Management of Hyperglycemia in Type 2 Diabetes, 2015: A Patient-Centered Approach

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1 Management of Hyperglycemia in Type 2 Diabetes, 2015: A Patient-Centered Approach Update to a Position Statement of the American Diabetes Association (ADA) and the European Association f the Study of Diabetes (EASD) Diabetes Care 2015;38: Diabetologia 2015;58:

2 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, 2015 Writing Group American Diabetes Association Richard M. Bergenstal MD Int l Diabetes Center, Minneapolis, MN John B. Buse MD, PhD University of Nth Carolina, Chapel Hill, NC Anne L. Peters MD Univ. of Southern Califnia, Los Angeles, CA Richard Wender MD Thomas Jefferson University, Philadelphia, PA Silvio E. Inzucchi MD (co-chair) Yale University, New Haven, CT European Assoc. f the Study of Diabetes Michaela Diamant MD, PhD (posthumous) VU University, Amsterdam, The Netherlands Ele Ferrannini MD University of Pisa, Pisa, Italy Michael Nauck MD Diabeteszentrum, Bad Lauterberg, Germany Apostolos Tsapas MD, PhD Aristotle University, Thessaloniki, Greece David R. Matthews MD, DPhil (co-chair) Oxfd University, Oxfd, UK Diabetes Care 2015;38: ; Diabetologia 2015;58:

3 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, PATIENT-CENTERED CARE 2. BACKGROUND Epidemiology and health care impact Relationship of glycemic control to outcomes Overview of the pathogenesis of Type 2 diabetes 3. ANTI-HYPERGLYCEMIC THERAPY Glycemic targets Therapeutic options - Lifestyle - Oral agents & non-insulin injectables - Insulin Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

4 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTIHYPERGLYCEMIC THERAPY Implementation Strategies - Initial drug therapy - Advancing to dual combination therapy - Advancing to triple combination therapy - Transitions to and titrations of insulin 4. OTHER CONSIDERATIONS Age Weight Sex/racial/ethnic/genetic differences Combidities (CAD, HF, CKD, Liver disease, Hypoglycemia-prone) 5. FUTURE DIRECTIONS / RESEARCH NEEDS Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

5 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, Patient-Centered Approach...providing care that is respectful of and responsive to individual patient preferences, needs, and values - ensuring that patient values guide all clinical decisions. Gauge patient s preferred level of involvement. Exple, where possible, therapeutic choices. Consider using decision aids. Shared Decision Making a collabative process between patient and clinician, using best available evidence and taking into account the patient s preferences and values Final decisions regarding lifestyle choices ultimately lie with the patient. Diabetes Care 2012;35: ; Diabetologia 2012;55:

6 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, BACKGROUND Relationship of glycemic control to microvascular and macrovascular outcomes. Diabetes Care 2012;35: ; Diabetologia 2012;55:

7 Impact of Intensive Therapy f Diabetes: Summary of Maj Clinical Trials Study Microvasc CVD Mtality UKPDS DCCT / EDIC* ACCORD ADVANCE VADT Kendall DM, Bergenstal RM. International Diabetes Center 2009 UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854. Holman RR et al. N Engl J Med. 2008;359:1577. DCCT Research Group. N Engl J Med 1993;329;977. Nathan DM et al. N Engl J Med. 2005;353:2643. Gerstein HC et al. N Engl J Med. 2008;358:2545. Patel A et al. N Engl J Med 2008;358:2560. Duckwth W et al. N Engl J Med 2009;360:129. (erratum: Mitz T. N Engl J Med 2009;361:1024) Initial Trial Long Term Fol-up * in T1DM

8 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, BACKGROUND Overview of the pathogenesis of T2DM - Insulin secrety dysfunction - Insulin resistance (muscle, fat, liver) - Increased endogenous glucose production - Decreased incretin effect - Deranged adipocyte biology Diabetes Care 2012;35: ; Diabetologia 2012;55:

9 Multiple, Complex Pathophysiological Abnmalities in T2DM incretin effect gut carbohydrate delivery & absption _ pancreatic insulin secretion pancreatic glucagon secretion HYPERGLYCEMIA _? hepatic glucose production renal glucose excretion peripheral glucose uptake Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011

10 Multiple, Complex Pathophysiological Abnmalities in T2DM GLP-1R agonists Insulin Glinides S U s incretin effect DPP-4 inhibits Amylin mimetics _ AGIs gut carbohydrate delivery & absption pancreatic insulin secretion pancreatic glucagon secretion DA? agonists HYPERGLYCEMIA Metfmin _ Bile acid sequestrants hepatic glucose production renal glucose excretion s peripheral glucose uptake Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011

11 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTI-HYPERGLYCEMIC THERAPY Glycemic targets - HbA1c < 7.0% (mean PG mg/dl [ mmol/l]) - Pre-prandial PG <130 mg/dl (7.2 mmol/l) - Post-prandial PG <180 mg/dl (10.0 mmol/l) - Individualization is key: Tighter targets ( %) - younger, healthier Looser targets ( % ) - older, combidities, hypoglycemia prone, etc. - Avoidance of hypoglycemia PG = plasma glucose Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

12 Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM PATIENT / DISEASE FEATURES Risks potentially associated with hypoglycemia and other drug adverse effects me stringent Approach to the management of hyperglycemia HbA1c 7% less stringent Disease duration newly diagnosed long-standing Life expectancy long sht Usually not modifiable Imptant combidities absent few / mild severe Established vascular complications absent few / mild severe Patient attitude and expected treatment effts ly motivated, adherent, excellent self-care capacities less motivated, non-adherent, po self-care capacities Potentially modifiable Resources and suppt system Readily available limited Diabetes Care 2015;38: ; Diabetologia 2015;58:

13 Approach to the Management of Hyperglycemia Risks potentially associated with hypoglycemia, other drug adverse effects me stringent Low Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM HbA1c 7% less stringent High Diabetes Care 2012;35: Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

14 Approach to the Management of Hyperglycemia me stringent Disease duration Newly diagnosed Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM HbA1c 7% less stringent Long-standing Diabetes Care 2012;35: Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

15 Approach to the Management of Hyperglycemia me stringent Life expectancy Long Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM HbA1c 7% less stringent Sht Diabetes Care 2015;38: ; Diabetologia 2015;58:

16 Approach to the Management of Hyperglycemia me stringent Imptant combidities Absent Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM HbA1c 7% Few / Mild less stringent Severe Diabetes Care 2015;38: ; Diabetologia 2015;58:

17 Approach to the Management of Hyperglycemia me stringent Established vascular complications Absent Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM HbA1c 7% Few / Mild less stringent Severe Diabetes Care 2015;38: ; Diabetologia 2015;58:

18 Approach to the Management of Hyperglycemia me stringent Patient attitude & expected treatment effts HbA1c 7% Highly motivated, adherent, excellent self-care capacities less stringent Less motivated, non-adherent, po self-care capacities P O T E N T I A L LY MODIFIABLE Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM Diabetes Care 2015;38: ; Diabetologia 2015;58:

19 Approach to the Management of Hyperglycemia me stringent Resources and suppt systems HbA1c 7% Readily available less stringent Limited P O T E N T I A L LY MODIFIABLE Figure 1. Modulation of the intensiveness of glucose ering therapy in T2DM Diabetes Care 2015;38: ; Diabetologia 2015;58:

20 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Lifestyle - Weight optimization - Healthy diet - Increased activity level Diabetes Care 2012;35: ; Diabetologia 2012;55:

21 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Oral agents & non-insulin injectables - Metfmin - Sulfonylureas - Thiazolidinediones - DPP-4 inhibits - SGLT-2 inhibits - Meglitinides - -glucosidase inhibits - Colesevelam - Dopamine-2 agonists - Amylin mimetics - GLP-1 recept agonists Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

22 Oral Class Mechanism Advantages Disadvantages Cost Biguanides Sulfonylureas Meglitinides 015;38: ; Activates AMPkinase (?other) Hepatic glucose production Closes K ATP channels Insulin secretion Closes K ATP channels Insulin secretion Extensive experience No hypoglycemia Weight neutral? CVD Extensive experience Microvascular risk Postprandial glucose Dosing flexibility Gastrointestinal Lactic acidosis (rare) B-12 deficiency Contraindications Hypoglycemia Weight Low durability? Blunts ischemic preconditioning Hypoglycemia Weight? Blunts ischemic preconditioning Dosing frequency Low Low Mod. s PPAR- activat Insulin sensitivity No hypoglycemia Durability TGs (pio) HDL-C? CVD events (pio) Weight Edema/heart failure Bone fractures LDL-C (rosi)? MI (rosi) Low Table 1. Properties of anti-hyperglycemic agents Diabetes Care 2015;38: ; Diabetologia 2015;58:

23 Oral Class Mechanism Advantages Disadvantages Cost -Glucosidase inhibits DPP-4 inhibits Bile acid sequestrants Dopamine-2 agonists SGLT2 inhibits Inhibits -glucosidase Ss carbohydrate digestion / absption Inhibits DPP-4 Increases incretin (GLP-1, GIP) levels Bind bile acids? Hepatic glucose production Activates DA recept Alters hypothalamic control of metabolism insulin sensitivity Inhibits SGLT2 in proximal nephron Increases glucosuria No hypoglycemia Nonsystemic Postprandial glucose? CVD events No hypoglycemia Well tolerated No hypoglycemia LDL-C No hypoglyemia? CVD events Weight No hypoglycemia BP Effective at all stages Gastrointestinal Dosing frequency Modest A1c Angioedema / urticaria? Pancreatitis? Heart failure Gastrointestinal Modest A1c Dosing frequency Modest A1c Dizziness, fatigue Nausea Rhinitis GU infections Polyuria Volume depletion LDL-C Cr (transient) Mod. High High High High Table 1. Properties of anti-hyperglycemic agents Diabetes Care 2015;38: ; Diabetologia 2015;58:

24 Injectabl e Class Amylin mimetics GLP-1 recept agonists Insulin Mechanism Advantages Disadvantages Cost Activates amylin recept glucagon gastric emptying satiety Activates GLP-1 R Insulin, glucagon gastric emptying satiety Activates insulin recept Myriad Weight Postprandial glucose Weight No hypoglycemia Postprandial glucose Some CV risk facts Universally effective Unlimited efficacy Microvascular risk Table 1. Properties of anti-hyperglycemic agents Gastrointestinal Modest A1c Injectable Hypo if insulin dose not reduced Dosing frequency Training requirements Gastrointestinal? Pancreatitis Heart rate Medullary ca (rodents) Injectable Training requirements Hypoglycemia Weight? Mitogenicity Injectable Patient reluctance Training requirements High High Variable Diabetes Care 2015;38: ; Diabetologia 2015;58:

25 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Combination injectable therapy If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Figure 2. Anti-hyperglycemic therapy Basal Insulin Mealtime Insulin in T2DM: General recommendations Diabetes Care 2015;38: ; Diabetologia 2015;58:

26 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Combination injectable therapy If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Figure 2. Anti-hyperglycemic therapy Basal Insulin Mealtime Insulin in T2DM: General recommendations Diabetes Care 2015;38: ; Diabetologia 2015;58:

27 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Combination injectable therapy If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Figure 2. Anti-hyperglycemic therapy Basal Insulin Mealtime Insulin in T2DM: General recommendations Diabetes Care 2015;38: ; Diabetologia 2015;58:

28 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Combination injectable therapy If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Basal Insulin Metfmin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015;58:

29 Monotherapy Efficacy * Hypo risk Weight Side effects Metfmin Costs intolerance contraindication HbA1c 9% Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Uncontrolled hyperglycemia (catabolic features, BG mg/dl, HbA1c 10-12%) Combination injectable therapy Basal Insulin If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015;58:

30 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Figure 2A. Anti-hyperglycemic Combination therapy injectable in T2DM: Basal Insulin Mealtime Insulin Avoidance therapy of hypoglycemia Diabetes Care 2015;38: ; Diabetologia 2015;58:

31 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) Figure 2B. Anti-hyperglycemic Combination therapy injectable in T2DM: Avoidance therapy of weight If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Basal Insulin Metfmin Mealtime Insulin Diabetes Care 2015;38: ; Diabetologia 2015;58:

32 Monotherapy Efficacy * Hypo risk Weight Side effects Costs Dual therapy Efficacy * Hypo risk Weight Side effects Costs Healthy eating, weight control, increased physical activity & diabetes education Metfmin neutral/loss GI / lactic acidosis If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Sulfonylurea moderate risk hypoglycemia Metfmin Thiazolidinedione edema, HF, fxs Metfmin DPP-4 inhibit intermediate neutral rare Metfmin SGLT2 inhibit intermediate loss GU, dehydration Metfmin GLP-1 recept agonist loss GI Metfmin Insulin (basal) est risk hypoglycemia variable Triple therapy Metfmin Sulfonylurea If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (der not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific facts): Metfmin Thiazolidinedione Metfmin DPP-4 Inhibit Metfmin SGLT-2 Inhibit Metfmin GLP-1 recept agonist Metfmin Insulin (basal) If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on al combination, move to injectables, (2) on GLP-1 RA, add basal insulin, (3) on optimally titrated basal insulin, add mealtime insulin. In refracty patients consider adding SGL T2-i: Metfmin Figure 2C. Anti-hyperglycemic Combination therapy injectable in T2DM: Basal Insulin Mealtime Insulin Minimization therapy of costs Diabetes Care 2015;38: ; Diabetologia 2015;58:

33 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Insulins Human Insulins - Neutral protamine Hagedn (NPH) - Regular human insulin - Pre-mixed fmulations Insulin Analogues - Basal analogues (glargine, detemir, degludec) - Rapid analogues (lispro, aspart, glulisine) - Pre-mixed fmulations Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

34 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Insulins Rapid (Lispro, Aspart, Glulisine) Insulin level Sht (Regular) Long (Detemir) Long (Glargine) (Degludec) Hours Hours after injection

35 Figure 3. Approach to starting & adjusting insulin in T2DM Basal Insulin (usually with metfmin /- other non-insulin agent) Start: 10U/day U/kg/day Adjust: 10-15% 2-4 U once-twice weekly to reach FBG target. F hypo: Determine & address cause; dose by 4 units 10-20%. Diabetes Care 2015;38: ; Diabetologia 2015;58:

36 Figure 3. Approach to starting & adjusting insulin in T2DM Basal Insulin (usually with metfmin /- other non-insulin agent) Start: 10U/day U/kg/day Adjust: 10-15% 2-4 U once-twice weekly to reach FBG target. F hypo: Determine & address cause; dose by 4 units 10-20%. Add 1 rapid insulin* injections befe largest meal If not controlled after FBG target is reached ( if dose > 0.5 U/kg/day), treat PPG excursions with meal-time insulin. (Consider initial trial.) Change to premixed insulin* twice daily Start: 4U, 0.1 U/kg, 10% basal dose. If A1c<8%, consider basal by same amount. Adjust: dose by 1-2 U 10-15% oncetwice weekly until SMBG target reached. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. Start: Divide current basal dose into 2/3 AM, 1/3 PM 1/2 AM, 1/2 PM. Adjust: dose by 1-2 U 10-15% oncetwice weekly until SMBG target reached. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. If not controlled, consider basalbolus. Add 2 rapid insulin* injections befe meals ('basal-bolus ) Start: 4U, 0.1 U/kg, 10% basal dose/meal. If A1c<8%, consider basal by same amount. Adjust: dose by 1-2 U 10-15% once-twice weekly to achieve SMBG target. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. If not controlled, consider basalbolus. Diabetes Care 2015;38: ; Diabetologia 2015;58:

37 Figure 3. Approach to starting & adjusting insulin in T2DM # Injections 1 Basal Insulin (usually with metfmin /- other non-insulin agent) Start: 10U/day U/kg/day Adjust: 10-15% 2-4 U once-twice weekly to reach FBG target. F hypo: Determine & address cause; dose by 4 units 10-20%. Complexity 2 Add 1 rapid insulin* injections befe largest meal If not controlled after FBG target is reached ( if dose > 0.5 U/kg/day), treat PPG excursions with meal-time insulin. (Consider initial trial.) Change to premixed insulin* twice daily mod. Start: 4U, 0.1 U/kg, 10% basal dose. If A1c<8%, consider basal by same amount. Start: Divide current basal dose into 2/3 AM, 1/3 PM 1/2 AM, 1/2 PM. Adjust: dose by 1-2 U 10-15% oncetwice weekly until SMBG target reached. Adjust: dose by 1-2 U 10-15% oncetwice weekly until SMBG target reached. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. 3 If not controlled, consider basalbolus. Add 2 rapid insulin* injections befe meals ('basal-bolus ) If not controlled, consider basalbolus. Start: 4U, 0.1 U/kg, 10% basal dose/meal. If A1c<8%, consider basal by same amount. Adjust: dose by 1-2 U 10-15% once-twice weekly to achieve SMBG target. F hypo: Determine and address cause; cresponding dose by 2-4 U 10-20%. Diabetes Care 2015;38: ; Diabetologia 2015;58: Flexibility me flexible less flexible

38 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, OTHER CONSIDERATIONS Age Weight Sex / racial / ethnic / genetic differences Combidities - Conary artery disease - Heart Failure - Chronic kidney disease - Liver dysfunction - Hypoglycemia-prone Diabetes Care 2012;35: ; Diabetologia 2012;55:

39 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, FUTURE DIRECTIONS / RESEARCH NEEDS Comparative effectiveness research Focus on imptant clinical outcomes Contributions of genomic research Perpetual need f clinical judgment! Diabetes Care 2012;35: ; Diabetologia 2012;55:

40 ADA-EASD Position Statement Update: Management of Hyperglycemia in T2DM, 2015 KEY POINTS Glycemic targets & BG-ering therapies must be individualized, based on a variety of patient and disease characteristics. Diet, exercise, & education: foundation of any T2DM therapy program. Unless contraindicated, metfmin remains the optimal first-line drug. After metfmin, data are limited. Combination therapy with 1-2 other al / injectable agents is reasonable. Try to minimize side effects. Ultimately, many patients will require insulin therapy alone in combination with other agents to maintain BG control. All treatment decisions should be made in conjunction with the patient (focusing on his her preferences, needs & values.) Comprehensive CV risk reduction - a maj focus of therapy. Diabetes Care 2012;35: ; Diabetologia 2012;55: Diabetes Care 2015;38: ; Diabetologia 2015;58:

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