Skip to Content
Visit ConferenceInsider for CEU-EBR 2017 diabetes topics | Read More

Insulin Glargine

Pronunciation

(IN soo lin GLAR jeen)

Index Terms

  • Glargine Insulin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Lantus: 100 units/mL (10 mL) [contains metacresol]

Solution Pen-injector, Subcutaneous:

Basaglar KwikPen: 100 units/mL (3 mL) [contains metacresol]

Lantus SoloStar: 100 units/mL (3 mL) [contains metacresol]

Toujeo SoloStar: 300 units/mL (1.5 mL) [contains metacresol]

Brand Names: U.S.

  • Basaglar KwikPen
  • Lantus
  • Lantus SoloStar
  • Toujeo SoloStar

Pharmacologic Category

  • Insulin, Long-Acting

Pharmacology

Insulin acts via specific membrane-bound receptors on target tissues to regulate metabolism of carbohydrate, protein, and fats. Target organs for insulin include the liver, skeletal muscle, and adipose tissue.

Within the liver, insulin stimulates hepatic glycogen synthesis. Insulin promotes hepatic synthesis of fatty acids, which are released into the circulation as lipoproteins. Skeletal muscle effects of insulin include increased protein synthesis and increased glycogen synthesis. Within adipose tissue, insulin stimulates the processing of circulating lipoproteins to provide free fatty acids, facilitating triglyceride synthesis and storage by adipocytes; also directly inhibits the hydrolysis of triglycerides. In addition, insulin stimulates the cellular uptake of amino acids and increases cellular permeability to several ions, including potassium, magnesium, and phosphate. By activating sodium-potassium ATPases, insulin promotes the intracellular movement of potassium.

Normally secreted by the pancreas, insulin products are manufactured for pharmacologic use through recombinant DNA technology using either E. coli or Saccharomyces cerevisiae. Insulin glargine differs from human insulin by adding two arginines to the C-terminus of the B-chain in addition to containing glycine at position A21 in comparison to the asparagine found in human insulin. Insulins are categorized based on the onset, peak, and duration of effect (eg, rapid-, short-, intermediate-, and long-acting insulin). Insulin glargine is a long-acting insulin analog.

Absorption

Slow; upon injection into the subcutaneous tissue, microprecipitates form which allow small amounts of insulin glargine to release over time

Metabolism

Partially metabolized in the subcutaneous depot at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin)

Excretion

Urine

Onset of Action

Basaglar: Peak effect: No pronounced peak

Lantus: 3 to 4 hours; Peak effect: No pronounced peak

Toujeo: 6 hours

Time to Peak

Plasma: Lantus: No pronounced peak; Basaglar: ~12 hours

Duration of Action

Lantus, Basaglar: Generally 24 hours or longer; reported range (Lantus): 10.8 to >24 hours (up to ~30 hours documented in some studies) (Heinemann 2000)

Special Populations: Renal Function Impairment

Insulin Cl may be reduced in patients with impaired renal function.

Use: Labeled Indications

Diabetes mellitus, types 1 and 2: To improve glycemic control in adults with type 1 diabetes mellitus (insulin dependent, IDDM) and type 2 diabetes mellitus (noninsulin, NIDDM); to improve glycemic control in children ≥6 years with type 1 diabetes mellitus (Lantus and Basaglar only)

Limitations of use: Not recommended for the treatment of diabetic ketoacidosis.

Contraindications

Hypersensitivity to insulin glargine or any component of the formulation; during episodes of hypoglycemia

Documentation of allergenic cross-reactivity for insulin is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Note: Insulin glargine is a long-acting insulin administered by SubQ injection. Insulin glargine is approximately equipotent to human insulin, but has a slower onset, no pronounced peak, and a longer duration of activity. Insulin requirements vary dramatically between patients and dictates frequent monitoring and close medical supervision.

Diabetes mellitus, type 1: SubQ:

Insulin glargine-specific dosing: Initial dose: Approximately one-third to one-half of the total daily insulin requirement administered once daily. A rapid-acting or short-acting insulin should also be used to complete the balance (~1/2 to 2/3) of the total daily insulin requirement. Adjust dosage according to patient response.

Conversion to insulin glargine from other insulin therapies:

Converting from once-daily NPH insulin to insulin glargine: May be substituted on an equivalent unit-per-unit basis

Converting from twice-daily NPH insulin to insulin glargine: Initial dose: Use 80% of the total daily dose of NPH (eg, 20% reduction); administer once daily; adjust dosage according to patient response

Conversion between Toujeo, Lantus, and Basaglar:

Conversion from once-daily Toujeo to once-daily Lantus or once-daily Basaglar: Initial dose: Use 80% of the dose of Toujeo (eg, 20% reduction); adjust dosage according to patient blood glucose response.

Conversion from once-daily Lantus to once-daily Toujeo or once-daily Basaglar: Initial dose: May be substituted on an equivalent unit-per-unit basis; however, generally a higher daily dosage of Toujeo will be required to achieve the same level of glycemic control as with Lantus.

General insulin dosing (off-label):

Type 1: SubQ: Note: Multiple daily doses are utilized and guided by blood glucose monitoring. Combinations of insulin formulations are commonly used. The daily doses presented below are expressed as the total units/kg/day of all insulin formulations used. Insulin glargine must be used in combination with a rapid- or short-acting insulin.

Initial total insulin dose: 0.2 to 0.6 units/kg/day in divided doses. Conservative initial doses of 0.2 to 0.4 units/kg/day are often recommended to avoid the potential for hypoglycemia. A rapid-acting insulin may be the only insulin formulation used initially.

Usual maintenance range: 0.5 to 1 units/kg/day in divided doses. An estimate of anticipated needs may be based on body weight and/or activity factors as follows:

Nonobese: 0.4 to 0.6 units/kg/day

Obese: 0.8 to 1.2 units/kg/day

Division of daily insulin requirement ("conventional therapy"): Generally, 50% to 75% of the total daily dose (TDD) is given as an intermediate-acting or a long-acting form of insulin (eg, insulin glargine) (in 1 to 2 daily injections). The remaining portion of the TDD is then divided and administered before or at mealtimes (depending on the formulation) as a rapid-acting (eg, lispro, aspart, glulisine) or short-acting (regular) form of insulin.

Division of daily insulin requirement ("intensive therapy"): Basal insulin delivery with 1 or 2 doses of intermediate-acting or long-acting insulin formulations superimposed with doses of short-acting (regular) insulin or rapid-acting insulin (eg, lispro, aspart, glulisine) formulations 3 or more times daily.

Dosage adjustment: Dosage must be titrated to achieve glucose control and avoid hypoglycemia. Adjust dose to maintain premeal and bedtime glucose in target range. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component.

Diabetes mellitus, type 2: SubQ:

Insulin glargine-specific dosing:

Manufacturer’s labeling: Initial basal insulin dose: 0.2 units/kg once daily; for Lantus or Basaglar, up to 10 units/day initially is recommended. Adjust dosage according to patient response

Conversion to insulin glargine from other insulin therapies:

Converting from once-daily NPH insulin to insulin glargine: May be substituted on an equivalent unit-per-unit basis

Converting from twice-daily NPH insulin to insulin glargine: Initial dose: Use 80% of the total daily dose of NPH (eg, 20% reduction); administer once daily; adjust dosage according to patient response

Conversion between Toujeo, Lantus, or Basaglar:

Conversion from once-daily Toujeo to once-daily Lantus or once-daily Basaglar: Initial dose: Use 80% of the dose of Toujeo (eg, 20% reduction); adjust dosage according to patient blood glucose response.

Conversion from once-daily Lantus to once-daily Toujeo or once-daily Basaglar: Initial dose: May be substituted on an equivalent unit-per-unit basis; however, generally a higher daily dosage of Toujeo will be required to achieve the same level of glycemic control as with Lantus

Alternate recommendations (off-label):

Initial: 10 units or 0.1 to 0.2 units/kg once daily, usually in combination with metformin +/- other noninsulin agent (ADA 2017f). Alternatively, if HbA1c >8% prior to initiation of basal insulin, 0.2 to 0.3 units/kg once daily is recommended (Garber [AACE/ACE 2016]).

Dosage adjustment:

To reach fasting blood glucose target: Adjust dose by 10% to 15% or 2 to 4 units; may adjust at weekly or twice weekly intervals (ADA 2017f)

For hypoglycemia: If no clear reason for hypoglycemia, decrease dose by 4 units or by 10% to 20% (ADA 2017f)

Surgical patients: On the morning of surgery or procedure, give 60% to 80% of the usual dose of long-acting analogs (eg, detemir, glargine, or degludec) or pump “basal” insulin (rapid-or short-acting insulins) (ADA 2017d)

General considerations for insulin use in type 2 diabetes (off-label):

Timing of initiation: Dual therapy (metformin + a second antihyperglycemic agent) and then triple therapy (metformin + two antihyperglycemic agents) is recommended in patients who fail to achieve glycemic goals after ~3 months with lifestyle intervention and metformin monotherapy or dual therapy, respectively (unless contraindications to metformin exist). Preference is not given for which agent(s) should be added to metformin (drug choice should be individualized based on patient characteristics). If HbA1c target not achieved after ~3 months of triple therapy, consider initiating basal insulin (usually with metformin +/- other noninsulin agent) or if patient already receiving an optimally titrated basal insulin (ie, a long-acting insulin such as glargine, degludec, or detemir) as part of their regimen, consider combination injectable therapy (ADA 2017f).

Combination injectable therapy: If HbA1c target has not been met with basal insulin (ie, long-acting insulin such as glargine, degludec or detemir) (usually combined with metformin +/- other noninsulin agent), despite titrating basal insulin to provide acceptable fasting blood glucose concentrations, combination injectable therapy should be considered. Options include: adding a rapid-acting insulin (eg, lispro, aspart, glulisine) prior to largest meal or adding a GLP-1 receptor agonist or changing from basal insulin to a twice daily premixed insulin. If HbA1c still not adequately controlled, consider advancing from one rapid-acting insulin prior to largest meal to ‘basal-bolus’ regimen (ie, rapid-acting insulin administered before ≥2 meals) or consider advancing from a twice daily premixed insulin to a 3 times daily premixed insulin (ADA 2017f).

Patients with elevated HbA1C at therapy initiation: If HbA1c is ≥9% at initiation of therapy, dual therapy (metformin + a second antihyperglycemic agent) should be considered. If HbA1c ≥10%, blood glucose is ≥300 mg/dL or if patient is symptomatic (eg, polyuria, polydipsia), insulin therapy (with or without additional agents) should be considered (ADA 2017f).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Insulin glargine is a long-acting insulin administered by SubQ injection. Insulin glargine is approximately equipotent to human insulin, but has a slower onset, no pronounced peak, and a longer duration of activity. Changing the basal insulin component from another insulin to insulin glargine can be done on a unit-to-unit basis. Insulin requirements vary dramatically between patients and dictates frequent monitoring and close medical supervision. See Insulin Regular for additional information.

Insulin glargine-specific dosing:

Type 1 diabetes mellitus: Children ≥6 years and Adolescents: SubQ: Initial dose: Approximately one-third of the total daily insulin requirement; a rapid-acting or short-acting insulin should also be used.

Type 1 or type 2 diabetes; previously receiving basal insulin plus bolus insulin (eg, NPH + regular insulin):

Children <6 years: SubQ: Limited data available: 40% of the established total daily insulin requirement; this resulted in a reduction in hypoglycemic episodes in 35 nonobese preschool-aged children (age range: 2.6-6.3 years) when used in conjunction with a rapid-acting insulin prior to meals (Alemzadeh, 2005).

Children ≥6 years: SubQ:

Converting from once-daily NPH insulin: May be substituted on an equivalent unit-per-unit basis

Converting from twice-daily NPH insulin: Initial dose: Use 80% of the total daily dose of NPH (eg, 20% reduction); administer once daily; adjust dosage according to patient response

General insulin dosing (off-label):

Type 1 diabetes mellitus: Children and Adolescents: Note: Multiple daily doses are utilized and guided by blood glucose monitoring. Combinations of insulin formulations are commonly used. The daily doses presented below are expressed as the total units/kg/day of all insulin formulations used. Insulin glargine must be used in combination with a short-acting insulin.

Usual maintenance range: SubQ: 0.5-1 unit/kg/day in divided doses. An estimate of anticipated needs may be based on body weight and/or activity factors as follows:

Nonobese: 0.4 to 0.6 units/kg/day

Obese: 0.8 to 1.2 units/kg/day

Pubescent Children and Adolescents: During puberty, requirements may substantially increase to >1 unit/kg/day and in some cases up to 2 units/kg/day (IDF/ISPAD, 2011)

Dosage adjustment: Dosage must be titrated to achieve glucose control and avoid hypoglycemia. Adjust dose to maintain premeal and bedtime glucose in target range. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Obesity

Refer to indication-specific dosing for obesity-related information (may not be available for all indications).

Administration

SubQ administration: Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Insulin glargine should be administered once daily, at any time of day; however, administer at the same time each day. Cold injections should be avoided. SubQ administration is usually made into the thighs, arms, buttocks, or abdomen; rotate injection sites within the same region to avoid lipodystrophy. Do not dilute or mix insulin glargine with any other insulin formulation or solution. Insulin glargine prefilled pens are available in concentrations of 100 units/mL and 300 units/mL. Prefilled pens are calibrated to display the actual insulin units administered (no dosage conversion needed) and will administer up to 80 units per injection. Do not use a syringe to withdraw concentrated insulin glargine (300 units/mL) from a prefilled pen for administration. Cartridges [Canadian product] are to be used only with re-usable pens recommended by the manufacturer (refer to product labeling).

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage

Basaglar:

Prefilled pens: Store unopened prefilled pens at room temperature <30°C (86°F) for 28 days, or refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date. Once in use, store prefilled pens at room temperature <30°C (86°F) and use within 28 days; do not refrigerate. Do not freeze or use if previously frozen; protect from heat and light.

Cartridges [Canadian product]: Store unopened cartridges refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date. Once in use, store cartridges at room temperature <30°C (86°F) and use within 28 days; do not refrigerate. Do not freeze or use if previously frozen; protect from heat and light.

Lantus: Store unopened vials and prefilled pens refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date, or at room temperature <30°C (<86°F) for 28 days; do not freeze; protect from heat and sunlight. Once punctured (in use), store vials refrigerated or at room temperature <30°C (<86°F) and use within 28 days. Store prefilled pens (SoloStar) that have been punctured (in use) at temperatures <30°C (<86°F) and use within 28 days; do not freeze or refrigerate.

Toujeo: Store unopened prefilled pen (SoloStar) at 2°C to 8°C (36°F to 46°F) until expiration date; do not freeze. Store prefilled pens (SoloStar) that have been opened (in use) at <30°C (<86°F) and use within 42 days; do not freeze or refrigerate.

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Beta-Blockers: May enhance the hypoglycemic effect of Insulins. Exceptions: Levobunolol; Metipranolol. Monitor therapy

Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Consider therapy modification

Edetate CALCIUM Disodium: May enhance the hypoglycemic effect of Insulins. Monitor therapy

Edetate Disodium: May enhance the hypoglycemic effect of Insulins. Monitor therapy

Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Insulins. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Exceptions: Liraglutide. Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Liraglutide: May enhance the hypoglycemic effect of Insulins. Management: If liraglutide is used for the treatment of diabetes (Victoza), consider insulin dose reductions. The combination of liraglutide and insulin should be avoided if liraglutide is used exclusively for weight loss (Saxenda). Consider therapy modification

Metreleptin: May enhance the hypoglycemic effect of Insulins. Management: Insulin dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pioglitazone: May enhance the adverse/toxic effect of Insulins. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. Management: If insulin is combined with pioglitazone, dose reductions should be considered to reduce the risk of hypoglycemia. Monitor patients for fluid retention and signs/symptoms of heart failure. Consider therapy modification

Pramlintide: May enhance the hypoglycemic effect of Insulins. 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. Consider therapy modification

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Rosiglitazone: Insulins may enhance the adverse/toxic effect of Rosiglitazone. Specifically, the risk of fluid retention, heart failure, and hypoglycemia may be increased with this combination. Avoid combination

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

Primarily symptoms of hypoglycemia.

>10%

Cardiovascular: Hypertension (20%), peripheral edema (20%)

Central nervous system: Depression (11%)

Endocrine & metabolic: Hypoglycemia (Type I on combination regimens: ≤69%; Type II on combination regimens: ≤8%; monotherapy in adults ≥50 years old: 6% [ORIGIN trial])

Gastrointestinal: Diarrhea (11%)

Genitourinary: Urinary tract infection (11%)

Immunologic: Antibody development (20% to 44%; effect on therapy not reported)

Infection: Influenza (19%), infection (9% to 14%)

Neuromuscular & skeletal: Arthralgia (14%), back pain (13%), limb pain (13%)

Ophthalmic: Cataract (18%), retinopathy (14%)

Respiratory: Upper respiratory tract infection (adults: 6% to 29%; children & adolescents: 14%), sinusitis (19%), bronchitis (15%), nasopharyngitis (7% to 13%), cough (12%)

1% to 10%:

Cardiovascular: Retinal vascular disease (6%)

Central nervous system: Headache (6% to 10%)

Local: Pain at injection site (3%)

Respiratory: Pharyngitis (children & adolescents: 8%), rhinitis (children & adolescents: 5%)

Miscellaneous: Accidental injury (6%)

Frequency not defined:

Endocrine & metabolic: Sodium retention

Local: Erythema at injection site, itching at injection site, localized edema, swelling at injection site

<1% (Limited to important or life-threatening): Hyperglycemia, hypersensitivity reaction, hypertrophy at injection site, injection site reaction (including urticaria and inflammation), lipoatrophy at injection site, lipotrophy at injection site, skin rash, weight gain

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Severe, life-threatening allergic reactions, including anaphylaxis, may occur. If hypersensitivity reactions occur, discontinue therapy.

• Hypoglycemia: The most common adverse effect of insulin is hypoglycemia. The timing of hypoglycemia differs among various insulin formulations. Hypoglycemia may result from increased work or exercise without eating; use of long-acting insulin preparations (eg, insulin detemir, insulin glargine, insulin degludec) may delay recovery from 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.

• 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.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment. Dosage requirements may be reduced.

• Renal impairment: Use with caution in patients with renal impairment. Dosage requirements may be reduced.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Hospitalized patients with diabetes: Exclusive use of a sliding scale insulin regimen (insulin regular) in the inpatient hospital setting is strongly discouraged. In the critical care setting, continuous IV insulin infusion (insulin regular) has been shown to best achieve glycemic targets. In noncritically ill patients with either poor oral intake or taking nothing by mouth, basal insulin or basal plus bolus is preferred. In noncritically ill patients with adequate nutritional intake, a combination of basal insulin, nutritional, and correction components is preferred. An effective insulin regimen will achieve the goal glucose range without the risk of severe hypoglycemia. A blood glucose value <70 mg/dL should prompt a treatment regimen review and change, if necessary, to prevent further hypoglycemia.

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:

• Administration: Insulin glargine is a clear solution, but it is NOT intended for IV or IM administration or via an insulin pump.

• Appropriate use: Diabetes mellitus: The general objective of exogenous insulin therapy is to approximate the physiologic pattern of insulin secretion which is characterized by two distinct phases. Phase 1 insulin secretion suppresses hepatic glucose production and phase 2 insulin secretion occurs in response to carbohydrate ingestion; therefore, exogenous insulin therapy may consist of basal insulin (eg, intermediate- or long-acting insulin), insulin administered via continuous subcutaneous insulin infusion [CSII]) and/or preprandial insulin (eg, short- or rapid-acting insulin) (see Related Information: Insulin Products). Patients with type 1 diabetes do not produce endogenous insulin; therefore, these patients require both basal and preprandial insulin administration. Patients with type 2 diabetes retain some beta-cell function in the early stages of their disease; however, as the disease progresses, phase 1 insulin secretion may become completely impaired and phase 2 insulin secretion becomes delayed and/or inadequate in response to meals. Therefore, patients with type 2 diabetes may be treated with oral antidiabetic agents, basal insulin, and/or preprandial insulin depending on the stage of disease and current glycemic control. Since treatment regimens often consist of multiple agents, dosage adjustments must address the specific phase of insulin release that is primarily contributing to the patient’s impaired glycemic control. Treatment and monitoring regimens must be individualized.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Monitoring Parameters

Diabetes mellitus: Plasma glucose, electrolytes, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), potassium (in patients at risk for hypokalemia); renal function; hepatic function; weight

Pregnancy Considerations

In animal reproduction studies, outcomes were similar to those observed with regular insulin. In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008; Lambert 2013). Prior to pregnancy, effective contraception should be used until glycemic control is achieved (ADA 2017c; Kitzmiller 2008).

Insulin therapy is the preferred treatment of type 1 and type 2 diabetes in pregnant women, as well as GDM when pharmacologic therapy is needed (ADA 2017c). Insulin requirements tend to fall during the first trimester of pregnancy and increase in the later trimesters, peaking at 28 to 32 weeks of gestation. Following delivery, insulin requirements decrease rapidly (ACOG 2005).

Insulin therapy is the preferred treatment of type 1 and type 2 diabetes in pregnant women, as well as GDM when pharmacologic therapy is needed (ADA 2017c). Because insulin glargine has an increased affinity to the insulin-like growth factor (IGF-I) receptor, there are theoretical concerns that it may contribute to adverse events when used during pregnancy (Jovanovic 2007; Lambert 2013), although this has not been observed in available studies (Lambert 2013; Lepercq 2012; Pollex 2011). Women who are stable on insulin glargine prior to conception may continue it during pregnancy. Theoretical concerns of insulin glargine should be discussed prior to conception (Blumer 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation. Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), vision changes, chills, severe dizziness, passing out, seizures, shortness of breath, excessive weight gain, swelling of arms or legs, or change in skin to thick or thin at injection site (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Hide