Version July 2025
The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). A preliminary evaluation has not found evidence that the use of these medicines causes suicidal thoughts or actions, but the FDA is continuing to investigate this issue. Patients should not stop taking GLP-1 RAs without consulting their health care provider. Health care providers should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.
Further information may be found at https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type.
Liraglutide, one of the components of insulin degludec/liraglutide, causes dose-dependent and treatment duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether insulin degludec/liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
Insulin degludec/liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of insulin degludec/liraglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with insulin degludec/liraglutide.
Diabetes mellitus, type 2, treatment:
Note: Due to lack of additive glycemic benefit, avoid concomitant use with a dipeptidyl peptidase-4 inhibitor (Ref). Consider a dose reduction (eg, by 50%) or discontinuation of insulin secretagogues (sulfonylureas, meglitinides) to avoid hypoglycemia (Ref).
SubQ:
Initial:
Note: Discontinue therapy with basal insulin or a GLP-1 agonist prior to initiation of the combination product.
Patients naive to basal insulin or a GLP-1 agonist: 10 units (insulin degludec 10 units/liraglutide 0.36 mg) once daily.
Patients currently on basal insulin or a GLP-1 agonist: 16 units (insulin degludec 16 units/liraglutide 0.58 mg) once daily.
Dose titration: Titrate dosage upwards or downwards by 2 units (insulin degludec 2 units/liraglutide 0.072 mg) once or twice weekly (every 3 to 4 days) until the desired fasting plasma glucose is achieved. Maximum dose: 50 units (insulin degludec 50 units/liraglutide 1.8 mg)/day
Missed dose: Resume with next regularly scheduled dose; do not administer an extra dose or increase dose to account for missed dose. If more than 3 days have elapsed since last dose, reinitiate at the initial dosage once daily
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild or moderate impairment: There are no specific dosage adjustments provided in the manufacturer's labeling (limited experience); however, dosage adjustments may be necessary as insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied)
There are no dosage adjustments provided in the manufacturer's labeling (combination product has not been studied). Insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
>10%:
Endocrine & metabolic: Hypoglycemia (14% to 37%; severe hypoglycemia: <1%)
Immunologic: Antibody development (2% to 11%; antibody formation has not been associated with reduced efficacy)
1% to 10%:
Gastrointestinal: Diarrhea (8%), increased serum lipase (7%), nausea (8%)
Local: Injection site reaction (3%; mild and transitory)
Nervous system: Headache (9%)
Respiratory: Nasopharyngitis (10%), upper respiratory tract infection (6%)
Frequency not defined:
Cardiovascular: Increased heart rate
Endocrine & metabolic: Hypokalemia, weight gain
Local: Hypertrophy at injection site (lipohypertrophy), lipoatrophy at injection site, lipotrophy at injection site (lipodystrophy)
Postmarketing:
Dermatologic: Allergic skin reaction, urticaria
Endocrine & metabolic: Amyloidosis (localized cutaneous at injection site)
Gastrointestinal: Abdominal distension, abdominal pain, constipation, decreased appetite, dyspepsia, eructation, flatulence, gastritis, gastroesophageal reflux disease, vomiting
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Hypersensitivity to insulin degludec, liraglutide, or any component of the formulation; history of or family history of medullary thyroid carcinoma (MTC); patients with multiple endocrine neoplasia syndrome type 2 (MEN2); during episodes of hypoglycemia
Canadian labeling: Additional contraindications (not in US labeling): Pregnant or breastfeeding women
Concerns related to adverse effects:
• Antibody formation: Development of antibodies to insulin and liraglutide may occur. In clinical trials with insulin degludec/liraglutide combination, antibody formation was not associated with reduced efficacy. In clinical trials with liraglutide, patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1C.
• Gallbladder disease: Cholelithiasis and cholecystitis have been reported in patients treated with liraglutide, with the majority of patients requiring hospitalization or cholecystectomy; gallbladder studies and further clinical assessment are indicated if cholelithiasis is suspected.
• GI symptoms: Most common reactions are gastrointestinal related; these symptoms may be dose-related and may decrease in frequency/severity with gradual titration and continued use.
• Glycemic control: Hyper- or hypoglycemia may result from changes in insulin strength, manufacturer, type, and/or administration method. The most common adverse effect of insulin is hypoglycemia. The timing of hypoglycemia differs among various insulin formulations. Hypoglycemia may result from changes in meal pattern (eg, macronutrient content, timing of meals), changes in the level of physical activity, increased work or exercise without eating, or changes to coadministered medications. Use of long-acting insulin preparations (eg, insulin degludec, insulin detemir, insulin glargine) may delay recovery from hypoglycemia. Patients with renal or hepatic impairment may be at a higher risk. Symptoms differ in patients and may change over time in the same patient; awareness may be less pronounced in those with long-standing diabetes, diabetic nerve disease, patients taking beta-blockers, or in those who experience recurrent hypoglycemia. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death. Insulin requirements may be altered during illness, emotional disturbances, or other stressors. Instruct patients to use caution with ethanol; may increase risk of hypoglycemia.
• Hypersensitivity: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with liraglutide and with insulin degludec; discontinue use if hypersensitivity reactions occur and treat promptly as indicated. It is not known if patients with a history of hypersensitivity to other GLP-1 agonists are at increased risk for hypersensitivity reactions with liraglutide; patients with prior serious reactions to similar agents should be monitored closely.
• Hypokalemia: Insulin (especially IV insulin) causes a shift of potassium from the extracellular space to the intracellular space, possibly producing hypokalemia. If left untreated, hypokalemia may result in respiratory paralysis, ventricular arrhythmia and even death. Use with caution in patients at risk for hypokalemia (eg, loop diuretic use). Monitor serum potassium and supplement potassium when necessary.
• Pancreatitis: Cases of acute and chronic pancreatitis (including fatal and nonfatal, hemorrhagic or necrotizing pancreatitis) have been reported with GLP-1 receptor agonists; monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain which may radiate to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue use. Do not resume unless an alternative etiology of pancreatitis is confirmed. It is not known if liraglutide increases risk for development of pancreatitis in patients with a history of pancreatitis.
• Renal effects: Acute renal failure and chronic renal failure exacerbation (including severe cases requiring hemodialysis) have been reported with liraglutide; some cases have been reported in patients with no known preexisting renal disease. Reports primarily occurred in patients with nausea, vomiting, diarrhea, or dehydration. Renal dysfunction was usually reversible with appropriate corrective measures, including discontinuation of liraglutide. Risk may be increased in patients receiving concomitant medications affecting renal function and/or hydration status.
• Thyroid tumors: [US Boxed Warning] Dose-dependent and treatment duration-dependent thyroid C-cell tumors have developed in animal studies with liraglutide therapy; it is unknown whether liraglutide will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Patients should be counseled on the potential risk of MTC with the use of liraglutide and informed of symptoms of thyroid tumors (eg, neck mass, dysphagia, dyspnea, persistent hoarseness). Use is contraindicated in patients with a personal or a family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN2). Patients who develop elevated calcitonin concentrations or have thyroid nodules detected during imaging studies or physical exam should be further evaluated. Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with liraglutide.
Disease-related concerns:
• Bariatric surgery:
– Presurgical assessment of the indication for use, symptoms, and goals of therapy should be documented to enable postsurgical assessment. Insulin therapy is the preferred treatment for diabetes in the early postoperative period. However, due to wide interpatient variability, close monitoring and dosage adjustments are required to maintain target blood glucose levels and avoid hypoglycemia (AACE/ASMBS/OMA/ASA [Mechanick 2020b]). Studies found prior to discharge persons with type 1 diabetes required an average insulin dose reduction of 31% to 50% and patients with type 2 diabetes required a 61% to 87% dose reduction (Cruijsen 2014; Diemer 2017; Kassel 2021; Middelbeek 2014; Vilarrasa 2017; Wirunsawanya 2021). Furthermore, one year following surgery, 60% of persons with type 2 diabetes were in remission and able to discontinue insulin therapy (Ardestani 2015; Arterburn 2013; Buchwald 2009; Schauer 2003; Varban 2022).
– Dipeptidyl peptidase 4 inhibitors, glucagon-like peptide-1 agonists, insulin, and metformin are preferred for outpatient glucose management following bariatric surgery (AACE/ASMBS/OMA/ASA [Mechanick 2020b]). Consider alternatives to insulin for glucose management in type 2 diabetes due to the risk of hypoglycemia and weight gain associate with long-term insulin therapy (Apovian 2015; AACE/ASMBS/OMA/ASA [Mechanick 2020b]). Monitor and adjust the insulin dose for hypoglycemia, hyperglycemia, or weight gain in persons requiring insulin, including persons with type 1 diabetes.
– Bariatric surgery increases endogenous postprandial glucagon-like peptide 1 (GLP1) (Meek 2016). However, several studies suggest the post-surgery use of exogenous GLP1 agonists does not increase the risk of adverse effects due to excessive GLP1 exposure (Jensen 2023; Miras 2019; Mok 2023; Samuels 2024). Yet, retrospective cohort studies suggest liraglutide users had a higher incidence of intraabdominal adhesions leading to more technically complex surgeries (Hakim 2022; Martines 2024). Monitor for continued efficacy and tolerability post surgery and consider switching to an alternate medication if condition worsens.
• Cardiac disease: Concurrent use with peroxisome proliferator-activated receptor (PPAR)-gamma agonists, including thiazolidinediones (TZDs) may cause dose-related fluid retention and lead to or exacerbate heart failure, particularly when used in combination with insulin. If PPAR-gamma agonists are prescribed, monitor for signs and symptoms of heart failure. If heart failure develops, consider PPAR-gamma agonist dosage reduction or therapy discontinuation.
• Gastroparesis: Liraglutide slows gastric emptying; has not been studied in patients with preexisting gastroparesis.
• Hepatic impairment: Use with caution in patients with hepatic impairment, insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely. Dosage adjustments may be necessary.
• Renal impairment: Use with caution in patients with renal impairment. Dosage adjustments may be necessary.
Dosage form specific issues:
• Multiple dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).
Other warnings/precautions:
• Appropriate use: Not approved for use in patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.
• Surgical and endoscopic procedures: Use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) has been associated with elevated residual gastric contents, which may increase the risk for adverse events during anesthesia and deep sedation (including aspiration) (Kobori 2023; Marroquin-Harris 2023; Silveira 2023). In some studies, delayed gastric emptying induced by GLP-1 RAs returned to baseline after 8 to 12 weeks of continuous therapy; therefore, risk may be higher in patients who recently initiated therapy or who use GLP-1 RAs intermittently (Raven 2024; van Zuylen 2024). Although the American Society of Anesthesiologists has suggested holding GLP-1 RAs prior to planned procedures requiring general anesthesia, the risks and benefits of this approach have not been evaluated (AGA [Hashash 2024]; ASA [Joshi 2023]). For example, in patients using GLP-1 RAs for glycemic control, holding the medication may result in perioperative hyperglycemia and increase the risk of adverse postoperative outcomes (AGA [Hashash 2024]; van Zuylen 2024). Individualize the decision to hold the GLP-1 RA based on patient-specific factors such as the indication (eg, glycemic control vs weight management), duration and frequency of therapy, presence of adverse GI symptoms, and concomitant medications that may slow gastric emptying (eg, opioids, proton pump inhibitors); may consider additional preoperative interventions (eg, clear liquid diet, full stomach precautions, gastric ultrasound) on a case-by-case basis to reduce risk (ASA [Hashash 2024]; Marroquin-Harris 2023; Raven 2024; van Zuylen 2024). Refer also to institutional protocols.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Xultophy: 100/3.6: Insulin degludec 100 units and liraglutide 3.6 mg per mL (3 mL) [contains phenol]
No
Solution Pen-injector (Xultophy Subcutaneous)
100-3.6 unit-mg/mL (per mL): $107.28
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Xultophy: 100/3.6: Insulin degludec 100 units and liraglutide 3.6 mg per mL (3 mL) [contains phenol]
SubQ: For SubQ use only. Do not administer IM, IV, or via an insulin pump. Cold injections should be avoided. Inject into the abdomen, thigh, or upper arm. Rotate injection sites for each dose; do not use the same site for each injection to avoid lipodystrophy or localized cutaneous amyloidosis. Rotating from an injection site where lipodystrophy/cutaneous amyloidosis is present to an unaffected site may increase risk of hypoglycemia. Administer once daily at the same time each day with or without food. Do not split the dose. Solution should appear clear and colorless; do not use if particulate matter or coloration is seen. Do not mix or dilute with any other insulin or solution. Prefilled pen dials in 1-unit increments. For the prefilled pen, prime the needle before each injection by turning the dose selector to the priming symbol and injecting into the air (use a new needle for each injection). Once injected, continue to depress the button until the dial has returned to 0 and for an additional 6 seconds. Then, remove the needle.
Liraglutide was removed from the NIOSH list of hazardous drugs in healthcare settings with the 2024 update (NIOSH 2024).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Xultophy: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf#page=42
Diabetes mellitus, type 2, treatment: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (insulins, all formulations and strengths, SUQ, IV) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care and Long-Term Care Settings). Due to the number of insulin preparations, it is essential to identify/clarify the type of insulin to be used.
Cross-contamination may occur if insulin pens are shared among multiple patients. Steps should be taken to prohibit sharing of insulin pens.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Alectinib: Glucagon-Like Peptide-1 Agonists may decrease serum concentration of Alectinib. Risk C: Monitor
Alpha-Glucosidase Inhibitors: May increase hypoglycemic effects of Insulin. Management: Consider a decrease in insulin dose when initiating therapy with an alpha-glucosidase inhibitor and monitor patients for hypoglycemia. Risk D: Consider Therapy Modification
Alpha-Lipoic Acid: May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Androgens: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May increase adverse/toxic effects of Antidiabetic Agents. Specifically, beta-blockers may mask the hypoglycemic symptoms of antidiabetic agents. Risk C: Monitor
Beta-Blockers (Nonselective): May increase hypoglycemic effects of Insulin. Beta-Blockers (Nonselective) may decrease therapeutic effects of Insulin. Risk C: Monitor
Bortezomib: May increase therapeutic effects of Antidiabetic Agents. Bortezomib may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Chlorprothixene: May increase hypoglycemic effects of Insulin. Risk C: Monitor
Clarithromycin: May increase hypoglycemic effects of Insulin. Risk C: Monitor
Dipeptidyl Peptidase-IV Inhibitors: May increase hypoglycemic effects of Insulin. Management: Consider a decrease in insulin dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider Therapy Modification
Direct Acting Antiviral Agents (HCV): May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Edetate CALCIUM Disodium: May increase hypoglycemic effects of Insulin. Risk C: Monitor
Etilefrine: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Glucagon-Like Peptide-1 Agonists: Liraglutide may increase adverse/toxic effects of Glucagon-Like Peptide-1 Agonists. Risk X: Avoid
Guanethidine: May increase hypoglycemic effects of Antidiabetic Agents. Risk C: Monitor
Herbal Products with Glucose Lowering Effects: May increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Hyperglycemia-Associated Agents: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Hypoglycemia-Associated Agents: May increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Macimorelin: Coadministration of Insulin and Macimorelin may alter diagnostic results. Risk X: Avoid
Maitake: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Meglitinides: Glucagon-Like Peptide-1 Agonists may increase hypoglycemic effects of Meglitinides. Management: Consider meglitinide dose reductions when used in combination with glucagon-like peptide-1 agonists, particularly when also used with basal insulin. Risk D: Consider Therapy Modification
Metreleptin: May increase hypoglycemic effects of Insulin. Management: Insulin dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely for signs and symptoms of hypoglycemia. Risk D: Consider Therapy Modification
Monoamine Oxidase Inhibitors: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Pegvisomant: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Pioglitazone: May increase adverse/toxic effects of Insulin. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. Management: If insulin is combined with pioglitazone, consider insulin dose reductions to avoid hypoglycemia. Monitor patients for fluid retention and signs/symptoms of heart failure, and consider pioglitazone dose reduction or discontinuation if heart failure occurs Risk D: Consider Therapy Modification
Pramlintide: May increase hypoglycemic effects of Insulin. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Risk D: Consider Therapy Modification
Propranolol: Liraglutide may decrease therapeutic effects of Propranolol. Specifically, the heart rate lowering effect of propranolol may be diminished. Propranolol may increase hypoglycemic effects of Liraglutide. Propranolol may decrease therapeutic effects of Liraglutide. Risk C: Monitor
Prothionamide: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Quinolones: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Quinolones may decrease therapeutic effects of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor
Reproterol: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Ritodrine: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Rosiglitazone: Insulin may increase adverse/toxic effects of Rosiglitazone. Specifically, the risk of fluid retention, heart failure, and hypoglycemia may be increased with this combination. Risk X: Avoid
Salicylates: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Selective Serotonin Reuptake Inhibitor: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Semaglutide: May increase adverse/toxic effects of Glucagon-Like Peptide-1 Agonists. Risk X: Avoid
Sincalide: Drugs that Affect Gallbladder Function may decrease therapeutic effects of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider Therapy Modification
Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors: May increase hypoglycemic effects of Insulin. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Risk D: Consider Therapy Modification
Sulfonylureas: Glucagon-Like Peptide-1 Agonists may increase hypoglycemic effects of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Risk D: Consider Therapy Modification
Thiazide and Thiazide-Like Diuretics: May decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Tirzepatide: May increase adverse/toxic effects of Glucagon-Like Peptide-1 Agonists. Risk X: Avoid
Adverse events were observed in some animal reproduction studies. Refer to individual monographs for additional information.
Both exogenous and endogenous insulin are present in breast milk (study not conducted with this preparation) (Whitmore 2012).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Refer to individual monographs for additional information.
Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy
Plasma glucose (individualize frequency based on treatment regimen, hypoglycemia risk, and other patient-specific factors) (ADA 2023); electrolytes; renal function; hepatic function; weight; signs/symptoms of pancreatitis; triglycerides; signs/symptoms of gallbladder disease.
Gestational diabetes mellitus: Blood glucose 4 times daily (1 fasting and 3 postprandial) until well controlled, then as appropriate (ACOG 2018).
HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2023; KDIGO 2020).
Recommendations for glycemic control in patients with diabetes:
Nonpregnant adults (AACE [Samson 2023]; ADA 2023):
HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.
Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).
Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).
Older adults (≥65 years of age) (ADA 2023):
Note: May consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (ES [LeRoith 2019]).
HbA1c: <7% to 7.5% (healthy); <8% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.
Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).
Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).
Pregnant patients:
HbA1c: Pregestational diabetes (type 1 or type 2) (ADA 2023):
Preconception (patients planning for pregnancy): <6.5%.
During pregnancy <6% (if can be achieved without significant hypoglycemia) or <7% if needed to prevent hypoglycemia.
Capillary blood glucose: Note: Less stringent targets may be appropriate if goals cannot be achieved without causing significant hypoglycemia (ADA 2023).
Gestational diabetes mellitus (ACOG 2018; ADA 2023):
Fasting: <95 mg/dL (SI: <5.3 mmol/L).
Postprandial: <140 mg/dL (SI: <7.8 mmol/L) (at 1 hour) or <120 mg/dL (SI: <6.7 mmol/L) (at 2 hours).
Pregestational diabetes mellitus (type 1 or type 2) (ADA 2023 ):
Fasting: 70 to 95 mg/dL (SI: 3.9 to 5.3 mmol/L).
Postprandial: 110 to 140 mg/dL (SI: 6.1 to 7.8 mmol/L) (at 1 hour) or 100 to 120 mg/dL (SI: 5.6 to 6.7 mmol/L) (at 2 hours).
Perioperative care in adult patients with diabetes (ADA 2023): Target glucose range during perioperative period: Consider targeting 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L).
Recommendations for hospitalized adult patients with hyperglycemia:
Noncritically ill adult patients: Target glucose range: 140 to 180 mg/dL (SI: 7.8 to 10 mmol/L); <140 mg/dL (SI: <7.8 mmol/L) may be appropriate for selected patients, if it can be achieved without excessive hypoglycemia (ADA 2023).
Classification of hypoglycemia (ADA 2023):
Level 1: 54 to 70 mg/dL (SI: 3 to 3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.
Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.
Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.
Refer to individual agents.
Refer to individual agents.
