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Comprehensive lifestyle changes [Non-Text] الجمهوريه المصريه لبنان السعوديه Saudi Society of Family and Community Medicine Drug therapy for Diabetes Mellitus: Clinical Practice Guidelines [Non-Text] Council of Cooperative Health Insurance Initial presentation with T2DM BOX1 - Patient has severe hyperglycemia:( symptoms of severe hyperglycemia ( polyuria,polydipsia, weight loss, ketosis) • Is blood glucose levels >300 mg/dL or A1C >10% at initial presentation NO Initiate Metformin in combination with life style If metformin is contraindicated or not tolerated, consider a drug from another class Yes - Consider insulin - As glucose toxicity resolves consider shifting to oral treatment - Consider combination therapy if HbA1C is 1.5% above target. HbA1c target achieved after 3 months Box2 Review twice a year NO - Does the patients have established CVD, CKD or HF ? OR - Is the patient at high risk of CVD (age >55 years with coronary or peripheral vascular disease, left ventricular hypertrophy) Yes An SGLT-2 inhibitor or GLP-1RA with demonstrated CVD benefit is recommended independent of A1C and in consideration of patient-specific factors Table 1 NO Adding a second agent to metformin is based on avoidance of side effects mainly (hypoglycemia and weight gain), cost, and patient preferences Tabel1 HbA1c target achieved after 3 months NO Review twice a year - Stepwise addition of 3rd medication to achieve A1C at target is based on the patients have established ASCVD, CKD or HF and avoidance of side effects(hypoglycemia, weight gain), cost, patient preferences. - Treatment regimens need to be continuously reviewed for efficacy, side effects, and patient response. • Discontinue agents in non responders after 6 months of use. Table 1 HbA1c target achieved after 3 months Review twice a year NO Consider GLP-1RA UNLESS Table 1 - Already on GLP-1RA or GLP-1RA not appropriate OR • insulin preferred by patient OR • HbA1c target NOT achieved after 3 months of GLP-1RA use Add basal insulin or bedtime NPH insulin INITIATION: 10 IU a day or 0.1-0.2IU/kg a day TITRATION: 2-4 units every 3 days to reach target FPG For Hypoglycemia determine cause and if not clear then lower dose by 10-20%. HbA1c target not achieved despite adequate titration of insulin OR basal dose > 0.5IU/kg OR FPG at target If on basal insulin Add prandial insulin with the largest meal INITIATION: 4IU or 10% of basal dose TITRATION: increase by 1-2 IU twice weekly If on NPH convert to twice daily 80% of current bedtime dose give 2/3 before breakfast and 1/3 before dinner For Hypoglycemia determine cause and if not clear then lower dose by 10-20%. If HbA1c target not met consider: - Stepwise additional injections of prandial insulin, two then three injections - Split insulin regimen - Premix insulin regimen Table 1 Reference : ADA- Standards Of Medical Care Diabetes Care 2021 Jan; 44(Supplement 1): S1-S2. الله بمره الجمعيه السعوديه لطب الاshire واجتماعات Saudi Society of Family and Community Medicine العربيه السعوديه Council of Cooperative Health Insurance الله بمره Table 1 : drug- specific and patients factors to consider when selecting antihyperglycemic treatment <table><tr><td rowspan="2"></td><td rowspan="2">Efficacy</td><td rowspan="2">Hypoglycemia</td><td rowspan="2">weight</td><td colspan="2">CV effect</td><td colspan="2">Renal Effect</td><td rowspan="2">Side effects & precautions</td></tr><tr><td>ASCVD</td><td>HF</td><td>CKD progression</td><td>Dosing adjustment</td></tr><tr><td>Metformin</td><td>High</td><td>No</td><td>Loss</td><td>Possible Benefit</td><td>Neutral</td><td>Neutral</td><td>review dose if CrCl <45 stop if CrCl drops below 30</td><td>nausea, anorexia, GI upset, transient diarrhea, taste disturbance, lactic acidosis, potential for B12 deficiency. suspended prior to tests requiring intravenous iodine- containing contrast and elective surgery , restart 48 hours after procedure providing renal function returned to base line</td></tr><tr><td colspan="6">Dose: start 500mg with breakfast titrate over weeks up to 2g daily in divided doses</td><td colspan="3">Ramadan: advice 2/3 of daily dose with Iftar and 1/3 with Suhur</td></tr><tr><td>SGLT-2 inhibitor Empagliflozin Canagliflozin Dapagliflozin Ertuglifozin</td><td>Intermediate</td><td>No</td><td>Loss</td><td>Benefit: Empagliflozin canagliflozin</td><td>Benefit</td><td>Benefit</td><td>Required renal dose adjustment for all SGLT-2 inhibitors</td><td>volume depletion(gastrointestinal infections, use of diuretics, age of above 75, avoid in liver impairment. Risk of DKA. Increase LDL, risk of Fournier's gangrene & long bone fracture FDA black Box-Risk of amputation with canagliflozin.</td></tr><tr><td>GLP-1 RA Exenetide Liraglutide Dulaglutide Semaglutide (weekly) semaglutide (oral)</td><td>High</td><td>No</td><td>Loss</td><td>Benefit Liraglutide Dulaglutide Semaglutide</td><td>Neutral</td><td>Benefit Liraglutide Dulaglutide Semaglutide</td><td>Required :Exenetide</td><td>gastrointestinal (discomfort, and dry mouth, burping, constipation, diarrhea, nausea, altered taste, toothache and gall bladder disorder, decreased appetite), headaches, dizziness, skin reactions, increased risk of infections, Avoid in severe impairment. FDA black Box-Risk of thyroid C-cell tumor with Liraglutide, dulaglutide, exenatide extended release</td></tr><tr><td>DPP-4 inhibitor Linagliptin Sitagliptin Vidagliptin Saxagliptin</td><td>Intermediate</td><td>No</td><td>Neutral</td><td>Neutral</td><td>Risk saxagliptin</td><td>Neutral</td><td>Required for all except linagliptin</td><td>uremia , nasopharyngitis ,cough, increased serum lipase ,urticaria, GI disturbances, peripheral edema, URI, dry mouth, headache, rash Risk of pancreatitis</td></tr><tr><td>TZD Pioglitazone</td><td>High</td><td>No</td><td>Gain</td><td>Benefit: pioglitazone</td><td>Risk</td><td>Neutral</td><td>Not required, generally not recommended in renal impairment as potential risk of fluid overload.</td><td>anemia, headache, vertigo, sweating ,visual disturbances, impotence, fatigue, insomnia, caution: increase risk of fractures , bladder cancer ,undiagnosed hematuria Benefit in NASH. FDA black Box-Risk of heart failure.</td></tr><tr><td>Sulfonylurea Gliclazide Glibenclamide Glimepride Glipazide</td><td>High</td><td>Yes</td><td>Gain</td><td>Neutral</td><td>Neutral</td><td>Neutral</td><td>Glipizide and Glimepiride initiate conservatively to avoid hypoglycaemia</td><td>usually well tolerated ,nausea ,vomiting , diarrhea, constipation, hypersensitivity reactions.</td></tr><tr><td>Insulin</td><td>Highest</td><td>Yes</td><td>gain</td><td>Neutral</td><td>Neutral</td><td>Neutral</td><td>Required</td><td>Injection site reactions</td></tr><tr><td rowspan="2">Basal Insulin</td><td>Glargine Galprine follow-on Detemir Degludec</td><td colspan="7">initiate 10 IU a day OR 0.1-0.2IU/kg a day . Titrate by increase 2 unites ( 4 units if FPG >180 mg /dl) every 3 days to reach FPG target without hypoglycemia OR dose >0.5 IU/KG On initiation of basal insulin : metformin : continue SU: option to continue, reduce or stop TZD: stop GLP-1RA continue DPP4 continue ( stop if combined injections) SGLT2 continue</td></tr><tr><td>NPH</td><td colspan="7">initiate 10 IU a day OR 0.1-0.2IU/kg a day at night . Titrate by increase 2 unites every 3 days to reach FPG target without hypoglycemia. For Twice daily regimen : Total dose 80% of current bedtime dose give 2/3 am and 1/3 bedtime</td></tr><tr><td rowspan="2">Prandial insulin</td><td>Short acting</td><td>Human regular</td><td colspan="7">Short acting(give 30-45 minutes before meal). Initiate 4 IU (or 10% of basal dose) with the largest meal . Titrate by increasing dose by 1-2 IU twice weekly</td></tr><tr><td>Rapid acting</td><td>Aspart lispro Glulisine</td><td colspan="7">Rapid acting (give immediately to 15 mins before meal). Initiate 4 IU (or 10% of basal dose) with the largest meal . Titrate by increasing dose by 1-2 IU twiceweekly.</td></tr><tr><td>Premixed insulin</td><td>Lispro 50/50 Lispro 75/25 Aspart 70/30 NPH70/30</td><td colspan="8">give immediately before meal. initial total insulin dose: 0.1-0.3 units/kg/day . Usual maintenance range: 0.5-1 units/kg/day in divided doses. Existing basal(unit-to-unit conversion) Existing basal-bolus (reduce TDD by 20-30%) Titrate 1-2 units, 1-2xweekly, until goal</td></tr></table> Combination of medications can be prescribed based on evidence and patient preferences