diabetes%20mellitus
DIABETES MELLITUS
Diabetes mellitus (DM) is a heterogenous metabolic disorder characterized by the presence of hyperglycemia with carbohydrate, protein and fat metabolism disturbance which results from defects in either insulin secretion or action.
Patients with DM usually present with polyuria, polydipsia and unexplained weight loss.
Type 1 DM is caused by beta cell destruction which leads to complete insulin deficiency. It may be immune mediated or idiopathic.
Patients may present with ketoacidosis or acute onset of hyperglycemia while other patients may resemble type 2 DM or symptoms of other autoimmune disorders.
Type 2 DM is the most common form of diabetes. It is secondary to defect in insulin secretion concomitant with insulin resistance.
Majority of patients are asymptomatic. Ketoacidosis is uncommon and is usually secondary to stress (eg infection).

Principles of Therapy

  • Overall target is to improve quality of life and prevent early death
    • Short-term: Relief of symptoms and acute complications
    • Long-term: Achieve target blood sugar level, reduce concurrent risk factors, identify and treat chronic complications
  • Diabetes mellitus is a progressive disease where pharmacologic agents are likely to become a necessity in most patients even if they are compliant to dietary and physical activity recommendations
  • Fasting hyperglycemia should be controlled and is necessary in stabilizing HbA1c in poorly controlled patients with diabetes
    • Postprandial hyperglycemia should be identified and managed in patients with suboptimal glycemic control (HbA1c 6.5-7.5%)

Therapy for Type 1 Diabetes Mellitus

  • Consists of intensive insulin therapy which administers multiple-dose Insulin injections or continuous subcutaneous insulin infusion (CS II) therapy, matching prandial insulin to carbohydrate intake, premeal glucose and expected activity, and using insulin analogue in patients with hypoglycemia

Therapy for Type 2 Diabetes Mellitus

  • Goals of pharmacological therapy include:
    • To achieve patient-individualized glucose targets
      • A1c goal of ≤6.5% is recommended
      • A1c goal may be modified to >6.5% if risk of hypoglycemia is high
    • To reduce risk of hypoglycemia
    • To facilitate weight loss in obese/overweight patients and to prevent additional gain in weight
    • To prevent appearance of cardiovascular disease and other comorbidities
  • Lifestyle modification with Metformin is recommended for newly diagnosed diabetes mellitus patients or those with mild hyperglycemia
    • Metformin may be used as background therapy and may be combined with other medications in cases when therapeutic goal is not achieved with monotherapy alone
    • Other therapeutic agents (eg Glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors, sodium-glucose linked transporter-2 inhibitors, alpha-glucosidase inhibitors and sulfonylureas) may be used in patients with intolerance to Metformin
  • Combination therapy may be started in patients with HbA1c of >7.5% according to American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) 2017 or >9% according to American Diabetes Association  2017 or those not able to reach the therapeutic goal with monotherapy alone
    • Combination therapy is Metformin plus another antidiabetic agent
    • Complementary drugs belonging to other classes should be used in patients who are intolerant of Metformin
  • Triple therapy is recommended for patients unresponsive to dual combination therapy
  • Combination insulin injectable therapy is initiated when HbA1c is >10% or if the patient has symptoms of hyperglycemia or in patients that have not achieved target A1c after 3 months of triple oral anti-DM therapy
    • When  initiating combination injectable therapy, Metformin therapy should be continued while dosages of other medications are adjusted or discontinued 
  • In individuals who are overweight and obese patients, management of obesity serves as a cornerstone for the treatment of diabetes mellitus
    • Reduction in body fat mass leads to better secretory function of Insulin
    • Effectively reduces morbidity and mortality in patients with type 2 diabetes mellitus
  • Weight loss in overweight and obese patients through lifestyle modification, medications and/or surgery is a priority in type 2 diabetes mellitus management

Guidelines in Using Oral Antidiabetic Agent in Diabetes Mellitus

  • Therapeutic goals and drug choice should be individualized in patients with comorbidities
  • Start oral antidiabetic agent at a low dose while stressing the need of diet and physical activity
  • Daily dosing of oral antidiabetic agents may improve compliance
  • In diabetes mellitus patients under stress (eg infection), insulin therapy is recommended
  • When treatment with single oral antidiabetic agent fails to achieve therapeutic goal, combination with another class of oral antidiabetic agents or basal insulin may be given

Intercurrent Illness (eg any illness, trauma, and/or surgery)

  • Stress can aggravate glycemic control and may precipitate hyperglycemic crisis
  • Frequent blood glucose monitoring is required; urine and blood ketone levels should also be checked in ketosis-prone patients
  • Temporary adjustment of treatment is needed in patients with hyperglycemic crisis
    • Provide adequate fluid and caloric intake
    • Insulin may be temporarily needed by patients on non-insulin therapy or medical nutrition therapy alone

Hypoglycemia (Plasma Glucose <70 mg/dL/3.9 mmol/L)

  • Primary limiting factor in glycemic management of type 1 and Insulin-treated type 2 diabetes mellitus
  • Should be treated with glucose (15-20 g) or any form of carbohydrate as an alternative
    • IV glucose may be administered to treat severe hypoglycemia
    • Glucagon IM should be given to patients at significant risk of severe hypoglycemia

Immunization

  • Common preventable infectious diseases such as influenza and pneumonia are associated with high mortality and morbidity in older people and in patients with chronic diseases like diabetes mellitus
  • Give influenza vaccine yearly to all patients with diabetes mellitus
  • Give pneumococcal polysaccharide vaccine (PPSV23) to all patients with diabetes mellitus aged 2-64 years old
    • In patients ≥65 years old, pneumococcal conjugate vaccine (PCV13) is given followed by a dose of PPSV23 vaccine at least a year after and at least 5 years after the last dose of PPSV23
  • Administer 3-dose series hepatitis B vaccine to unvaccinated diabetes mellitus patients aged 19-59 years old
    • Consider giving hepatitis B vaccine to unvaccinated diabetes mellitus patients >60 years old

Pharmacotherapy

Antidiabetic Agents

Alpha-glucosidase Inhibitors (eg Acarbose, Miglitol, Voglibose)

  • Indicated in treating patients with type 2 diabetes mellitus as monotherapy or as a combination therapy
    • May be used together with Insulin and have synergistic effect when given with other oral antidiabetic agents, however, hypoglycemia may occur
    • Does not cause weight gain or hypoglycemia if used as monotherapy
  • Most suitable in patients with moderately elevated glucose and HbA1c
  • Reduce digestion rate of polysaccharides in the proximal small intestine by inhibiting α-glucosidase enzymes, which is essential for the release of glucose from more complex carbohydrates
    • Delay absorption of carbohydrate which lowers postprandial blood glucose and insulin levels
  • One of the agents that primarily affects postprandial glucose
  • Lower HbA1c by 0.5-1%; less effective than Metformin or sulfonylureas
  • Must be taken during meals; may cause bloating
Biguanides (eg Metformin)
  • 1st-line treatment option for patients with type 2 diabetes mellitus due to low cost, low side effects and hypoglycemia risk, and lack of associated weight gain
  • Lower blood glucose by up to 20% through reduction in hepatic glucose production
  • Affect both fasting plasma glucose and postprandial glucose
  • May improve peripheral glucose disposal while it suppresses appetite and promotes weight reduction
  • May be used as monotherapy which will decrease HbA1c by 1.5-2% without associated hypoglycemia
  • Have synergistic effect to further lower the blood glucose level when used in combination with other agents
  • Able to increase insulin sensitivity and lower insulin requirements
  • May cause modest weight loss or weight stability, as compared to other antidiabetic agents
  • May also be given to prevent type 2 diabetes mellitus in patients with impaired glucose tolerance, impaired fasting glucose or HbA1c of 5.7-6.4%, especially if BMI <35 kg/m2, age <60 years old, and women with gestational diabetes mellitus history
  • Some studies have shown beneficial effect on cardiovascular disease outcomes (ie reduces LDL-C and triglycerides levels)
  • Periodic vitamin B12 measurement should be considered in patients who are on long-term treatment of Metformin as it is associated with biochemical vitamin B12 deficiency, especially in those patients with anemia or peripheral neuropathy 

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (eg Alogliptin, Gemigliptin, Linagliptin, Saxagliptin, Sitagliptin, Teneligliptin, Vildagliptin)

  • Indicated as monotherapy or in combination with Metformin, sulfonylurea or thiazolidinedione for patients with type 2 diabetes mellitus as an adjunct to diet and exercise
    • When used in combination with Insulin, dose of Insulin or sulfonylurea should be decreased to lower the risk of hypoglycemia
  • Decrease the rate of incretin inactivation which are usually released in the gut throughout the day and increased after meals
    • Incretins increase the release of insulin from pancreatic β-cells and decrease secretion of glucagon from pancreatic α-cells
  • Affect both fasting plasma glucose and postprandial glucose
  • Reduce HbA1c by 0.5-0.8% with improved efficacy when used at higher HbA1c baselines
  • Based on 2 large clinical trials involving patients with heart disease, it was found that Alogliptin and Saxagliptin may increase the risk of heart failure in patients with heart or kidney disease
  • Do not cause hypoglycemia or weight gain
    • May be given to patients if further gain in weight would exacerbate or cause significant problems 
  • May be taken without regard to food

Glucagon-Like Peptide-1 (GLP-1) Agonists (eg Albiglutide, Dulaglutide, Exenatide, Liraglutide, Lixisenatide)

  • Possess endogenous glucagon-like peptide-1 activity but are resistant to dipeptidyl peptidase-4 enzyme breakdown, resulting in longer action
    • Increases insulin release when glucose concentration is elevated, alters gastric emptying, prevents postprandial rise in plasma glucagon and causes satiety leading to lower caloric intake and possible weight loss
  • Reduce HbA1c by 0.9% and lowers postprandial glucose
  • May be used to treat obese patients with type 2 diabetes mellitus who are already on Metformin and/or sulfonylurea
  • May also be given as 3rd-line agent or as an alternative to adding insulin therapy in patients who failed to reach target glucose level on dual therapy with Metformin and/or sulfonylurea
    • Dose of sulfonylurea should be reduced to lower the risk of hypoglycemia when combined with glucagon-like peptide-1 agonist
  • Except for twice-daily Exenatide, all glucagon-like peptide-1 agonists are contraindicated in patients with personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2
  • Liraglutide may be a 3rd-line option to further improve blood glucose level in obese patients with type 2 diabetes mellitus who fail to reach target glucose level even with Metformin and a thiazolidinedione
    • Liraglutide should also be considered in patients with long-standing suboptimally controlled type 2 diabetes mellitus and established atherosclerotic cardiovascular disease as it has been shown to reduce cardiovascular and all-cause mortality when added to standard care
  • Exenatide immediate-release formulation must be given within 60 minutes before breakfast and dinner while Exenatide extended-release formulation can be given at any time of the day with or without meals
    • Not recommended for patients with end-stage renal disease or severe renal impairment, or with weight loss especially when used concomitantly with Metformin
  • Albiglutide and Dulaglutide are currently approved glucagon-like peptide-1 receptor agonists that are useful as add-on therapies for patients with inadequately controlled diabetes mellitus during oral monotherapy
Meglitinides/Non-Sulfonylurea Insulin Secretagogues (eg Mitiglinide, Nateglinide, Repaglinide)
  • Useful in controlling postprandial glucose
  • Short-acting insulin secretagogues that bind to a different site within the sulfonylurea receptor that stimulate secretion of insulin
  • Decrease HbA1c by 0.5%
  • Must be administered more frequently because of short half-life as compared with sulfonylureas, and fast absorption from the gastrointestinal tract; peak level at 1 hour post-administration and eliminated within 4-6 hours
  • May be used in combination with Metformin, thiazolidinediones, or alpha-glucosidase inhibitors
    • Concomitant use of Repaglinide and Gemfibrozil should be avoided due to higher risk of hypoglycemia
    • Should be taken within 10-15 minutes before main meal
  • May cause weight gain similar to sulfonylureas but has lower risk for hypoglycemia

Sodium-Glucose Linked Transporter/Co-transporter 2 (SGLT-2) Inhibitors (eg Canagliflozin, Dapagliflozin, Empagliflozin)

  • Sodium-glucose linked transporter 2 inhibitors reduce reabsorption of glucose in the renal tubules leading to increased excretion of glucose via urine
  • Indicated as monotherapy or in combination with Metformin or as a 2nd-line therapy
  • Studies have shown that Canagliflozin can significantly reduce HbA1c levels of patients with type 2 diabetes mellitus as compared to placebo
    • In the CANVAS Program, results showed that patients treated with Canagliflozin had lower rates of cardiovascular events and lower risk of hospitalization for heart failure
  • A once-daily monotherapy with Dapagliflozin or as an add-on to Metformin can significantly reduce HbA1c levels by 0.5-1%
  • Empagliflozin can be used as a monotherapy and has been found to be effective as an add-on therapy to Metformin plus a sulfonylurea, or to Pioglitazone with or without Metformin as it can reduce HbA1c by 0.5-0.6% compared to a placebo over 24 weeks
    • In the EMPA-REG clinical trial, type 2 DM patients with high risk for cardiovascular events who took Empagliflozin in addition to standard care have a lower rate of cardiovascular events, all-cause mortality and lower risk of hospitalization for heart failure (when compared to those who took placebo) 
  • Other beneficial effects of sodium-glucose linked transporter inhibitors-2 inhibitors include reduction of fasting and 2-hour postprandial glucose levels, body weight, blood pressure and increases in HDL levels
  • Found to be associated with increased risk of genitourinary infections and slightly increased LDL-C
  • Canagliflozin and Dapagliflozin was found in clinical trials to have increased incidence of bone fractures

Sulfonylureas/Insulin Secretagogues (eg 2nd generation : Glibenclamide, Gliclazide, Glimepiride, Glipizide, Gliquidone; 1st generation: Chlorpropamide, Tolazamide, Tolbutamide)

  • One of the 2nd-line options in patients intolerant of or with contraindication to Metformin
  • One of the agents that primarily affects fasting plasma glucose
  • Decrease plasma glucose up to 25% by increasing secretion of insulin
  • Reduce HbA1c by 1.5-2%
  • Dose may be increased at intervals of 1-2 weeks until satisfactory glycemic control or maximum dose is reached
  • Have similar effectiveness in controlling hyperglycemia
  • May be used in combination with other antidiabetic agents or Insulin to improve glucose control
  • Should not combine 2 different sulfonylureas
  • May increase appetite and lead to weight gain
  • Risk of hypoglycemia is higher in patients with renal impairment, liver cirrhosis and elderly
    • Glibenclamide causes the highest rate of hypoglycemia as compared to other sulfonylureas
    • Glimepiride and Gliclazide causes lower risk for hypoglycemia and weight gain
  • Must be taken 30 minutes before meals
    • Glimepiride and Gliclazide may be taken just before meals

Thiazolidinediones (eg Pioglitazone, Rosiglitazone)

  • A peroxisome proliferator-activated receptor-gamma agonist that increases insulin sensitivity of muscle, adipose tissue and liver to endogenous and exogenous insulin
  • One of the agents that primarily affects fasting plasma glucose
  • Reduce HbA1c by 0.5-1.5% when used as monotherapy
  • Elevate HDL-C, lower blood pressure, reduce inflammation markers, decrease hepatic steatosis, decrease carotid and coronary artery thickening and prevent restenosis after percutaneous transluminal coronary angioplasty
  • Glycemic control may only be improved after 6 weeks and maximal effect may be seen up to 6 months after starting therapy
  • May be given in combination with sulfonylureas, Metformin, DPP-4 inhibitors or SGLT-2 inhibitors
    • Use with insulin should be avoided, high rates of heart failure reported
  • May be given to patients with marked insensitivity to insulin 
  • May cause weight gain or fracture especially in distal upper or lower limb but may not be a reason for discontinuation
  • Not recommended for patients with congestive heart failure (CHF) due to potential fluid retention
  • Observational studies have shown concerns on cardiovascular safety of Rosiglitazone, hence Pioglitazone is preferred
    • Some meta-analyses have shown that patients treated with Rosiglitazone have higher risk for heart attack
      • However, others (eg DREAM and ADOPT trials) did not find the association between Rosiglitazone and increased major adverse cardiovascular disease events risk statistically significant
    • Rosiglitazone use is restricted to patients already treated successfully with this drug, to patients whose blood sugar does not respond to other antidiabetic agents, and to patients who, after consulting with their healthcare provider opted not to use Pioglitazone-containing products
    • In certain countries,  enrollment in the Avandia-Rosiglitazone Medicines Access Program is required before healthcare providers and patients can prescribe and receive Rosiglitazone
    • In 2015, United States Food & Drug Administration concluded that Rosiglitazone monotherapy did not show additional cardiovascular disease risks in comparison to Metformin and a sulfonylurea combination based on independent review of the RECORD trial
      • Hence, the restriction on prescribing and dispensing has been lifted

Other Antidiabetic Agents

Amylin Analogue (eg Pramlintide)

  • A synthetic analogue of human amylin that slows gastric emptying without altering overall nutrients absorption, suppresses pancreatic secretion of glucagon, and enhances satiety that leads to decrease of caloric intake
    • Shown to induce weight loss and lower insulin doses
  • Used as an adjunct treatment in patients with type 1 and 2 diabetes mellitus who use mealtime insulin, have failed to reach target glucose control despite optimal insulin therapy
    • Indicated only in patients who are willing to add 2-4 injections and more frequent glucose monitoring in their regimen
  • May be used in addition to prandial insulin therapy that may lower postprandial hyperglycemia, HbA1c and weight
    • Reduce HbA1c by 0.4% and weight by 1 kg after 6 months
  • Only other medication approved for the treatment of type 1 diabetes mellitus
  • May be used in combination with sulfonylurea and/or Metformin in type 2 diabetes mellitus
  • Causes 50% reduction in preprandial, rapid-acting or short-acting insulin dosages
  • Should be given immediately before each main meal
  • Contraindicated in patients who are noncompliant with current insulin regimen, poorly adherent to the prescribed self-monitoring of blood glucose (SMBG), patients with HbA1c >9%, recurrent severe hypoglycemia requiring assistance during the past 6 months, with hypoglycemia unawareness, confirmed diagnosis of gastroparesis and in those that require use of drugs that stimulate gastrointestinal motility or drugs that slow the intestinal absorption of nutrients

Insulin

  • Activates insulin receptors that can rapidly control hyperglycemia through increased glucose disposal, decreased hepatic glucose production and suppression of ketogenesis
  • Required in all patients with type 1 diabetes mellitus and considered in patients with type 2 diabetes mellitus when noninsulin antidiabetic agents fail to reach target blood glucose level or when patient presents with severe hyperglycemia
  • Short-term use of insulin is considered in acute illness, surgery, stress, emergencies, severe metabolic decompensation (ie diabetic ketoacidosis, hyperosmolar hyperglycemic state)
  • Insulin regimen recommended for patients with type 1 DM consists of daily injections of long-acting basal insulin (or twice-daily injections of intermediate human insulin) and injections of rapid-acting insulin analogue or short-acting human insulin before each meal 
  • Considered as initial therapy in newly diagnosed type 2 diabetes mellitus with osmotic symptoms regardless of A1c or fasting plasma glucose (FPG), A1c>10% or FPG >13 mmol/L or as part of early insulinization regimen
  • May be administered through insulin pump or insulin pen-device or syringe
  • Use of continuous subcutaneous Insulin infusion by infusion pump to deliver Insulin in a more flexible and physiologic way which can improve glucose control while decreasing hypoglycemia risk
  • Insulin can be classified based on pharmacokinetic profiles in relation to meal times:
    • Prandial insulin has a rapid or short onset of action in controlling postprandial glucose excursion thus it is given pre-meal
    • Basal insulin has intermediate or long-acting pharmacokinetic profile that covers the basal insulin requirements in between meals and night time
    • Premixed insulin incorporates both the short- and intermediate-acting insulin in one preparation thus called biphasic insulin; covers both the postprandial glucose excursion and basal insulin needs
  • In type 2 diabetes mellitus, basal insulin may be initiated, followed by basal plus or basal bolus, then prandial or premixed insulin when fasting blood glucose has reached targeted goal but HbA1c is still not achieved
  • Insulin may be combined with oral agents (Metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 inhibitors  and thiazolidinediones)
    • Combination with sulfonylureas or glinides increases hypoglycemia risk
    • Combination with thiazolidinediones may cause weight gain, edema and possible chronic heart failure
Long-acting Basal Insulins (eg Insulin degludec, Insulin detemir, Insulin glargine)
  • Treatment option of choice when starting insulin therapy
  • Should be the 1st choice in managing patients with type 2 diabetes mellitus to target fasting plasma glucose
    • An effective option in controlling fasting plasma glucose in patients with type 2 diabetes mellitus and poor glycemic control
  • Preferred over intermediate-acting neutral protamine Hagedorn (NPH) because they do not have pronounced peak, have up to 24 hours of activity, associated with less weight gain, have lower day to day variability which results in fewer symptoms and lower nocturnal hypoglycemia

Intermediate-acting Insulin (eg Neutral protamine Hagedorn (NPH) insulin)

  • Neutral protamine Hagedorn insulin may be continued if patient reached target glucose level without having hypoglycemia and unacceptable glycemic excursions
  • Preferred for gestational diabetes patients

Rapid/Short-acting Insulins [eg Regular human insulin, Rapid-acting analogues (Insulin aspart, Insulin glulisine, Insulin lispro)]

  • Short- or rapid-acting Insulin should be considered for postprandial hyperglycemia
    • Rapid-acting Insulin usually requires addition of basal insulin
  • Insulin analogues are favored if available because regular human Insulin has inconsistent absorption which causes variable peak activity (2-4 hours), unpredictable postprandial glucose, 6-8 hours duration of action and possibility of delayed hypoglycemia
    • Regular human Insulin has slow absorption and delayed onset of action that does not match normal Insulin release in response to a meal, therefore must be given at least 30 minutes before a meal

Premixed Insulins (eg 70% NPH/30% regular, 70% Insulin aspart protamine/30% Insulin aspart, 75% Insulin lispro protamine/25% Insulin lispro, 50% Insulin lispro protamine/50% Insulin lispro)

  • Offers component of both postprandial and intermediate-release glucose control
  • May lack dosage flexibility and limited to some extent in reaching blood glucose targets except if administered more frequently or in higher doses, which may increase hypoglycemia risk and weight gain
  • Analogue premixed Insulins are preferred over human premixed Insulins because of their faster onset of action, stable postprandial glucose control and lower variability in activity
Concentrated Insulin
  • U-300 Insulin glargine and U-200 Insulin degludec are 3 and 2 times more concentrated than their U-100 formulations 
    • They have longer durations of action  
    • Higher doses of basal insulin administration per volume be used
  • U-500 regular insulin is 5 times concentrated than U-100 regular insulin that has delayed onset and longer duration of action possessing both prandial and basal properties
  • There is also now available U-200 rapid-acting Insulin lispro
  • These formulations may improve compliance and comfort in patients with insulin resistance who require larger doses of Insulin
    • To minimize risk of dosing errors, prefilled pens with or without vials are available 
Inhaled Insulin
  • Available for prandial use with a more limited dosing range
  • Not advisable to use in patients with chronic lung disease, those who smoke or who recently stopped smoking
Other Preparations
  • Studies have shown that a combination of basal Insulin and glucagon-like peptide-1 receptor agonists are associated with less hypoglycemia and with weight loss but may be less tolerable and have a greater cost
    • Available preparations of combination of basal Insulin and glucagon-like peptide-1 receptor agonists are Insulin glargine plus Lixisenatide and Insulin degludec plus Liraglutide


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