667FM.5.1 MANAGEMENT OF TYPE 2 DIABETES: BLOOD-GLUCOSE-LOWERING THERAPY

Transcription

1 667FM.5.1 MANAGEMENT OF TYPE 2 DIABETES: BLOOD-GLUCOSE-LOWERING THERAPY Contents Introduction... 1 Patient Education for People with Type 2 Diabetes... 2 Dietary Advice for People with Type 2 Diabetes... 2 Self-monitoring... 2 Blood Glucose Lowering/Treatment Intensification... 3 General guidance on intensification... 3 Oral treatment... 4 Oral agents: Quick reference for selecting an agent... 5 Injectable treatment... 6 Structured Education when Initiating a GLP-1 or Insulin Therapy... 7 Starting Insulin Therapy in People with Type 2 Diabetes... 8 References... 9 Appendix 1: Patient Information on Home Blood Glucose Testing in Type 2 Diabetes Introduction In December 2015, NICE updated its clinical guideline on Type 2 Diabetes (NG28). This encompasses all aspects of patient management including not only blood glucose control but also lipid management, anti-thrombotic therapy and blood pressure control. This clinical guideline represents the local adaptation of the above NICE guideline in relation to blood-glucose-lowering therapy and was developed in collaboration between Buckinghamshire Healthcare Trust (BHNSHT) and Buckinghamshire Clinical Commissioning Group. The application of the recommendations in this guideline should always be considered alongside the individual clinical need and personal preferences of the patient. Clinical support is available from the Community DSN Advice and Guidance telephone line: (Monday - Friday 10-16:00 hours). All supporting documents mentioned in the guideline can be found on the Medicines Management website: See also: Guideline 109FM Glucagon-Like Peptide-1 (GLP-1) Agonists for Adults with Type 2 Diabetes Guideline 667FM of 11 Uncontrolled if printed

2 Patient Education for People with Type 2 Diabetes Structured education is an integral part of diabetes care and patients and carers should be informed of this offer at the time of diagnosis, with annual reinforcement and review. Referral to online and face to face structured education can be done through the Live Well, Stay Well website or by healthcare professionals (HCPs) making a referral by . Dietary Advice for People with Type 2 Diabetes Provide in a form that is sensitive to the person s needs, culture and beliefs, being sensitive to their willingness to change, and effects on their quality of life. Integrate with diabetes management plan, including other aspects of lifestyle modification, such as increasing physical activity. Discourage use of foods marketed specifically for people with diabetes. Include in Discussion General advice for healthy eating: include high-fibre, low-glycaemic index sources of carbohydrate include low-fat dairy products and oily fish control the intake of foods containing saturated fats and trans fatty acids. Limited substitution of sucrose containing foods for other carbohydrate is allowable, but care should be taken to avoid excess energy intake. Refer using local dietetics pathway if further help needed. Action Provide individualised and ongoing nutritional advice from a healthcare professional with specific expertise and competencies in nutrition. Individualise recommendations for carbohydrate and alcohol intake, and meal patterns aim to reduce risk of hypoglycaemia, particularly if using insulin or insulin secretagogues. Initial body weight loss target = 5 10% in an overweight person: lesser amounts are still beneficial losing more weight in the longer term has metabolic benefits. Special Circumstances Special needs for inpatients with type 2 diabetes will be dealt with by dieticians. Self-monitoring Please refer to the CCG Patient Information on Home Blood Glucose Testing in Type 2 Diabetes leaflet (appendix 1) for ongoing monitoring information. Agree level and ongoing frequency of monitoring requirements; with each individual patient when on an insulin secretagogue or insulin. Testing may also be required when patient is on steroid therapy or to assess post prandial blood glucose readings (see above). Guideline 667FM of 11 Uncontrolled if printed

3 Blood Glucose Lowering/Treatment Intensification General guidance on intensification Initiation: Start treatment if HbA1c >48 mmol/mol note if HbA1c is very high (e.g. >75 mmol/mol)/patient has significant osmotic symptoms/acute or sub-acute onset over weeks ensure that the diagnosis is type 2 diabetes. Temporary treatment with insulin may be necessary *. Individualise HbA1c (see below) - set goals for each patient. Following diagnosis HbA1c should be done at 3 months after each intensification until individual goal of HbA1c reached see above. Consider checking HbA1c every 6-12 months, once stable. If there is a discrepancy between self-monitoring and HbA1c, and in scenarios where HbA1c may not be reliable (see page 4), seek advice from community DSNs/Diabetes Centre at Buckinghamshire Healthcare NHS Trust. For individual drug category see When preferred? When to exercise caution? Decide goals when adding agents: Stop treatment which has not had desired effect. Offer self-monitoring routinely to people on sulfonylurea, insulin and when using steroids (see Self-monitoring Pathway). Select oral agent according to quick reference guide (refer to individual drug safety information before prescribing). Individualised HbA1c Tight control Modest control Recent diagnosis Long life expectancy Low risk of hypoglycaemia On oral agents that don t cause hypoglycaemia Few vascular complications Good resources/compliance with follow up Frail elderly Long disease duration Shorter life expectancy High risk of hypoglycaemia Hypoglycaemia with optimum insulin Established vascular complications Poor resources/compliance with follow up Example: In a frail 85 year old lady with risk of fall aim for modest control. In a 50 year old lady, with no co-morbidity aim for tight control. * Please seek advice from community specialist nurses ( )/secondary care if there is diagnostic uncertainty or uncertainty about target HbA1c. Guideline 667FM of 11 Uncontrolled if printed

4 Oral treatment Choice of medication is dependent on patient parameters please see oral agents quick reference on page 5. Monotherapy: HbA1c >48 (start treatment) Aim for HbA1c of 48 (53 when on sulfonylurea) Preferred choice Alternatives Metformin Sulfonylurea* Pioglitazone SGLT-2 inhibitor DPP-4 inhibitor Dual Therapy (first intensification): HbA1c >58 on one drug Aim for HbA1c of 53 If on metformin If not on metformin Sulfonylurea* Pioglitazone SGLT-2 inhibitor DPP-4 inhibitor Sulfonylurea* + Pioglitazone Sulfonylurea* + SGLT-2 inhibitor Sulfonylurea* + DPP-4 inhibitor Pioglitazone + DPP-4 inhibitor (this combination is not licensed, under pioglitazone, but is mentioned as a treatment combination by NICE) Triple Therapy (second intensification): HbA1c >58 on two drugs Aim for HbA1c of 53 If on metformin+ sulfonylurea Other combinations Add SGLT-2 inhibitor Add pioglitazone Add DPP-4 inhibitor Consider insulin or GLP-1 after two drugs if not on metformin. Repaglinide is an alternative but has modest efficacy and compliance may be an issue as given three times a day. HbA1c is in mmol/mol. * Sulfonylureas (SUs) are cheaper than SGLT-2/DPP-4 inhibitors, however, self-monitoring is essential with SUs. Second and third choices are dependent on patient s clinical parameters. Guideline 667FM of 11 Uncontrolled if printed

5 Oral agents: Quick reference for selecting an agent Biguanide (Metformin) When preferred? First line unless contraindicated Weight neutral Probable long term cardiovascular risk reduction Safe in pregnancy Caution Renal impairment (submaximal dose <45, stop at egfr <30) Gastrointestinal side effects (use MR formulation before discontinuing) Vitamin B 12 deficiency (routine measurement not recommended) Consider using metformin modified release if gastro-intestinal symptoms experienced with standard release metformin Sulfonylurea (Gliclazide) When preferred? Early stages of diagnosis Low BMI (ensure correct type of diabetes diagnosed) Caution Hypoglycaemia avoid in frail, elderly, and if in an occupation where hypoglycaemia is risky Weight gain Thiazolinedinedione (Pioglitazone) When preferred? Caution Probable long term cardiovascular risk Heart failure, fluid retention reduction Osteoporosis at risk, or established Reduces triglyceride level Bladder cancer personal or family Can be used in renal impairment history Weight gain SGLT-2 inhibitor (First line: Dapagliflozin; Age >75: Empagliflozin; Age >85: Canagliflozin) When preferred? Caution Weight neutral - in high BMI patients may result in weight loss Euglycaemic ketosis (routine ketone testing not recommended but patient When hypoglycaemia is a concern should be warned of symptoms) Glucose independent cardiovascular Genitourinary infections (fungal, bacterial) benefit Dehydration if co-prescription with Can be used with insulin to limit weight diuretics gain and reduce insulin dose Renal impairment: May be commenced for all three therapies if egfr >60 ml/min. If already taking empagliflozin or canaglifozin they can be continued with egfr ml/min. Dapagliflozin must be discontinued if egfr <60 ml/min. DPP-4 inhibitor (Sitagliptin) When preferred? Weight neutral Early stages of diagnosis When hypoglycaemia is a concern May be used in renal failure (see dose reduction) Consider stopping in foot complications (e.g. ulcers increased risk of toe amputations) Caution High risk of pancreatitis: e.g. personal or family history, high triglycerides Needs dose reduction according to stage of renal disease (sitagliptin 25 mg/day for stages 4, 5 chronic kidney disease (CKD)) Guideline 667FM of 11 Uncontrolled if printed

6 Injectable treatment GLP-1 mimetic (See GLP-1 guidance) Consider when: Three drugs not tolerated/contraindicated/ effective or not achieving HbA1c goal on three oral drugs add GLP-1 mimetic in any of these scenarios: 1. If BMI >35 kg/m 2 (lower BMI for Asian/minority ethnic groups) 2. Obesity related physical/psychological problems at lower BMI 3. Any BMI if occupational implications to starting insulin Note: Patients may continue on metformin and/or sulfonylurea. For start/co-prescription with insulin: Community diabetes nurse referral. Agents: 1. First line liraglutide (Victoza ) 2. Alternative weekly preparation: Bydureon (Exenatide weekly) Caution: 1. High risk of pancreatitis: personal/family history, high triglycerides, alcohol abuse 2. Renal impairment: Avoid liraglutide at egfr <15 (Bydureon at egfr <50) 3. Severe hepatic impairment 4. Long disease duration: Efficacy will be reduced Insulin (See Insulin guidance) Consider when: Three drugs not tolerated/contraindicated/ effective. (For patients not on metformin may be considered after two drugs.) Insulin treatment may be necessary if HbA1c is very high/ diagnosis is uncertain/if there is hyperglycaemic emergency. Offer structured education Self-monitoring Metformin, and/or SGLT-2 inhibitors may be continued with insulin SU, DPP-4 may be used with basal insulin but unlikely to be of benefit with prandial or mixed insulin For start/co-prescription with GLP-1 mimetic: Community diabetes nurse referral Agents: (see insulin flowchart) 1. If HbA1c <75 mmol/mol, human intermediate acting insulin (e.g. NPH) OD/BD with other hypoglycaemics 2. If HbA1c >75 mmol/mol, human NPH insulin OD/BD with short acting insulin or analogue pre-mixed insulins where multiple injections may be challenging 3. Analogue pre-mixed insulin if requiring mixed insulin. Consider analogue basal insulin e.g. Lantus if hypoglycaemia on NPH or once daily administration required 4. Use basal bolus regimen in younger patients/flexible lifestyle Caution: 1. Higher risk of hypoglycaemia Guideline 667FM of 11 Uncontrolled if printed

7 Structured Education when Initiating a GLP-1 or Insulin Therapy: When starting insulin or GLP-1 therapy, use a structured programme that encompasses: structured programme of education continuing telephone support frequent self-monitoring dose titration to target dietary understanding management of hypoglycaemia management of acute changes in plasma glucose control support from an appropriately trained and experienced healthcare professional Guideline 667FM of 11 Uncontrolled if printed

8 Starting Insulin Therapy in People with Type 2 Diabetes If other measures do not keep HbA1c to <59 mmol/mol (or other agreed target), discuss benefits and risks of insulin treatment. Initiate with structured programme (as specified in Insulin Self-Management for Adults with Type 2 Diabetes 1 ) HbA1c <75 mmol/mol 2 HbA1c 75 mmol/mol 2 Begin with human NPH 3 insulin, e.g. Insulatard or Humulin I taken at bedtime or twice-daily according to need Consider basal-bolus regimen tailored to the needs of the individual, e.g. glulisine (Apidra ) + NPH Consider twice-daily analogue pre-mixed (e.g. Novomix 30). A oncedaily regimen may be an option. Alternatively, consider a once-daily long-acting insulin analogue, e.g. Lantus or biosimilar (AI) if: the person needs help with injecting insulin and a long-acting insulin analogue would reduce injections from twice to once-daily, or the person s lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes, or the person would otherwise need twice-daily basal insulin injections plus oral glucose lowering drugs, or the person cannot use any of the NPH insulin devices. Note: Sulfonylurea should be reviewed when starting insulin. Stop if patients are on short acting or pre-mixed insulin. Continue metformin and/or SGLT-2 inhibitors with insulin if tolerated. Review GLP-1 agonist when starting insulin. Insulin can be added to a GLP-1 agent and vice versa. Please see guideline 109FM. 1 Aylesbury Vale and Chiltern CCG, Insulin Self-Management for Adults with Type 2 Diabetes (service specification), September Or individually agreed target. 3 NPH = Neutral Protamine Hagedorn Guideline 667FM of 11 Uncontrolled if printed

9 References 1. NICE Type 2 diabetes in adults: management: guidance (NG28) 2. MHRA: SGLT-2 inhibitors: updated advice on the risk of diabetic ketoacidosis. Drug Safety Update, Volume 9, Issue 9, April MHRA: Canagliflozin (Invokana, Vokanamet ): signal of increased risk of lower extremity amputations in trial in high cardiovascular risk patients. Drug Safety Update, Volume 9, Issue 11, June MHRA: SGLT-2 Inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes). Drug Safety Update, Volume 10, Issue 8, March See also: Guideline 109FM Glucagon-Like Peptide-1 (GLP-1) Agonists for Adults with Type 2 Diabetes Guideline Title Management of Type 2 Diabetes: Blood-Glucose-Lowering Therapy Guideline Number 667FM Version 5.1 Effective Date January 2018 Review Date January 2021 Amended June 2018 Approvals: Diabetes Guidelines Group 9 th October 2017 Formulary Management Group 2 nd September 2015 Medicines Management 9 th November 2017 and 9 th April 2018 Subcommittee Clinical Guidelines Subgroup 10 th November 2017 and 8 th June 2018 Accountable Care System 6 th December 2017 Medicines optimisation Board Author/s Dr Chitra Ballav, Consultant, Diabetes and Endocrinology Breda Cronnolly, Medicines Optimisation & Interface Pharmacist Gill Dunn, Diabetes Specialist Nurse, Buckinghamshire CCG SDU(s)/Department(s) responsible for updating the guideline Diabetes and Endocrinology Aylesbury Vale and Chiltern CCGs Uploaded to Intranet 9 th January 2018 and 25 th June 2018 Buckinghamshire Healthcare NHS Trust/Buckinghamshire Clinical Commissioning Group Guideline 667FM of 11 Uncontrolled if printed

10 Appendix 1: Patient Information on Home Blood Glucose Testing in Type 2 Diabetes Guideline 667FM.5 10 of 11 Uncontrolled if printed

11 Guideline 667FM.5 11 of 11 Uncontrolled if printed