Biotechnology: Its Promises and Pathways. Spring 2006 Series

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2 Biotechnology: Its Promises and Pathways Spring 2006 Series

3 The Innovators Diabetes: How Sweet It Isn t! R. Keith Campbell, RPh, CDE Fosberg Distinguished Professor of Pharmacy Department of Pharmacotherapy College of Pharmacy

4 Diabetes Facts: Scary but True Over 6.8% of U.S. Population has diabetes 20.8 million people with diabetes in the U.S. 1 of every 3 babies born today will develop diabetes in his/her lifetime 1 in every 5 dollars spent on health care is for diabetes: $134 billion/year

5 Diabetes Facts: Scary but True Fastest growing segments of the population are people years old and adolescents developing type 2 diabetes Diabetes in Washington State affects 1.3 million patients/family; kills 4000/year; is a factor in 67,000 hospitalizations & accounts for > $1 Billion just in hospitalizations Number of diabetes patients will double in the world within 10 years

6 Status of Diabetes Management Majority of patients with type 2 diabetes have only fair to poor metabolic control Fasting serum glucose levels of 200 mg/dl HbA 1c levels of > 9% Postprandial blood glucose levels average ~300 mg/dl < 2% of American adults with diabetes receive optimal quality of care Beckles GLA et al. Diabetes Care. 1998;21: American Diabetes Association. Diabetes Care. 1998;21(Suppl 1). Colwell JA. Ann Intern Med. 1996;124(1pt2): Abraira C et al. Diabetes Care. 1992;15: Klein R et al. Am J Epidemiol. 1987;126: Cowie CC et al. Diabetes in America. 2 nd ed.

7 Diabetes Healthcare System Problems Managed Care Places Barriers to Optimal Care Greater than 90% of patients are seen only by primary care physicians 70% of patients receive no diabetes education 70% of patients do not receive annual eye exams Less than half of all patients perform SMBG appropriately Harris MI et al. Ann Intern Med 1996 Jan 1;124(1 Pt 2):117-22

8 ADA Standards of Care Physician Visits 2-4 per year HbA1c Measurement 2-4 per year Fasting Glucose Measurement / (SMBG) 4-6 per year/daily Foot Exams Every Visit Aspirin Daily Urine Protein Measurements Yearly Blood Pressure As needed to achieve goals Lipid Levels Dilated Pupil Eye Exam Flu and Pneumovax As needed to achieve goals Yearly As needed

9 % of Population Prevalence of Glucose Intolerance in the United States Diabetes Undiagnosed diabetes Impaired glucose tolerance Age Kenny SJ et al. In: Diabetes in America. 2 nd ed. 1995;chap 4.

10 Patients with diabetes are impacted by many groups and health care providers including: Physicians Universities research and education programs Local hospital patient support groups Other diabetes patients Pharmaceutical manufacturers State diabetes control projects The NIH Center For Disease Control Government & private health care programs Managed care organizations Nurses RD s Pharmacists Eye docs Podiatrists Physician Assistants Dermatologists AADE The Amer. Diabetes Assoc.

11 Insulin Resistance A core defect in type 2 diabetes - 92% of patients with type 2 diabetes have insulin resistance Definition: Impaired response to the physiological effects of insulin Deterioration of the beta cell over time Haffner SM et al. Diabetes Care 1999;22: Consensus Development Conference of the American Diabetes Association. Diabetes Care 1998;21:

12 The Metabolic Syndrome of Insulin Resistance Complex Dyslipidemia Inc TG, sdldl Dec HDL Disordered Fibrinolysis Endothelial Dysfunction Insulin Resistance Systemic Inflammation Atherosclerosis Hypertension Type 2 Diabetes Visceral Obesity Adapted from the Consensus Development Conference of the American Diabetes Association. Diabetes Care 1998;21: Pradhan AD et al. JAMA 2001;286:

13 Timeline for Utilization of Therapies Glucose Relative Function Lifestyle At risk for Diabetes Metformin, TZD, AGI, Incretins SU Insulin Meglitinide Post Meal Glucose Beta cell failure Years of Diabetes Fasting Glucose Insulin Resistance Insulin Level International Diabetes Center. From Kendall D, Bergenstal R.

14 Priorities of Care for Adults with Diabetes Diagnosis and Prevention Prediabetes (IFG -IGT) - Metabolic Syndrome Diabetes Self-Management Skills Lifestyle Patient education BG monitoring Medical nutrition Physical activity Behavioral Health Emotional assessment distress, depression, complications Support needs family, peers, medical Glucose Insulin resistance Lipids Hypertension Microvascular Complications Other Essentials of Care CVD Risk ASA, Tobacco, ACEI/ARB, Statin Hemoglobin A1C Target < 7.0% SMBG Pre mg/dl Post <160 mg/dl (~ 50% of readings) Combination Rx Insulin therapy Insulin sensitizers Annual Lipid Profile LDL < 100 HDL > 40 Trigs < 150 Statin Fibrate Niacin TZD Ezetimibe Combination Rx Blood Pressure (every visit) Dx and Rx = 130/80 ACEI or Thiazide based-rx Combo therapy 2005 International Diabetes Center. All rights reserved. Annual Screening Nephropathy Microalbumin screening Retinopathy Dilated retinal exam Neuropathy Neuro and foot exam Sexual heath Hospital care Gestational DM Foot care Dental care Immunizations

15 Diabetes = Cardiovascular Disease Up to 70 % of diabetes patients die from heart disease or stroke Diabetes is a cardiovascular risk factor Diabetes treatment must include treatment of blood pressure, blood fats, blood sugar and coagulation factors

16 Treating the Metabolic Syndrome Stop smoking Eat less Exercise more Take magnesium Take aspirin Take an ace inhibitor or an arb Take a statin Take pioglitazone, metformin to reduce insulin resistance

17 Treatment Options: Needs Nutrition Education Exercise Drug therapy Self-monitoring

18 Matching Pharmacology to Pathophysiology Glucose Influx Hepatic Glucose Output Biguanides (TZD) Insulin AGI Incretins Hyperglycemia TZD (Biguanides) Insulin Sulfonylureas Meglitinides Insulin Insulin Secretion Peripheral Glucose Uptake

19 Prototype Pulmonary Insulin Delivery System: Exubera

20 PDC Technosphere /Insulin Fastest onset of any insulin-mimics first phase insulin release Highest bioavailability (40-50%) Initial studies suggest less variable absorption

21 Generex: Buccal Insulin Delivery Oral-Lyn: Absorbed directly via the oral mucosa Aminopeptidase inhibitors may need to be added

22 FDA Approved CGM Devices Device GlucoWatch CGMs Gold Guardian 1 Invasive? No? Yes Yes Real-time/ Retrospective? Real-time Retrospective Real-time Frequency of Data? Every 10 minutes up to 13 hours Every 5 minutes up to 72 hours Alarm only Alarm? Low, high Pending low No Low, high

23 Investigational Devices Device Invasive? Real-time/ Retrospective? Frequency of Data? Alarm? Navigator DesCom Guardian RealTime Yes Yes Yes Real-time Real-time Real-time Every minute Every 5 minutes Every 5 minutes Low, high Low, high Pending low/high Pending low/high Low, high

24 FreeStyle Navigator Continuous Glucose Monitor Transmitter Sensor/Sensor Mount Receiver Investigational Device

25 Experimental but Promising New Medications to Treat Diabetes Ruboxistaurin (Arxxant) prevents eye and kidney disease Rimonabant (Acomplia) inhibits the effects of cannabis and results in weight loss, smoking cessation and improved insulin resistance Adiponectin type products

26 VEGF and PKC-ß Inhibition VEGF VEGF+PKCßi

27 Diabetes and WSU The Diabetes Initiative Educational programs from Pharmacy, Nursing, Extension, FSHN and others Clinical research from Pharmacy, Nursing, FSHN, Health Care Policy Administration and other departments Basic science research from Biochemistry, Veterinary Medicine, Pharmacy

28 Conclusions Questions and comments Thank you so much for your time and attention; it is much appreciated.

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30 Coming Up The Innovators lecture series in Seattle

31 The Innovators Epigenetics, Heredity, and the Environment: The Ghost in Your Genes Michael K. Skinner, Ph.D. Director and Professor, Center for Reproductive Biology Center for Integrated Biotechnology School of Molecular Biosciences

32 The Innovators Why Diseases Emerge: The World of Surveillance, Risk, and Response Guy H. Palmer, DVM, Ph.D. Diplomate, American College of Veterinary Pathologists Professor of Microbiology and Pathology College of Veterinary Medicine

33 For more information: Toll free