Update on Therapies for Type 2 Diabetes: Angela D. Mazza, DO July 31, 2015

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1 Update on Therapies for Type 2 Diabetes: 2015 Angela D. Mazza, DO July 31, 2015

2 Objectives To present the newer available therapies for the management of T2D To discuss the advantages and disadvantages of these newer treatments To discuss the efficacy of combination therapies

3 Standards of Medical Care in Diabetes 2015 American Diabetes Association Dia Care 2015;38:S41-S48

4 Incretin effect Difference in amount of insulin secreted in response to oral glucose load compared to intravenous glucose administration Plasma glucose levels are similar between oral and IV administration Oral administration produces an increase in insulin secretory response Incretin effect is diminished or absent in persons with T2D Garber AJ. Diabetes Care 2011;34:S279-S284.

5 Adapted from Tanaka et al. Kidney International 86, (October 2014)

6 DPP-4 Inhibitors Sitagliptin (Januvia) Saxagliptin (Onglyza) Linagliptin (Tradjenta) Alogliptin (Nesina) 100 mg QD to 50 or 25 mg QD only for renal dysfunction 5 mg QD to 2.5 mg QD in CrCl<50 or with CYP3A4 inhibitor More drug-drug interactions 5 mg QD Potential hyperuricemia and hyperlipidemia 25 mg QD to 12.5 or 6.25 mg QD in renal dysfunction Hepatotoxicity seen in postmarketing data Acceptable for use in patients with hepatic and renal dysfunction Oral tablet taken once daily with or without food Post-marketing reports of acute pancreatitis

7 DPP-4 Inhibitors and Heart Failure SAVOR TIMI 53 Trial Hospitalization for heart failure statistically significant in saxagliptin arm EXAMINE Trial Increased hospitalizations for heart failure in alogliptin arm; not statistically significant TECOS Trial Does sitagliptin increase hospitalizations for heart failure? We ll see. Add citations

8 DPP-4 Inhibitors Risks Benefits

9 Short-Acting GLP-1 Receptor Agonists Exenatide (Byetta) Liraglutide (Victoza) 5-10 mcg BID within 60 minutes of a meal Titrate dose after 30 days Only GLP-1RA not associated with thyroid cancer mg QD 0.6 mg ineffective for glycemic control Titrate to 1.2 mg QD after 1 week Slow titration due to GI effects Contraindicated in GI disease Best use is for post-prandial control Drug-drug interactions: NTI meds, oral abx, pain meds, and contraceptives

10 Once Weekly GLP-1 RA Exenatide LAR (Bydureon) Albiglutide (Tanzeum) Dulaglutide (Trulicity) 2 mg/week Steady state: 6 weeks Injection site nodules Increased INR mg/week Steady state: 4-5 weeks mg/week Steady state: 2-4 weeks No-see needle Less GI side effects with once weekly May be taken without regard to meals Missed dose: 3-day grace period Possible increased risk of pancreatitis and thyroid cancer Drug-drug interactions: NTI meds, oral abx, pain meds, and contraceptives

11 Indirect Comparison of GLP-1RA Therapies Agent Change in A1C (%) Exenatide to 1.5 Liraglutide to Exenatide LAR -1.9 Albiglutide Dulaglutide -1.52

12 GLP-1 Receptor Agonists Risks Benefits

13 SGLT2 Inhibitors Bowman s capsule Proximal Convoluted Tubule Filtered glucose SGLT2 SGLT1 90% of glucose reabsorbed 10% of glucose reabsorbed

14 SGLT2 Inhibitors Canagliflozin (Invokana) Dapagliflozin (Farxiga) Empagliflozin (Jardiance) mg QAM Hyperkalemia egfr: <45mL/min/1.73 m² 5-10 mg QAM Bladder cancer egfr: <60mL/min/1.73 m² mg QAM egfr: <45 ml/min/1.73 m² Increased risk of genital mycotic infections Increased risk of hypotension, renal insufficiency, and dehydration Weight loss is an added benefit Kidneys have to be functioning for efficacy

15 SGLT2 Inhibitors Risks Benefits Mycotic genital infections Renal insufficiency Dehydration Weight loss Lowered blood pressure % A1c reduction

16 New Insulin Glargine: Basaglar Same amino acid chain as Lantus, but submitted via 505(b)(2) Granted tentative FDA-approval August 2014 Meets all regulatory requirements for approval Final approval not possible until litigation s resolution

17 Glargine U-300 (Toujeo) Flatter and longer profile of action than glargine U-100 Onset of action: 6 hours Maximum glucose lowering effect: up to 5 days More concentrated, smaller depot Glargine U-100 Glargine U-300

18 Glargine U-300 (Toujeo) Switching from: Recommended Glargine U-300 dose Comments Glargine U-100 1:1 conversion Higher dose of glargine U- 300 will likely be needed NPH 80% of total NPH dose as single daily dose Disposable, pre-filled pen device with 1.5 ml of solution 450 units per pen

19 Inhaled Insulin: Afrezza Dry powder, regular insulin Available in 2 cartridge strengths Blue: 4 units (0.35 mg insulin) Green: 8 units (0.7 mg insulin) Breath-powered by patient A1C reduction: 0.4%

20 Inhaled Insulin: Afrezza Inhaled insulin has faster absorption than rapid acting insulin, but onset of activity is comparable Maximum serum insulin concentration: minutes Peak: within 30 minutes Duration: 3 hours Adverse effects: Hypoglycemia (severe: 5.1% treatment vs. 1.7% placebo) Cough (27% treatment vs. 5.2% placebo) Throat pain or irritation Pulmonary function decline (40 ml decline in FEV1) Acute bronchospasm in patients with chronic lung disease

21 Inhaled Insulin Dose Conversion Injected bolus insulin dose Recommended inhaled insulin dose <4 units 4 units 5-8 units 8 units 9-12 units 12 units units 16 units units 20 units units 24 units

22 Inhaled Insulin: Afrezza Acute bronchospasm has been observed in patients with asthma and COPD. Contraindicated in patients with chronic lung disease. Don t use in smokers. Before initiating, perform detailed medical history and physical with spirometry to identify potential lung disease FEV1 should be performed at baseline, 6 months, and then periodically with use of inhaled insulin.

23 Inhaled Insulin Tips Bolus insulin only Packaged as 90 cartridges with 2 inhalers Inhaler should be replaced every 15 days. Cartridges should be at room temp for at least 10 minutes prior to use Powder residue in the mouth piece is normal

24 Combinations To Avoid Meglitinide and sulfonylurea: same action DPP-4 inhibitor and GLP-1 RA: insufficient data SGLT2 inhibitor and GLP-1 RA: insufficient data

25 Efficacy as Add-on to Metformin Agent Difference from metformin (adjusted mean): 95% CI % achieving A1C <7% with addition to metformin Actos 0.8 Not available Januvia Onglyza Tradjenta Nesinia Byetta Bydureon Not available 58 Victoza Trulicity Not available 59 Tanzeum Invokana Farxiga Jardiance

26 Specific Patient Populations Renal impairment Heart failure Mild-moderate liver impairment Obesity DPP-4 inhibitors (adjusted, except linagliptin Glimepiride GLP-1 RA TZDs DPP-4 inhibitor? GLP-1 RA SGLT2 inhibitor Sulfonylurea DPP-4 inhibitor (caution alogliptin) SGLT2 inhibitor GLP-1 RA SGLT2 inhibitor

27 In the pipeline

28 Phase III Clinical Trials DPP-4 Inhibitors SGLT2 Inhibitors GLP-1 RA Omarigliptin (Merck): Once weekly agent Ertugliflozin (Pfizer/Merck) Lixisenatide (Lyxumia) (Sanofi Aventis) Semaglutide (Novo Nordisk) LATIN T!D (Novo Nordisk)

29 Phase III Clinical Trials Insulin Peglispro (Lily) Faster-acting insulin aspart (FlAsp) (Novo Nordisk) Insulin degludec (Tresiba) (Novo Nordisk) Insulin degludec + insulin aspart (Ryzodeg) (Novo Nordisk) Insulin degludec + liraglutide (DegLira) (Novo Nordisk)

30 Considerations to individualize patient therapy: Past medical history and concomitant disease states Agents with complementary mechanism of action Ability to use delivery devices Patient-specific advantages to use (ie BP lowering, weight loss, etc.) A1C lowering necessary to achieve goal

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