley Family Medicine Residency Program Objectives Discuss new literature

More information

Pharmaceutical Management of Diabetes Mellitus

Pharmaceutical Management of Diabetes Mellitus 1 Pharmaceutical Management of Diabetes Mellitus Diabetes Mellitus (cont d) Signs and symptoms 2 Elevated fasting blood glucose (higher than 126 mg/dl) or a hemoglobin A1C (A1C) level greater than or equal

More information

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center

More information

PEER REVIEW HISTORY ARTICLE DETAILS

PEER REVIEW HISTORY ARTICLE DETAILS PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Treatment of Type 2 Diabetes

Treatment of Type 2 Diabetes Improving Patient Care through Evidence Treatment of Type 2 Diabetes This information is based on a comprehensive review of the evidence for best practices in the treatment of type 2 diabetes and is sponsored

More information

Britni Hebert, MD PGY-1

Britni Hebert, MD PGY-1 Britni Hebert, MD PGY-1 Importance of Diabetes treatment Types of treatment Comparison of treatment/article Review Summary Example cases 1 out of 13 Americans have diabetes Complications include blindness,

More information

Newer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013

Newer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013 Newer Anticoagulants and Newer Diabetic Drug Classes Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013 Apixaban Newer Anticoagulants Dabigatran etexilate Rivaroxaban

More information

Trends in Prescribing of Drugs for Type 2 Diabetes in General Practice in England (Chart 1) Other intermediate and long-acting insulins

Trends in Prescribing of Drugs for Type 2 Diabetes in General Practice in England (Chart 1) Other intermediate and long-acting insulins Type 2 Diabetes Type 2 diabetes is the most common form of diabetes, accounting for 90 95% of cases. 1 Charts 1 and 2 reflect the effect of increasing prevalence on prescribing and costs of products used

More information

Adult Diabetes Clinician Guide

Adult Diabetes Clinician Guide Kaiser Permanente National CLINICAL PRACTICE GUIDELINES Adult Diabetes Clinician Guide Introduction JANUARY 2016 This evidence-based guideline summary is based on the 2016 National Diabetes Guideline.

More information

The Diabetes Epidemic: Family Physicians at the Front Line. Presenter s Guide

The Diabetes Epidemic: Family Physicians at the Front Line. Presenter s Guide The Diabetes Epidemic: Family Physicians at the Front Line Presenter s Guide Introduction As part of the Highlight on Diabetes program, we are pleased to provide you with this Slide Presentation and Presenter

More information

Does Diabetes Control Matter?

Does Diabetes Control Matter? Does Diabetes Control Matter? Laurence Kennedy, MD, FRCP Endocrinology Department Cleveland Clinic, OH Disclosures None Does Diabetes Control Matter? Generality of patients Relative Risk Complications

More information

Type 1 Diabetes ( Juvenile Diabetes)

Type 1 Diabetes ( Juvenile Diabetes) Type 1 Diabetes W ( Juvenile Diabetes) hat is Type 1 Diabetes? Type 1 diabetes, also known as juvenile-onset diabetes, is one of the three main forms of diabetes affecting millions of people worldwide.

More information

CV Safety Outcome Trials for New Diabetes Drugs

CV Safety Outcome Trials for New Diabetes Drugs CV Safety Outcome Trials for New Diabetes Drugs Occurrences since our Think Tank J. Rick Turner, PhD, DSc, FASH, FACC Copyright 2016 QuintilesIMS. All rights reserved. Disclosure Statements and Acknowledgements

More information

CME Test for AMDA Clinical Practice Guideline. Diabetes Mellitus

CME Test for AMDA Clinical Practice Guideline. Diabetes Mellitus CME Test for AMDA Clinical Practice Guideline Diabetes Mellitus Part I: 1. Which one of the following statements about type 2 diabetes is not accurate? a. Diabetics are at increased risk of experiencing

More information

TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION. Robert Dobbins, M.D. Ph.D.

TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION. Robert Dobbins, M.D. Ph.D. TYPE 2 DIABETES MELLITUS: NEW HOPE FOR PREVENTION Robert Dobbins, M.D. Ph.D. Learning Objectives Recognize current trends in the prevalence of type 2 diabetes. Learn differences between type 1 and type

More information

Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History

Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History Emmanuel O. Aiyere 1, Jay Silverberg 2, Safina Ali 3, and Jayson L. Parker 1 1 Department of Biology, University of Toronto at Mississauga,

More information

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller

More information

Acarbose INITIAL: 25 mg PO TID ($45) Miglitol INITIAL: 25 mg PO TID ($145)

Acarbose INITIAL: 25 mg PO TID ($45) Miglitol INITIAL: 25 mg PO TID ($145) PL Detail-Document #310601 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER June 2015 Drugs for Type 2

More information

Causes, incidence, and risk factors

Causes, incidence, and risk factors Causes, incidence, and risk factors Insulin is a hormone produced by the pancreas to control blood sugar. Diabetes can be caused by too little insulin, resistance to insulin, or both. To understand diabetes,

More information

Improving drug prescription in elderly diabetic patients. FRANCESC FORMIGA Hospital Universitari de Bellvitge

Improving drug prescription in elderly diabetic patients. FRANCESC FORMIGA Hospital Universitari de Bellvitge Improving drug prescription in elderly diabetic patients FRANCESC FORMIGA Hospital Universitari de Bellvitge High prevalence, but also increases the incidence. The older the patients, the higher the percentages

More information

Medicines for Type 2 Diabetes A Review of the Research for Adults

Medicines for Type 2 Diabetes A Review of the Research for Adults Medicines for Type 2 Diabetes A Review of the Research for Adults Is This Information Right for Me? Yes, if: Your doctor or health care provider has told you that you have type 2 diabetes and have high

More information

Issued and entered this 20 th day of December 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND

Issued and entered this 20 th day of December 2010 by Ken Ross Commissioner ORDER I PROCEDURAL BACKGROUND STATE OF MICHIGAN DEPARTMENT OF ENERGY, LABOR & ECONOMIC GROWTH OFFICE OF FINANCIAL AND INSURANCE REGULATION Before the Commissioner of Financial and Insurance Regulation In the matter of XXXXX Petitioner

More information

Management of Diabetes in the Elderly. Sylvia Shamanna Internal Medicine (R1)

Management of Diabetes in the Elderly. Sylvia Shamanna Internal Medicine (R1) Management of Diabetes in the Elderly Sylvia Shamanna Internal Medicine (R1) Case 74 year old female with frontal temporal lobe dementia admitted for prolonged delirium and frequent falls (usually in the

More information

Type 2 Diabetes. Aims and Objectives. What did you consider? Case Study One: Miss S. Which to choose?!?! Modes of Action

Type 2 Diabetes. Aims and Objectives. What did you consider? Case Study One: Miss S. Which to choose?!?! Modes of Action Aims and Objectives This session will outline the increasing complexities of diabetes care, and the factors that differentiate the combinations of therapy, allowing individualisation of diabetes treatment.

More information

Submission to the PBAC Post Market Review of Products Used in the Management of Diabetes: Drug Utilisation and Listing Review

Submission to the PBAC Post Market Review of Products Used in the Management of Diabetes: Drug Utilisation and Listing Review Submission to the PBAC Post Market Review of Products Used in the Management of Diabetes: Drug Utilisation and Listing Review Boehringer Ingelheim welcomes the opportunity to comment on the Post-Market

More information

Diabetes Complications

Diabetes Complications Managing Diabetes: It s s Not Easy But It s s Worth It Presenter Disclosures W. Lee Ball, Jr., OD, FAAO (1) The following personal financial relationships with commercial interests relevant to this presentation

More information

Future Research Prioritization: Comparative Effectiveness of Second- and Third-Line Therapies for Treatment of Type 2 Diabetes

Future Research Prioritization: Comparative Effectiveness of Second- and Third-Line Therapies for Treatment of Type 2 Diabetes Future Research Prioritization: Comparative Effectiveness of Second- and Third-Line Therapies for Treatment of Type 2 Diabetes Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW,

More information

Comparative Review of Oral Hypoglycemic Agents in Adults

Comparative Review of Oral Hypoglycemic Agents in Adults SECTION 18.5 Comparative Review of Oral Hypoglycemic Agents in Adults Harinder Chahal For WHO Secretariat Table of Contents Acronyms:... 3 I. Background and Rationale for the review:... 4 II. Medications

More information

TYPE 2 DIABETES IN CHILDREN DIAGNOSIS AND THERAPY. Ines Guttmann- Bauman MD Clinical Associate Professor, Division of Pediatric Endocrinology, OHSU

TYPE 2 DIABETES IN CHILDREN DIAGNOSIS AND THERAPY. Ines Guttmann- Bauman MD Clinical Associate Professor, Division of Pediatric Endocrinology, OHSU TYPE 2 DIABETES IN CHILDREN DIAGNOSIS AND THERAPY Ines Guttmann- Bauman MD Clinical Associate Professor, Division of Pediatric Endocrinology, OHSU Objectives: 1. To discuss epidemiology and presentation

More information

Hypoglycemics, Metformins Therapeutic Class Review (TCR)

Hypoglycemics, Metformins Therapeutic Class Review (TCR) Hypoglycemics, Metformins Therapeutic Class Review (TCR) December 19, 2013 The literature review is current through February 22, 2016. No part of this publication may be reproduced or transmitted in any

More information

Imeglimin: A Potential New Multi-Target Drug for Type 2 Diabetes

Imeglimin: A Potential New Multi-Target Drug for Type 2 Diabetes Drugs R D (2015) 15:227 232 DOI 10.1007/s40268-015-0099-3 REVIEW ARTICLE Imeglimin: A Potential New Multi-Target Drug for Type 2 Diabetes Valerie Vuylsteke 1 Lisa M. Chastain 2 Geeta A. Maggu 3 Crystal

More information

New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus

New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus New Medicine Recommendations Albiglutide (Eperzan ) and Dulaglutide (Trulicity ) For Type II Diabetes Mellitus Albiglutide: Black Albiglutide is NOT recommended for use by the NHS in Lancashire. Data from

More information

Type 2 diabetes in adults: controlling your blood glucose by taking a second medicine what are your options?

Type 2 diabetes in adults: controlling your blood glucose by taking a second medicine what are your options? Patient decision aid Type 2 diabetes in adults: controlling your blood glucose by taking a second medicine what are your options? nice.org.uk/guidance/ng28 Published: December 2015 About this decision

More information

MICHIGAN TYPE 2 DIABETES REPORT 2014

MICHIGAN TYPE 2 DIABETES REPORT 2014 MICHIGAN TYPE 2 DIABETES REPORT 2014 CONTENTS Patient Demographics...3 Cases/ALOS/Hospital Charges...4 Professional Charges...5 Use of Services...6 Pharmacotherapy...6 7 Persistency...8 ADA/EASD Position

More information

New Treatments for Type 2 Diabetes

New Treatments for Type 2 Diabetes New Treatments for Type 2 Diabetes Dr David Hopkins Clinical Director, Division of Ambulatory Care King s College Hospital NHS Foundation Trust Treatments for type 2 diabetes - old & new insulin sulphonylureas

More information

Cochrane Quality and Productivity topics

Cochrane Quality and Productivity topics Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus NICE has developed the Cochrane Quality and Productivity (QP) topics to help the NHS identify practices

More information

Management of Diabetes: A Primary Care Perspective. Presentation Outline

Management of Diabetes: A Primary Care Perspective. Presentation Outline Management of Diabetes: A Primary Care Perspective Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest Presentation Outline

More information

TREATMENT PATTERN AND GLYCEMIC CONTROL OF ORAL HYPOGLYCAEMIC DRUGS AMONG TYPE II DM PATIENTS IN ERITREA

TREATMENT PATTERN AND GLYCEMIC CONTROL OF ORAL HYPOGLYCAEMIC DRUGS AMONG TYPE II DM PATIENTS IN ERITREA December 30, 2014 Archives 2014 vol.3 106-111 TREATMENT PATTERN AND GLYCEMIC CONTROL OF ORAL HYPOGLYCAEMIC DRUGS AMONG TYPE II DM PATIENTS IN ERITREA J. Shobana Preeth *1, Solomon Tsegai 1, Maekele Tsgehannes

More information

CLINICAL AUDIT TOOL: Type 2 Diabetes and Glycaemic Control

CLINICAL AUDIT TOOL: Type 2 Diabetes and Glycaemic Control CLINICAL AUDIT TOOL: Type 2 Diabetes and Glycaemic Control Introduction This clinical audit tool addresses glycaemic control for people with type 2 diabetes. It draws on best practice guidance reproduced

More information

Patterns of Medication Initiation in Newly Diagnosed Diabetes Mellitus: Quality and Cost Implications

Patterns of Medication Initiation in Newly Diagnosed Diabetes Mellitus: Quality and Cost Implications CLINICAL RESEARCH STUDY Patterns of Medication Initiation in Newly Diagnosed Diabetes Mellitus: Quality and Cost Implications Nihar R. Desai, MD, MPH, a,b William H. Shrank, MD, MSHS, a,c Michael A. Fischer,

More information

Baskets of Care Diabetes Subcommittee

Baskets of Care Diabetes Subcommittee Baskets of Care Diabetes Subcommittee Disclaimer: This background information is not intended to be a comprehensive scientific discussion of the topic, but rather an attempt to provide a baseline level

More information

PEI Diabetes Strategy

PEI Diabetes Strategy PEI Diabetes Strategy 2014-2017 Table of Contents Message from the Minister... 1 PEI Diabetes Strategy 2014-2017... 3 Setting the Stage... 3 What is Diabetes?... 3 Diabetes on Prince Edward Island...

More information

Shaping our future: a call to action to tackle the diabetes epidemic and reduce its economic impact

Shaping our future: a call to action to tackle the diabetes epidemic and reduce its economic impact Shaping our future: a call to action to tackle the diabetes epidemic and reduce its economic impact Task Force for the National Conference on Diabetes: The Task Force is comprised of Taking Control of

More information

Type 2 diabetes Definition

Type 2 diabetes Definition Type 2 diabetes Definition Type 2 diabetes is a lifelong (chronic) disease in which there are high levels of sugar (glucose) in the blood. Type 2 diabetes is the most common form of diabetes. Causes Diabetes

More information

Type 2 Diabetes Report 2015

Type 2 Diabetes Report 2015 SINCE 1987 MANAGED CARE DIGEST SERIES Type 2 Diabetes Report 2015 With a Focus on Demographic, Utilization, Charge and Pharmacotherapy Data in partnership with the 3rd Edition FLORIDA TYPE 2 DIABETES REPORT

More information

Product Theaters. Light refreshments provided by the American Diabetes Association will be served to the first 300 attendees.

Product Theaters. Light refreshments provided by the American Diabetes Association will be served to the first 300 attendees. Product Theaters Product Theaters, located in the rear of the Exhibit Hall, offer informative sessions focusing on particular products or a single facet of diabetes. Product Theater sessions do not provide

More information

Diabetes Mellitus. Melissa Meredith M.D. Diabetes Mellitus

Diabetes Mellitus. Melissa Meredith M.D. Diabetes Mellitus Melissa Meredith M.D. Diabetes mellitus is a group of metabolic diseases characterized by high blood glucose resulting from defects in insulin secretion, insulin action, or both Diabetes is a chronic,

More information

Diabetes 101: A Brief Overview of Diabetes and the American Diabetes Association What Happens When We Eat?

Diabetes 101: A Brief Overview of Diabetes and the American Diabetes Association What Happens When We Eat? Diabetes 101: A Brief Overview of Diabetes and the American Diabetes Association What Happens When We Eat? After eating, most food is turned into glucose, the body s main source of energy. 1 Normal Blood

More information

Targeting the Kidney. Renal Glucose Transport 11/4/2015. Non insulin Agents Available IBITORS. Chao EC, et al. Nat Rev Drug Discovery. 2010;9:551 559.

Targeting the Kidney. Renal Glucose Transport 11/4/2015. Non insulin Agents Available IBITORS. Chao EC, et al. Nat Rev Drug Discovery. 2010;9:551 559. SGLT-2i and DPP-IVi in the Management of Diabetes Mellitus Type 2 Abel Alfonso, D.O., F.A.C.E. Endocrinologist November 5, 2015 DIABETES: CURRENT RATES AND PROJECTIONS CDC Press Release 2010: 1 in 3 adults

More information

New and Future Treatments for Diabetes. Mary Charlton Specialty Doctor in Diabetes University Hospital Birmingham BARS Oct 2014

New and Future Treatments for Diabetes. Mary Charlton Specialty Doctor in Diabetes University Hospital Birmingham BARS Oct 2014 New and Future Treatments for Diabetes Mary Charlton Specialty Doctor in Diabetes University Hospital Birmingham BARS Oct 2014 Conflicts of interest Investigator Carmelina study of Linagliptin (Boehringer

More information

TREATMENT STRATEGIES FOR MANAGING TYPE 2 DIABETES MELLITUS. Friday, August 16, 13

TREATMENT STRATEGIES FOR MANAGING TYPE 2 DIABETES MELLITUS. Friday, August 16, 13 TREATMENT STRATEGIES FOR MANAGING TYPE 2 DIABETES MELLITUS 1 Heather Healy, FNP-BC Martha Shelver, CS, ACNP-BC Saint Alphonsus Regional Medical Center 2 OBJECTIVES 3 Review the current management algorithms

More information

Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Diabetes sections of the Guidelines)

Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Diabetes sections of the Guidelines) Cardiovascular Health Nova Scotia Guideline Update Nova Scotia Guidelines for Acute Coronary Syndromes (Updating the 2008 Diabetes sections of the Guidelines) Authors: Dr. M. Love, Kathy Harrigan Reviewers:

More information

Overview of Diabetes Medications

Overview of Diabetes Medications Overview of Diabetes Medications Marie Frazzitta DNP, FNP c, CDE, MBA Senior Director of Disease Management North Shore LIJ Health Systems Normal Glucose Metabolism Insulin is produced by beta cells in

More information

ESC/EASD Pocket Guidelines Diabetes, pre-diabetes and cardiovascular disease

ESC/EASD Pocket Guidelines Diabetes, pre-diabetes and cardiovascular disease Diabetes, prediabetes and cardiovascular disease Classes of recommendations Levels of evidence Recommended treatment targets for patients with diabetes and CAD Definition, classification and screening

More information

It s time to TALK Targets A guide to taking control of your type 2 diabetes

It s time to TALK Targets A guide to taking control of your type 2 diabetes It s time to TALK Targets A guide to taking control of your type 2 diabetes The TALK Targets campaign was initiated and fully funded by Novo Nordisk. By supporting you and your healthcare team, TALK Targets

More information