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Pharmacological Management of Type 2 Diabetes (excluding insulin) These recommendations relate to glucose control where control is inadequate from lifestyle interventions Antidiabetic Drugs of Choice Concordance should always be determined before adding in additional drugs Class 1. Biguanide Formulary Choices Metformin Ist line: immediate release -500mg daily and gradually titrated to 2g per day in divided doses (or 3g per day under specialist supervision) 2nd line: modified release -initially 500mg OD, increased every 10-15 days, max 2g OD with evening meal Metformin oral powder-reserved for patients who cannot swallow the solid dosage form 2. Sulfonylureas Ist line: gliclazide -40-80mg daily, up to 160mg as a single dose, max 320mg daily 2nd line: gliclazide modified release -30mg daily, max 120mg daily 3. Acarbose Acarbose -50mg daily, increased to 50mg TDS, then increased if needed after 6-8 weeks to 100mg TDS, Comments/Notes -Metformin is the first line treatment for patients with type 2 diabetes -To minimise GI side effects, increase dose gradually over weeks and ensure tablets are taken with meals -Modified release: reserved for those who suffer with persistent GI side effects only after gradual titration with immediate release metformin -If oral powder is not suitable because of volume of liquid to be administered, a licensed oral solution is available (500mg/5ml). Unlicensed liquid ‘specials’ should be avoided. -Caution in renal impairment. NICE recommends that the dose should be reviewed if serum creatinine exceeds 130 micromol/L or eGFR is less than 45 ml/minute/1.73m2. Stop metformin if the serum creatinine exceeds 150 micromol/L or eGFR is less than 30 ml/minute/1.73m2. -Note that metformin has been associated with a significant reduction in MI and stroke rates in patients with type 2 diabetes as well as a significant reduction in mortality. -Consider as a first line option for patients who are not overweight. Use in combination with metformin, or use instead of metformin if not tolerated or contraindicated, or use with other agents. Add to metformin if blood glucose control remains or becomes inadequate. -Start at low dose. Maximum dosage should be avoided particularly in combination with other glucose lowering medication -Modified release-only for patients with hectic lifestyle to improve compliance -Avoid glibenclamide-long acting and greater risk of hypoglycaemia -Consider when other glucose-lowering medications are contra-indicated or not tolerated -Titrate dose slowly to reduce incidence of GI Date approved: November 2013 Approved by: Medicines Management Committee Review date: November 2014, or earlier as appropriate 1 max 200mg TDS adverse effects 4. Rapid-acting 1st line: repaglinide -Consider in those with an erratic lifestyle, insulin -500mcg 30 minutes before main when lifestyle limits the use of sulfonylurea secretagogues meal, increased up to four times daily (30 minutes before food), individual doses can be increased to max 4mg as a single dose, max total dose is 16mg daily 5. Glitazones -Prescribing of pioglitazone should be in line with MHRA/CHM advice (cardiovascular (thiazolidinedi safety, December 2007 and January 2011, and risk of bladder cancer July 2011) ones) -Pioglitazone should not be used in patients with heart failure or a history of heart failure -Pioglitazone should not be used in patients with active bladder cancer or a past history of bladder cancer, or in those who have uninvestigated macroscopic haematuria. Pioglitazone should be used with caution in elderly patients as the risk of bladder cancer increases with age -Pioglitazone should not be used in people who are at higher risk of fracture Pioglitazone-specialist -May be preferable if the person has marked recommendation insulin insensitivity -15-45mg OD -NICE recommend to continue only if there is a reduction ≥ 0.5% points in HbA1c in 6 months (between 5 and 6 mmol/mol). However, because of its potential long term adverse effects consider continuing long term treatment only in those with robust responses (> 11mmol/mol, >1% points in HbA1c) particularly where other treatments have proven ineffective. Please consider the use of metformin or a sulfonylurea where appropriate prior to the use of a DPP4 inhibitor, SGLT2 inhibitor or GLP-1 receptor agonist 6. DPP4 Ist line: saxagliptin -Consider saxagliptin instead of a sulfonylurea inhibitors-5mg OD as second line therapy when control of blood gliptins glucose remains or becomes inadequate and 2nd line: linagliptin (only if patient person is at significant risk of hypoglycaemia or has renal impairment) sulfonylurea not tolerated or contraindicated -5mg OD -Consider adding saxagliptin to sulfonylurea as second-line therapy when control of blood Non-formulary: sitagliptin, glucose remains or becomes inadequate and metformin not tolerated or contraindicated vildagliptin -Consider adding saxagliptin to metformin and a sulfonylurea when control of blood glucose remains or becomes inadequate -Continue gliptin only if there is a reduction of ≥0.5% points in HbA1c in 6 months (between 5 and 6 mmol/mol) -Saxagliptin: Reduce dose to 2.5mg OD in moderate to severe renal impairment (caution in patients with severe renal impairment (consider use of linagliptin in these circumstances) -Linagliptin: No dose adjustment required in renal impairment -Dose of concomitant sulfonylurea or insulin may need to be reduced. Date approved: November 2013 Approved by: Medicines Management Committee Review date: November 2014, or earlier as appropriate 2 7. SGLT2 inhibitor Dapagliflozin -10mg OD 8. GLP-1 receptor Ist line: lixisenatide agonists -10mcg sc OD for 14 days, increased to 20mcg OD 2nd line: Bydureon (exenatide) modified release, if patient does not tolerate lixisenatide -2mg sc once weekly Patients with a suboptimal response (not quite reaching NICE criteria) to lixisenatide but not suitable for Bydureon: liraglutide -0.6-1.2mg sc OD (1.8mg OD is not recommended by NICE) Non-formulary: Byetta (exenatide) -Caution if prescribing gliptins in patients with a history of heart failure. An increased risk of hospitalisation for heart failure was noted in recent clinical trials (though no increase in mortality was seen). If overt signs of heart failure develop then gliptin medication should be withdrawn. -Gliptins should be considered prior to the use of dapaglifozin -To be used in line with NICE TA228: -For use as dual therapy in combination with metformin -For use in combination with insulin with or without other antidiabetic drugs -NICE does not recommended use as triple therapy with metformin and a sulfonylurea -NICE does not recommended use with pioglitazone -Continue only if there is a reduction of ≥0.5% points in HbA1c in 6 months (between 5 and 6 mmol/mol) -Dose of concomitant insulin or sulfonylurea may need to be reduced -Check renal function before treatment and at least annually -Not recommended in moderate to severe renal failure (eGFR<60ml/minute) -Common side effects: dyslipidaemia, back pain, genital infections, UTI, dysuria, polyuria -Lixisenatide can be used in combination with oral antidiabetic drugs (metformin, sulphonylurea or pioglitazone) and/or basal insulin -Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia -Dose of concomitant sulfonylurea or insulin may need to be reduced with gliptin -Lixisenatide is not recommended in severe renal impairment (eGFR <30 ml/minute) -Bydureon is not recommended in moderate to severe renal impairment (eGFR <50 ml/minute) -Liraglutide is not recommended if eGFR <60 ml/minute) -Patients with no or very little response to one GLP-1 receptor agonist should not be offered another one. However, if a partial response to lixisenatide (HbaA1c reduction >5 but <11mmol/mol and weight loss of >1.5% but less than 3% body weight) is seen, then consider switching to Bydureon or liraglutide if there are strong reasons to persist with GLP-1 receptor Date approved: November 2013 Approved by: Medicines Management Committee Review date: November 2014, or earlier as appropriate 3 agonist therapy. -Severe pancreatitis (sometimes fatal) has been reported rarely with exenatide. Patients or their carers should be told how to recognise signs and symptoms of pancreatitis and advised to seek prompt medical attention if symptoms such as abdominal pain, nausea, and vomiting develop; discontinue permanently if pancreatitis is diagnosed. Pancreatitis is much commoner in patients with diabetes and it is not clear if the reported cases of pancreatitis merely reflect this or if the true rate of pancreatitis is increased. An increased rate of pancreatitis has not been seen in clinical trials. Lixisenatide, Bydureon (exenatide) modified release and liraglutide recommendations (NICE): Triple therapy -Can be used in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and pioglitazone), and the person should have an HbA1c of 59 mmol/mol (7.5%) or above, with: a BMI ≥ 35 kg/m2 in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities -Only continue treatment if a reduction of at least 1% in HbA1c (11 mmol/mol) and a weight loss of at least 3% of initial body weight is achieved at 6 months Lixisenatide, Bydureon (exenatide) modified release and liraglutide recommendations (NICE): Dual therapy -Can be used in dual therapy regimens (in combination with metformin or a sulphonylurea), only if the person is intolerant of either metformin or a sulphonylurea, or metformin or a sulphonylurea is contraindicated, and the person is intolerant of thiazolidinediones and DPP-4 inhibitors, or thiazolidinediones and DPP4 inhibitors is contraindicated -Only continue treatment if a reduction of at least 1% in HbA1c (11 mmol/mol) is achieved at 6 months Date approved: November 2013 Approved by: Medicines Management Committee Review date: November 2014, or earlier as appropriate 4