Learning Objectives. Impact of Diabetes II UPDATES IN TYPE 2 DIABETES. David Doriguzzi, PA-C

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1 UPDATES IN TYPE 2 DIABETES David Doriguzzi, PA-C Learning Objectives Upon completion of this educational activity, the participant should be able to: Overcome barriers and attitudes that limit Clinician/Patient ability to adopt standards of care for individualized patient management of type II diabetes Overcome resistance to early initiation and intensification of insulin therapy through better understanding of the benefits and risks of insulin management of type II diabetes Individualize therapy and management of patients with type II diabetes using insulin and standard, new, and emerging agents as part of combination therapy Ensure safe use of insulin therapy in hospitalized patients and better focus on the prevention of hypoglycemia Impact of Diabetes II Type 2 Diabetes Mellitus (T2DM) affects 29.1 Million Americans and 368 Million people worldwide 1 Incidence of T2DM is growing rapidly (30 Million worldwide cases of T2DM in 1985) 2 T2DM carries an annual cost of $245 Billion in the US alone 1 1. ADA Statistics about Diabetes Global Burden of Diabetes Study Lancet. 286(9995):

2 Where should we be? Are we meeting treatment recommendation standards for our diabetic patients? The American Diabetes Association (ADA) and American Academy of Clinical Endocrinologists (AACE) both provide recommendations diabetes treatment goals ADA Treatment Goals A reasonable A1c goal for most patients with T2DM is <7.0% 1 A1c < 6.5% is a good goal for healthier patients who can achieve goals without risk of hypoglycemia A1c < 8.0% is appropriate for patients with severe hypoglycemia, advanced complications, or shorter life expectancy 1. Diabetes Care. Volume 39, Supplement 1, January 2016 ADA Treatment Guide 1. Diabetes Care. Volume 39, Supplement 1, January 2016

3 AACE Treatment Goals A1c < 6.5% in patients without concurrent serious illness and at low hypoglycemic risk A1c > 6.5% in patients with concurrent serious illness and at risk for hypoglycemia 1. Diabetes Care. Volume 39, Supplement 1, January 2016 AACE Treatment Guide Clinical Inertia in Diabetes Care Patients are commonly allowed to remain in poor glycemic control for several years before therapy is intensified. Clinicians wait an average of 6 years before initiating insulin therapy in patients with A1c > 8.0%. 1. Khunti, et al. Diabetes Care. 36: , 2013 Years to intensification of therapy Additional OAD Insulin >7.0% >7.5% >8.0%

4 Why Do We Wait? Numerous barriers stand in the way of advancing therapy Patient resistance to therapy Clinician resistance Fear of hypoglycemia Low clinician comfort level with more intensive/newer treatments Lack of familiarity with newer treatment mechanisms of action Limited time and training resources Cost limitations Fear of injections Overcoming the Barriers Improve Patient Knowledge Educate patients on medication purpose and mechanism of action Meaningful conversation about treatment benefits vs risks Early discussion on the role of insulin therapy Equip patients with adequate training on the use of their medications Overcoming the Barriers Team Approach to Therapy Make sure patient goals and provider goals coincide Cooperative decision-making in therapy adjustments Consider costs to patient in decision making Follow up regularly to evaluate progress

5 Overcoming the Barriers Improve Provider Knowledge Have realistic and accurate perceptions of treatment modalities Be familiar with potential adverse effects (also helps to prepare and educate patients) Understand the pathogenesis of Diabetes 2 Understand how each medication functions in addressing hyperglycemia Pathogenesis of Diabetes 2 Ominous Octet T2DM Treatment Functions Metformin Decreases hepatic glucose output Increases muscular glucose uptake

6 T2DM Treatment Functions Sulfonylureas Increase insulin secretion Most common glipizide, glyburide, glimepiride Meglitinides (Prandin & Starlix also increase insulin secretion, but with a shorter duration of action) T2DM Treatment Functions TZDs Increase insulin sensitivity Pioglitazone (Actos) & Rosiglitazone (Avandia) T2DM Treatment Functions DPP-IV Inhibitors Reduce the breakdown of GLP- 1 in order increase the incretin effect (using native GLP-1) Januvia, Onglyza, Tradjenta, Nesina

7 T2DM Treatment Functions GLP-1 Receptor Agonists Directly activate GLP-1 receptors to increase the incretin effect (More effective incretin activation than DPP-IV inhibitors) Byetta, Bydureon, Victoza, Trulicity, Tanzeum, Lyxumia T2DM Treatment Functions SGLT-2 Inhibitors Decrease kidney reabsorption of glucose Invokana, Farxiga, Jardiance T2DM Treatment Functions Insulin Direct stimulation of insulin receptors in cell membranes to activate cellular uptake of glucose

8 Combining Therapies Most diabetics eventually require multiple medications to reach goal Combining therapies with different actions can allow specific targeting of ominous octet defects What about Insulin? Initiation of insulin has historically been an intimidating undertaking Older insulins (porcine, bovine, regular, NPH) brought frequent hypoglycemia, weight gain, and necessitated multiple daily injections These factors have contributed to several negative conceptions of insulin therapy for both patients and providers Patient Concerns Fear of pain related to injections Fear of weight gain Fear of hypoglycemia Belief that insulin is bad for you and leads to complications Belief that initiation of insulin therapy implies failure as a diabetic

9 Provider Concerns Fear of hypoglycemia Lack of time Concerns about patient compliance or competence Lack of comfort in dose titration Insulin s Place in Treatment Insulin can be used as early as second-line therapy in most Type 2 patients AACE recommends immediate initiation of insulin in symptomatic patients with A1c > 9% No medication is more effective in improving severe hyperglycemia than insulin 1 1. Irl B. Hirsch, et al. A Real-World Approach to Insulin Therapy in Primary Care Practice. Clinical Diabetes April 2005 vol. 23 no ADA Treatment Guide 1. Diabetes Care. Volume 39, Supplement 1, January 2016

10 AACE Treatment Guide Timely intensification of therapy has been shown to be associated with Better A1c control Importance of Early Insulin Initiation Delayed progression of diabetes disease process Reduced diabetes complications Reduced cardiovascular events Reduced microvascular complications 1. Holman et al. 10-year follow-up of intensive glucose control in Type 2 Diabetes. N Engl J Med 2008;359: Stratton et al. Association of glycaemia with macrovascular and microvascular complications of Type 2 Diabetes. BMJ 2000;321: It s Easier Than You Think Newer developments in basal insulin have simplified insulin therapy for the patient and the primary care provider Significantly less hypoglycemia Significantly fewer injections Significantly less weight gain Significantly less injection pain Dose titration can be simple and managed by most patients

11 Recent Developments Basal insulin recently got even easier with concentrated formulations Higher concentration allows for higher doses with lesser injection volume Less patient discomfort and insulin pens last longer Concentrated insulins tend to have longer duration of action and flatter basal profile Toujeo u/ml (glargine) Tresiba u/ml and 100 u/ml Dialing in the Dose Most patients can manage selftitration of insulin to help them reach goal Patients monitor fasting blood glucose (FBG) at home and adjust gradually until FBG goals are achieved Start at a low dose and make adjustments every few days, based on FBG readings Dialing in the Dose Titration algorithm example Start at 10 units daily of basal insulin. 1 or 2 times per week, adjust insulin dose based on lowest FBG level Lowest FBG Adjustment > units units No change <75-2 units

12 In the Hospital Generally, continuation of oral antidiabetic drugs is not advised in the hospital. Insulin is the treatment of choice NPH and long-acting basal insulins have similar efficacy in management of hyperglycemia, but NPH carries a greater risk of hypoglycemia Umpierrez G, et al. J Clin Endocrinol Metab. 2009; 94(2): Glycemic Goals During Hospitalization Glucose does not need to be as low in the hospital as in regular outpatient management No extra benefit to having BG < 120 mg/dl during the hospitalization Hypoglycemia during hospitalization is associated with increased risk of complications. Basal-Bolus therapy is more effective than Insulin Sliding Scales in maintaining glycemic goals 1 1. Umpierrez G, et al. Diabetes Care. 2007; 30(9): Glycemic Goals During Hospitalization Most patients' BG should be maintained between 140 and 180 mg/dl Adjust the target depending on the patient's clinical status for patients with terminal illness Reassess therapy it blood glucose drops below 100 mg/dl

13 Determining Initial Therapy New Admission to Hospital No previous insulin Insulin experienced Starting Total Daily Dose of 0.3 u/kg to 0.5 u/kg (Lower in elderly and renal insufficiency) Reduce outpatient dose by 20-25% Determining Initial Therapy Basal Only vs Basal-Bolus? NPO or Uncertain PO Intake New Patient Adequate PO Intake BASAL ONLY units/kg/day Correction doses if needed Adjust basal as needed BASAL/BOLUS units/kg/day 1/2 Basal, 1/2 Bolus (div) Adjust doses as needed Admission A1c Discharge Plan > 10% Add Basal or replace with Basal/Bolus > 9% Add Basal Insulin > 8% Adjust therapy. Add OAD or Basal Insulin < 7% Resume Original Therapy

14 Conclusion Clinical inertia and resistance to treatment intensification is a major factor limiting potential improvement in patient outcomes. More tools are currently available than ever before to help patients reach T2DM goals A strong understanding of the benefits and risks of available treatments will help both the patient and the provider make better decisions pertaining to therapy. Insulin is the most therapy for managing severe hyperglycemia and it's easier to use than ever.

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