Powerful Use of Insulin in Diabetes: Update for 2007

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Powerful Use of Insulin in Diabetes: Update for 2007 Kenneth S. Hershon, MD Director of Research North Shore Diabetes and Endocrine Associates New Hyde Park, New York Assistant Clinical Professor of Medicine Albert Einstein College of Medicine Bronx, New York

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? Key Question Completely agreeable Somewhat agreeable Slightly agreeable Not happy at all Use your keypad to vote now! How agreeable would you say you are with starting insulin treatment in your patient populace?

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Faculty Disclosure Dr Hershon: honorarium, examine bolster, speakers department: Eli Lilly and Company, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Pharmaceuticals Inc, Pfizer Inc, sanofi-aventis Group.

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Learning Objectives State current administration objectives for diabetes Identify boundaries to ideal utilization of insulin, and how to defeat them Discuss the parts of short-, middle , and long-acting insulins in the administration of diabetes

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A1C Targets Suggested by Different Organizations Optimal target: A1C < 6% (typical range) *As near ordinary ( <6%) without huge hypoglycemia. AACE = American Association of Clinical Endocrinologists; ADA = American Diabetes Association; EASD = European Association for the Study of Diabetes.

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State of Diabetes in America: Blood Sugar Control Across the United States as Measured by A1C National normal = 67% above objective (A1C  6.5%) WA 68.4 ME 27.2 MT 55.2 ND 29.7 MN 59.3 VT = 26.7 NH = 20.4 MA = 29.5 CT = 28.4 RI = 29.5 NJ = 67.3 DE = 66.4 MD = 68.1 VT OR 64.2 NH ID 63.3 NY 71.1 W 24.2I SD 24.6 MA MI 65.4 WY 63.0 CT RI IA 58.9 PA 70.9 NE 56.5 NJ OH 71.7 NV 67.3 IL 72.6 IN 66.4 MD UT 72.4 DE CO 67.1 WV 69.5 CA 34.5 VA 67.7 KS 67.0 KY 66.8 MO 66.2 NC 65.7 TN 65.6 OK 65.6 AR 69.6 AZ 67.3 SC 66.3 NM 68.6 MS 72.8 AL 71.3 GA 69.3 LA 71.3 TX 67.7 FL 63.9 N > 157,000 Top 10 Highest AACE. Condition of Diabetes in America. May 2005. Accessible at: http://www.aace.com/open/mindfulness/stateofdiabetes/DiabetesAmericaReport.pdf

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Diabetes Demographics in the United States Population Aged ≥ 20 Years Physician-Diagnosed Diabetes (%) Undiagnosed Diabetes (%) Adapted from: National Center for Health Statistics. Wellbeing, United States, 2006. With Chartbook on Trends in the Health of Americans. Hyattsville, MD: 2006.

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No A1C Threshold in Type 2 Diabetes Epidemiologic Data From the UKPDS 80 Myocardial localized necrosis Microvascular end focuses 60 AACE Goal Adjusted Incidence per 1000 Person-Years (%) 40 20 ? 0 5 6 7 8 9 10 11 Updated Mean A1C (%) UKPDS = United Kingdom Prospective Diabetes Study. Stratton IM et al. BMJ . 2000;321:405-412.

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Risk Factor Control in Adults With Diabetes: NHANES III (1988-1994)/NHANES 1999-2000 NHANES III, n = 1204 NHANES 1999-2000, n = 370 48.2% 50 44.3% P < .001 37.0% 40 35.8% 33.9% 29.0% 30 Patients (%) 20 10 7.3% 5.2% 0 A1C < 7% BP < 130/80 mm Hg TC < 200 mg/dL Good control* *Achieved every one of the 3 showed objectives. BP = circulatory strain; NHANES = National Health and Nutrition Examination Survey; TC = add up to cholesterol. Saydah SH et al. JAMA . 2004;291:335-342.

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Stages of Type 2 Diabetes: Criteria for Advancing to Next Stage? A1C not at target:  7.0% 100 Monotherapy 75 Combination oral treatment β - Cell Function (% β ) 50 Insulin 25 Type 2 Diabetes Phase I Type 2 Diabetes Phase II Phase III 0 - 12 - 10 - 6 - 2 0 2 6 10 14 Years From Diagnosis Based on information of UKPDS 16. UKPDS Group. Diabetes. 1995;44:1249-1258.

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Biggest Clinical Hurdle? + Insulin + Oral combo + insulin + Oral mix + Oral monotherapy Diet and practice Stepwise Management of Type 2 Diabetes Adapted from Williams G. Lancet. 1994;343:95-100.

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? Key Question What is the rough sum that A1C can be brought down through utilization of oral specialists? 1% 2% 3% 4% Use your keypad to vote now!

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Antihyperglycemic Monotherapy Maximum Therapeutic Effect on A1C Acarbose Nateglinide Sitagliptin Rosiglitazone Pioglitazone Repaglinide Glimepiride Glipizide GITS Metformin Insulin 0 - 1.0 - 1.5 - 2.0 - 0.5 Reduction in A1C (%) Precose [PI]. West Haven, Conn: Bayer; 2003; Aronoff S et al. Diabetes Care. 2000;23:1605-1611; Garber AJ et al. Am J Med . 1997;102:491-497; Goldberg RB et al. Diabetes Care . 1996;19:849-856; Hanefeld M et al. Diabetes Care. 2000;23:202-207; Lebovitz HE et al. J Clin Endocrinol Metab. 2001;86:280-288; Simonson DC et al. Diabetes Care. 1997;20:597-606; Wolfenbuttel BH, van Haeften TW. Drugs . 1995;50:263-288.

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9 8 7 A1C (%) ULN = 6.2% 6 5 0 1 2 3 4 5 6 Years From Randomization UKPDS: Early Initiation of Insulin Therapy Improves A1C Control Conventional treatment Insulin treatment Sulfonylurea ± insulin treatment ULN = furthest point of confinement of A1C nondiabetic go. Wright An et al. Diabetes Care . 2002;25:330-336.

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Clinical Inertia: "Inability to Advance Therapy When Required" Last A1C Value Before Abandoning Treatment 10 9.6% 9.1% Mean A1C finally Visit (%) 9 8.6% 8.8% 8 ADA Goal 7 Sulfonylurea Combination Diet/Exercise Metformin 2.5 Years 2.9 Years 2.2 Years 2.8 Years Brown JB et al. Diabetes Care. 2004;27:1535-1540.

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? Key Question What are the obstructions for your patients with sort 2 diabetes in regards to start of insulin treatment? Worry that insulin utilize is "always" Fear of infusion Equating insulin use with compounding diabetes and inconveniences Fear of weight pick up Use your keypad to vote now!

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Patient Barriers to Insulin Use: Perception versus Reality OAD = oral antidiabetic tranquilize. Meese J. Diabetes Educ . 2006;32:9S-18S; Peyrot M et al. Diabet Med. 2005;22:1379-1385.

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Clinician Barriers to Insulin Use: Perception versus Reality Douek IF et al. Diabet Med . 2005;22:634-640; Malmberg K et al. J Am Coll Cardiol . 1995;26:57-65; Malmberg K et al. BMJ. 1997;314:1512-1515; Romano G et al. Diabetes. 1997;46:1601-1606; UKPDS Group. Lancet. 1998;352:837-853.

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Information and Patient Education Links for Healthcare Professionals American Association of Diabetes Educators (www.diabeteseducator.org) American Association of Clinical Endocrinologists (www.aace.com) American Diabetes Association (www.diabetes.org) International Diabetes Federation (www.idf.org) National Diabetes Education Initiative (www.ndei.org) National Diabetes Education Program (ndep.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (www2.niddk.nih.gov)

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Next Steps… What do we accomplish for the patient who has fizzled on 1 or 2 oral specialists?

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Basal Insulin Therapy Usual initial step when starting insulin treatment Continue OAD and add basal insulin to upgrade FPG A1C of up to 9.0% frequently conveyed to objective by option of basal insulin treatment to OADs Easy and safe: persistent coordinated treatment calculations with little danger of genuine hypoglycemia ADA and EASD prescribed: "In spite of the fact that 3 OADs can be utilized, start and heightening of insulin treatment is favored in light of viability and cost" FPG = fasting plasma glucose. ADA. Diabetes Care . 2006:29(suppl 1):S4-S42; AACE position articulation. Accessible at: http://www.aace.com/bar/pdf/rules/OutpatientImplementationPositionStatement.pdf. Nathan DM et al. Diabetes Care . 2006;29:1963-1972.

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Rationale for Basal Insulin Therapy: Insulin and Glucose Patterns Basal insulin Normal T2DM Glucose Insulin 400 120 100 300 80 μ U/mL mg/dL 200 60 40 100 20 6:00 10:00 14:00 18:00 22:00 2:00 6:00 10:00 14:00 18:00 22:00 2:00 6:00 B L D B L D Time B = breakfast; D = supper; L = lunch; T2DM = sort 2 diabetes mellitus. Polonsky KS et al. N Engl J Med. 1988;318:1231-1239.

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Options for Initiating Insulin Therapy Basal insulin NPH insulin (at sleep time) Insulin detemir (here and there every day) Insulin glargine (once day by day) Premixed insulin arrangements 70/30 NPH insulin/consistent insulin 50/50 NPL insulin/insulin lispro 70/30 NPA insulin/insulin aspart 75/25 NPL insulin/insulin lispro "Premixed insulins are not suggested amid conformity on measurements" 1 Analog premixes NPA = nonpartisan protamine aspart; NPL = impartial protamine lispro. 1. Nathan DM et al. Diabetes Care . 2006;29:1963-1972.

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Idealized Profiles of Human Insulin and Basal Insulin Analogs NPH Plasma Insulin Levels Detemir Glargine 2:00 4:00 6:00 8:00 12:00 14:00 16:00 18:00 20:00 22:00 24:00 0:00 10:00 Time Plank J et al. Diabetes Care . 2005;28:1107-1112; Rave K et al. Diabetes Care. 2005;28:1077-1082; Rosenstock J, Goldstein BJ, et al, eds. Course reading of Type 2 Diabetes . London, UK, and New York, NY: Martin Dunitz; 2003:131-154.

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Breakfast Lunch Dinner Insulin Action 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 Time Twice-Daily Split-Mixed Regimens or Lispro Mix (75/25) – Aspart Mix (70/30) Glucose levels Insulin levels Adapted with authorization from Leahy J. In: Leahy J, Cefalu W, eds. Insulin Therapy . New York: Marcel Dekker; 2002:87; Nathan DM. N Engl J Med. 2002;347:1342-1349.

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Open-Label, Twice-Daily Exenatide versus Once-Daily Insulin Glargine: Self-Monitoring Blood Glucose Profiles (n = 549) Insulin glargine 10 U/d, titrated to target FPG <100 mg/dL Exenatide 5 μ g offer first 4 weeks, then 10 μ g offer 240 220 200 Blood glucose (mg/dL) 180 160 140 Baseline (week 0) 120 Baseline (week 0) Endpoint (week 26) Endpoint (week 26) 100 Prelunch Predinner 3 AM 3 AM Prebreakfast Both pharmaceuticals brought A1C from 8.2% down to 7.1% from benchmark Weight change: exenatide –2.3 kg, glargine +1.8 kg Nausea: exenatide 57.1%, glargine 8.6% Heine RJ et al. Ann Intern Med. 2005;143:559-569.

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STEP 4 STEP 2 STEP 1 STEP 3 Add insulin Last dinner Glargine, Detemir, or NPH HS Weekly

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