Insulin degludec is a biosynthetic (rDNA origin), long-acting basal human insulin analog.1
Insulin degludec is used to improve glycemic control in the management of type 1 or type 2 diabetes mellitus in adult and pediatric patients ≥1 year of age who require a long-acting insulin.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 Insulin degludec also is commercially available in fixed combination with liraglutide (Xultophy®); the fixed combination is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.36, 38, 39, 40
Insulin degludec is not indicated for the treatment of diabetic ketoacidosis; a short-acting insulin (e.g., insulin human) is the preferred agent.1, 48 Insulin degludec and liraglutide in fixed combination should not be used for the treatment of diabetic ketoacidosis or for the treatment of type 1 diabetes mellitus.36 The fixed combination also should not be used with any other preparation containing liraglutide or another GLP-1 receptor agonist.36 Data are lacking on the use of the fixed combination of insulin degludec and liraglutide with prandial insulin.36
Insulin degludec appears to be at least as effective for glycemic control as insulin glargine or insulin detemir (as determined by glycosylated hemoglobin [hemoglobin A1c ; HbA1c]) in adult and pediatric (1 year and older) patients with type 1 or type 2 diabetes mellitus and is more effective in adults with type 2 diabetes mellitus than the oral antidiabetic agent, sitagliptin.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 Current evidence suggests that the prolonged duration of action and low variability in insulin degludec concentrations over the dosing interval may contribute to potentially lower rates of hypoglycemia (particularly nocturnal hypoglycemia) compared with other basal insulins.1, 2, 3, 5, 9, 12, 14, 18, 19, 21 The peakless pharmacokinetic profile of insulin degludec allows for the timing of a once-daily injection to be varied from day to day in adults (when required) without increasing the risk of hypoglycemia; this flexibility in dosing may make insulin therapy less demanding and more acceptable to some patients, potentially improving patient compliance and glycemic control.1, 12, 14, 19, 21, 25 Some clinicians suggest that insulin degludec may be a more suitable option than other basal insulins (i.e., insulin detemir, insulin glargine) in individuals who are prone to hypoglycemia and in those who require twice-daily administration of a basal insulin for adequate glycemic control,15 as well as in patients who experience variability in glycemic control with other basal insulins.16, 21
Safety and efficacy of insulin degludec for the treatment of type 1 diabetes mellitus has been demonstrated in comparisons with insulin detemir or insulin glargine in 3 randomized, open-label, noninferiority phase 3 trials of 26 or 52 weeks' duration in adults and a study in pediatric patients 1-17 years of a patients also received mealtime insulin aspart during these trials.1, 2, 3, 4, 35 In a phase 3 trial in adults with type 1 diabetes mellitus who had been treated with basal and rapid-acting (“bolus”) insulins for at least 1 year, patients received insulin degludec once daily with the evening meal or insulin glargine once daily at the same time each day, both in conjunction with mealtime insulin aspart.1, 2 Basal insulin dosages were titrated based upon fasting plasma glucose concentrations.2 After 52 weeks of therapy, the decrease in HbA1c from baseline was similar between treatment groups (average reduction in HbA1c of 0.36 and 0.34% for insulin degludec and insulin glargine, respectively).1 The rate of nocturnal hypoglycemia (per patient-year of exposure) with insulin degludec in this trial was 25% lower than that with insulin glargine; however, the rate of severe hypoglycemic episodes did not differ substantially between the treatment groups.2 In a similar phase 3 trial, adults with type 1 diabetes mellitus received insulin degludec or insulin detemir once daily between the evening meal and bedtime, both in conjunction with mealtime insulin aspart.1, 3 Patients who received insulin detemir were eligible to receive a second dose daily if there was inadequate glycemic control after at least 8 weeks of therapy.3 Basal insulin dosages were titrated based upon fasting blood glucose concentrations.3 After 26 weeks of therapy, the decrease in HbA1c from baseline was similar between treatment groups (average reduction in HbA1c of 0.71 and 0.61% for insulin degludec and insulin detemir treatment groups, respectively).1 Treatment with insulin degludec was associated with a substantially lower rate of nocturnal hypoglycemia than insulin detemir.3 In a third phase 3 trial, adults with type 1 diabetes mellitus received insulin degludec once daily (at the same time each day or at alternating times daily [minimum of 8 and maximum of 40 hours between doses]) or insulin glargine once daily, all in conjunction with mealtime insulin aspart.1, 4 Basal insulin dosages were titrated based upon fasting plasma glucose concentrations.4 After 26 weeks of therapy, the treatment group that received insulin degludec at varying times of the day had similar reductions in HbA1c as those patients who received insulin degludec or insulin glargine injections at the same time every day (average reduction in HbA1c of 0.41, 0.4, and 0.57% for insulin degludec administered at the same time each day, insulin degludec administered at varying times, and insulin glargine treatment groups, respectively).1 The treatment group receiving insulin degludec at varying times of the day had lower rates of nocturnal hypoglycemia than the insulin glargine treatment group.4
In another study, pediatric patients 1-17 years of age (mean age: 10 years) with type 1 diabetes mellitus received insulin degludec once daily or insulin detemir once or twice daily, all in conjunction with mealtime insulin aspart.1, 35 After 26 weeks of therapy, the mean decrease in HbA1c from baseline did not differ substantially between treatment groups (reduction in HbA1c of 0.19 and 0.34% for insulin degludec and insulin detemir treatment groups, respectively).1 At the conclusion of the additional 26-week extension period of this study, the observed mean decrease in HbA1c remained similar between the 2 treatment groups; no substantial difference in the rates of hypoglycemia between groups was observed.35
Safety and efficacy of insulin degludec administered once daily in adults with type 2 diabetes mellitus have been established in 6 open-label, randomized clinical trials of 26 or 52 weeks' duration that compared insulin degludec with sitagliptin or with other basal insulins (i.e., insulin detemir or insulin glargine) in conjunction with oral antidiabetic agents or mealtime insulin.1, 5, 6, 7, 8, 9, 10 In a noninferiority trial in insulin-naïve patients with type 2 diabetes mellitus who were inadequately controlled with oral antidiabetic therapy, once-daily therapy with insulin degludec or insulin glargine was added to existing therapy with metformin with or without a dipeptidyl peptidase-4 (DPP-4) inhibitor.1, 5 Insulin degludec and insulin glargine provided similar improvements in glycemic control (as measured by HbA1c, the primary clinical end point) in this trial.1, 5 The proportion of patients attaining target HbA1c values of less than 7% at trial end point was similar across treatment groups.1, 5 The risk of nocturnal hypoglycemia was lower with insulin degludec compared with that observed with insulin glargine.5
In another noninferiority trial in insulin-naïve Asian patients with type 2 diabetes mellitus who were inadequately controlled with oral antidiabetic therapy, once-daily therapy with insulin degludec or insulin glargine was added to existing therapy with 1 or more oral antidiabetic agents (metformin, a sulfonylurea, a meglitinide, or an alpha-glucosidase inhibitor).1, 7 Patients receiving a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide or liraglutide) or a thiazolidinedione within 3 months of trial screening were excluded from the trial.1, 7 All patients received an initial insulin degludec or insulin glargine dosage of 10 units subcutaneously once daily.1, 7 Insulin dosages were titrated once weekly based on fasting plasma glucose concentrations.7 After 26 weeks of treatment, the observed mean HbA1c and fasting plasma glucose concentrations were similar for insulin degludec and insulin glargine.1, 7 Additionally, there was no substantial difference in the proportion of patients achieving an HbA1c less than 7%.1, 7
In a trial evaluating the safety and efficacy of varying the daily injection time of insulin degludec, adults with type 2 diabetes mellitus inadequately controlled on basal insulin, oral antidiabetic agents, or a combination of these agents received insulin degludec once daily with the evening meal, insulin degludec once daily at varying times, or insulin glargine once daily.1, 8 Patients who received insulin degludec at varying times were given alternating morning and evening injections (minimum of 8 hours and maximum of 40 hours maintained between injections).8 Patients receiving once-daily basal insulin prior to the study were transitioned to insulin degludec or insulin glargine on a unit-for-unit basis.8 Insulin dosages were titrated individually once a week throughout the trial based upon fasting plasma glucose concentrations.8 Patients receiving oral antidiabetic agents were allowed to continue treatment with up to 3 oral antidiabetic agents (metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione) during the trial.1 Overall, insulin degludec given at variable dosing intervals resulted in similar glycemic control, hypoglycemic risk, and weight gain compared with either insulin glargine or insulin degludec given at fixed dosing intervals.8 There was no substantial difference in HbA1c between patients who received insulin degludec once daily, insulin degludec once daily at varying administration times, or insulin glargine once daily.1, 8
In a noninferiority trial in adults with type 2 diabetes mellitus inadequately controlled on insulin and/or oral antidiabetic agents, no difference in overall glycemic control (as assessed by HbA1c) was observed in patients receiving therapy with insulin degludec or insulin glargine;1, 9 however, insulin degludec therapy was associated with a lower risk of hypoglycemia than insulin glargine.9 In this trial, patients received once-daily insulin degludec or once-daily insulin glargine, both in combination with mealtime insulin aspart, with or without oral antidiabetic agents (metformin, pioglitazone, or both).1, 9 After 52 weeks of treatment, HbA1c decreased by 1.1 and 1.2% in the insulin degludec and insulin glargine treatment groups, respectively.1, 9 Rates of overall, nocturnal, and diurnal hypoglycemia were substantially lower in patients treated with insulin degludec versus insulin glargine.9
In a trial comparing the efficacy of insulin degludec with sitagliptin in insulin-naïve adults with type 2 diabetes mellitus, insulin degludec improved glycemic control and was superior to sitagliptin in terms of lowering HbA1c.1, 10 Patients in this trial received add-on treatment with subcutaneous insulin degludec once daily at any time of the day (minimum of 8 hours and maximum of 40 hours between injections) or sitagliptin 100 mg orally once daily; all patients were receiving stable therapy with 1-2 oral antidiabetic agents (metformin, a meglitinide, a sulfonylurea, or pioglitazone) at baseline.1, 10 The starting dosage of insulin degludec was 10 units once daily, which was titrated weekly based upon fasting plasma glucose concentrations.10 Sitagliptin was administered at a dosage of 100 mg orally once daily.10 After 26 weeks of treatment, HbA1c was reduced by 1.52 and 1.09% in patients receiving insulin degludec and sitagliptin therapy, respectively.1, 10 Patients receiving insulin degludec therapy also had a lower fasting blood glucose after 26 weeks of treatment compared with those receiving sitagliptin therapy (mean fasting glucose 112 versus 154 mg/dL, respectively).1, 10
Insulin Degludec/Liraglutide Fixed-combination Therapy
Safety and efficacy of insulin degludec and liraglutide in fixed combination for the treatment of type 2 diabetes mellitus have been established in 6 parallel, randomized, active- or placebo-controlled phase 3 clinical trials of 26 weeks' duration in adults with type 2 diabetes mellitus.36, 37, 38, 39, 40
In 3 clinical studies, the use of the fixed combination of insulin degludec and liraglutide substantially improved glycemic control in adults with type 2 diabetes mellitus who had inadequate glycemic control with oral antidiabetic agents and who were naïve to therapy with a basal insulin or GLP-1 receptor agonist.36 In the first study, all patients continued on prestudy treatment with metformin with or without pioglitazone.36 In addition to the prestudy treatment, patients also received insulin degludec and liraglutide in fixed combination (initially 10 units of insulin degludec and 0.36 mg liraglutide), liraglutide (initially 0.6 mg), or insulin degludec (initially 10 units) subcutaneously once daily.36 Patients in the fixed-combination group or the insulin degludec treatment group had their dosages titrated twice weekly towards a target fasting plasma glucose concentration of 72-90 mg/dL.36 Patients in the liraglutide treatment group followed a fixed-escalation scheme with weekly dosage increases of 0.6 mg until the maintenance dosage of 1.8 mg once daily was achieved.36 After 26 weeks, the reduction in HbA1c from baseline was 1.81, 1.35, or 1.21% in patients treated with the fixed combination of insulin degludec and liraglutide, insulin degludec, or liraglutide, respectively.36 In the second study, all patients continued on prestudy treatment with a sulfonylurea with or without metformin.36 In addition to the prestudy treatment, patients also received insulin degludec and liraglutide in fixed combination (initially 10 units of insulin degludec and 0.36 mg liraglutide) or placebo once daily.36 Patients in the fixed-combination group had their dosage titrated twice weekly towards a target fasting plasma glucose concentration of 72-108 mg/dL.36 After 26 weeks, the reduction in HbA1c from baseline was 1.42 or 0.62% in patients treated with the fixed combination of insulin degludec and liraglutide or placebo, respectively.36 In the third study, the fixed combination of insulin degludec and liraglutide was compared to insulin glargine as add-on therapy in patients with inadequate glycemic control on a sodium-glucose cotransporter 2 (SGLT2) inhibitor alone or in combination with other oral antidiabetic agents (with or without metformin, pioglitazone, and/or DPP-4 inhibitor).36, 42 All patients continued on prestudy treatment with the exception of the DPP-4 inhibitor, which was discontinued at randomization.36, 42 In addition to prestudy treatment, patients also received the fixed combination of insulin degludec and liraglutide (initially 10 units of insulin degludec and 0.36 mg liraglutide) or insulin glargine (initially 10 units) subcutaneously once daily; dosages were titrated twice weekly (by no more than 4 units) towards a fasting plasma glucose concentration of 72—90 mg/dL.36, 42 After 26 weeks, the reduction in HbA1c from baseline was 1.97% or 1.59% in patients treated with the fixed combination of insulin degludec and liraglutide or insulin glargine, respectively.36
In another trial, insulin-naïve adults with type 2 diabetes mellitus who were inadequately controlled on metformin alone or in combination with pioglitazone and/or a sulfonylurea plus maximum-dose (or maximally tolerated) liraglutide (mean daily dosage at baseline: 1.7 mg) continued to receive their pretrial therapy or had their therapy converted from liraglutide to the fixed combination of insulin degludec and liraglutide.36, 38 Oral antidiabetic agents were continued at pretrial dosages throughout the trial in both treatment groups.36 The starting dosage of the fixed combination was insulin degludec 16 units and liraglutide 0.58 mg once daily; dosage adjustments were performed twice weekly based on fasting blood glucose concentrations (end-of-trial dosage of the fixed combination: insulin degludec 44 units and liraglutide 1.58 mg daily).36, 38 After 26 weeks, the reduction in HbA1c from baseline was 1.31 or 0.36% with the fixed combination of insulin degludec and liraglutide versus liraglutide, respectively.36, 38 A mean weight gain from baseline of 2 kg was observed in patients receiving the fixed combination of insulin degludec and liraglutide compared with a weight loss of 0.8 kg in those receiving liraglutide.38 A higher rate of hypoglycemia was observed in the fixed-combination treatment group.38
In another trial comparing the fixed combination of insulin degludec and liraglutide with insulin degludec therapy in adults with type 2 diabetes mellitus who were inadequately controlled with basal insulin and metformin with or without a sulfonylurea or a meglitinide, patients who received the fixed combination at equivalent insulin dosages achieved superior glycemic control.36, 39 In this trial, all basal insulins and oral antidiabetic drugs except for metformin hydrochloride (mean daily dosage: 1984 mg) were discontinued at randomization; patients received a starting insulin degludec dosage of 16 units (given separately or in fixed combination with liraglutide 0.58 mg) once daily, which was titrated biweekly based on fasting plasma glucose concentrations.39 After 26 weeks, the mean daily dosage of insulin degludec was 46 units (with liraglutide 1.66 mg in the fixed combination) in both treatment groups.36 The reductions in HbA1c from baseline were superior with the fixed combination of insulin degludec and liraglutide compared with insulin degludec treatment (reduction of 1.94 versus 1.05%, respectively).36 There was no substantial difference between the 2 treatment groups with regard to hypoglycemia.39
In another trial comparing the fixed combination of insulin degludec and liraglutide with insulin glargine therapy in adults with type 2 diabetes mellitus inadequately controlled on insulin glargine and metformin, patients who received the fixed combination of insulin degludec and liraglutide achieved substantially greater reductions in HbA1c compared with those who received insulin glargine.36, 40 Patients in this trial either continued treatment with insulin glargine or were switched to the fixed combination of insulin degludec and liraglutide, both in conjunction with metformin.36, 40 The starting insulin degludec dosage was 16 units daily (with liraglutide 0.58 mg in the fixed combination), irrespective of the patient's previous daily dosage of insulin glargine (mean insulin glargine pretrial dosage: 31 units daily).40 Patients whose therapy was switched from insulin glargine to the fixed combination of insulin degludec and liraglutide showed no worsening of blood glucose control immediately following the switch, despite the initial reduction in insulin dosage for patients who received the fixed combination.40 Each treatment was titrated biweekly based on fasting blood glucose concentrations with no upper dosing limit in the insulin glargine group and a maximum daily dosage of 50 units of insulin degludec in the fixed-combination treatment group.40 The mean dosage of the fixed combination of insulin degludec and liraglutide or insulin glargine was 41 units insulin degludec and 1.48 mg liraglutide or 66 units of insulin glargine daily, respectively.36 The reductions in HbA1c from baseline were substantially greater with the fixed combination of insulin degludec and liraglutide compared with insulin glargine (reduction of 1.67 versus 1.16%, respectively).36
The American Diabetes Association (ADA) publishes an annual guideline on diabetes management, which provides clinical practice recommendations for glucose-lowering therapies in patients with diabetes mellitus.43 The current 2025 ADA guideline states that in adults with type 2 diabetes mellitus, pharmacologic strategies that provide sufficient effectiveness to achieve and maintain the intended treatment goals should be used and guided by a person-centered shared decision-making approach.43 In general, higher-efficacy approaches have a greater likelihood of achieving glycemic control.43 Weight management should be included as a distinct treatment goal, and other healthy lifestyle behaviors should also be considered.43 When selecting an appropriate treatment regimen, clinicians should be guided by factors such as cardiovascular and renal comorbidities, drug efficacy and adverse effects, hypoglycemic risk, presence of overweight or obesity, cost, access, and patient preferences.43 For the treatment of type 2 diabetes mellitus, insulin should be considered in patients with symptoms of hyperglycemia or when the HbA1cor blood glucose are very high (i.e., HbA1c >10% or blood glucose ≥300 mg/dL).43 Insulin therapy, typically starting with basal insulin, may also be considered in patients on other antidiabetic agents who require additional glycemic control.43 When insulin is used for the treatment of type 2 diabetes mellitus, combination therapy with a glucagon-like peptide-1 (GLP-1) receptor agonist should be considered for greater glycemic control and for the beneficial effect on weight and hypoglycemia risk.43 For the treatment of type 1 diabetes mellitus, treatment with insulin is essential and should be tailored to the individual patient to meet glycemic goals, prevent diabetic ketoacidosis, and minimize the risk of hypoglycemia.43 Typical insulin treatment plans for patients with type 1 diabetes mellitus include a combination of basal, mealtime, and correction insulin.43 In all patients with diabetes mellitus treated with insulin, routine assessment of administration technique is essential to ensure optimized safety and efficacy.43
The American Association of Clinical Endocrinology (AACE) also publishes guidelines for the management of diabetes mellitus.44, 45 The principles of diabetes management outlined in these guidelines are similar to those recommended by the ADA.44, 45 For patients with type 2 diabetes mellitus, insulin may be used to achieve glycemic control after failure of other antidiabetic agents or in those patients with catabolic symptoms (e.g., weight loss) or high HbA1c or blood glucose values (i.e., HbA1c >10% or blood glucose ≥300 mg/dL).44 Insulin therapy (starting with basal insulin alone or in combination with a GLP-1 receptor agonist) may also be considered in patients on other antidiabetic agents (including a GLP-1 receptor agonist) who require additional glycemic control.44 Insulin is recommended for the treatment of all patients with type 1 diabetes mellitus.45
Dispensing and Administration Precautions
Insulin degludec is administered by subcutaneous injection once daily.1 Because of its delayed absorption and long duration of action, insulin degludec may be administered at any time of the day in adults.1, 20 However, in pediatric patients, the drug should be administered once daily at the same time every day.1
The fixed combination of insulin degludec and liraglutide (Xultophy®) is administered by subcutaneous injection once daily at the same time each day without regard to meals in adults; the injection is commercially available for administration in a prefilled, single-patient-use injection pen.36 The accompanying labeling should be consulted for proper methods of administration and care of the injection pen36
Insulin degludec or the fixed combination of insulin degludec and liraglutide should not be given IV or IM, nor should it be given via an insulin infusion pump.1, 36 Insulin degludec or the fixed combination with liraglutide should not be mixed with any other insulin preparations or solutions.1, 36
Insulin degludec or the fixed combination of insulin degludec and liraglutide is administered subcutaneously into the thigh, abdomen, or upper arm.1, 36 A planned rotation of sites within an area should be followed to reduce the risk of lipodystrophy and localized cutaneous amyloidosis; injections should not be placed into areas of existing lipodystrophy or localized cutaneous amyloidosis.1, 36
Insulin degludec (Tresiba®) is commercially available for administration in the FlexTouch®prefilled, single-patient-use injection pen; the drug is also available in a multiple-dose vial.1 The accompanying labeling should be consulted for proper methods of administration and care of the FlexTouch® pen or the multiple-dose vial.1 Insulin degludec should not be transferred from the FlexTouch® injection pen into a syringe for administration.1 Dose conversions between the insulin degludec 100- and 200-units/mL FlexTouch® injection pens based on the differences in insulin concentration are not necessary and should not be performed.1, 6 The dose window for the insulin degludec 100- and 200-units/mL FlexTouch® injection pens display the number of insulin degludec units to be delivered independent of insulin concentration, and no conversion is needed to calculate the dose using either injection pen.1, 6 Insulin degludec may alternatively be administered by subcutaneous injection from the multiple-dose vial using a syringe and needle.1
For adults who miss a dose of insulin degludec, the missed dose should be administered as soon as remembered during waking hours if at least 8 hours have elapsed between consecutive doses.1 If a pediatric patient misses a dose of insulin degludec, the patient or a parent or caregiver should be instructed to contact the child's clinician for guidance about dosing and monitoring blood glucose concentrations more frequently until the next scheduled insulin degludec dose.1 Patients who miss a dose of the fixed combination of insulin degludec and liraglutide should be instructed to resume the once-daily regimen as prescribed with the next scheduled dose; however, if more than 3 days have elapsed since the last dose, the fixed combination therapy should be re-initiated at the starting dose to mitigate GI symptoms related to the liraglutide component. 1
Unopened injection pens and multiple dose vials containing insulin degludec should be stored at 2-8°C until the expiration date.1 Alternatively, unopened insulin degludec injection pens and vials may be stored at room temperature (up to 30°C) for up to 56 days.1 Injection pens containing insulin degludec and vials containing insulin degludec should not be subjected to freezing; if freezing has occurred, the pen/vial should not be used.1 Vials containing insulin degludec should be stored in the original sealed carton to protect from light.1 In-use insulin degludec pens and vials may be stored at room temperature (up to 30°C) or under refrigeration (2-8°C) away from direct heat and light for up to 56 days.1
Unopened injection pens containing the fixed combination of insulin degludec and liraglutide should be stored at 2-8°C until the expiration date.36 Injection pens containing the fixed combination preparation should not be subjected to freezing; if freezing has occurred, the pen should not be used.36 In-use pens may be stored at room temperature (15-30°C) or under refrigeration (2-8°C) away from direct heat and light for up to 21 days.36
Diabetes Mellitus (Insulin Degludec Therapy)
The dosage of insulin degludec is expressed in units.1 Each mL of insulin degludec injection contains 100 or 200 units of insulin degludec.1
For pediatric patients requiring less than 5 units of insulin degludec each day, use only the insulin degludec U-100 vial.1
Dosage of insulin degludec should be carefully individualized to obtain optimum therapeutic effect based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals.1, 36
Dosage of insulin degludec may be increased every 3-4 days as needed.1
Dosage adjustments may be needed when used with other drugs or with intercurrent conditions (e.g., illness, stress, emotional disturbances), changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), or changes in weight or renal or hepatic function.1, 36
In insulin-naïve patients with type 1 diabetes mellitus, insulin degludec should be administered once daily concomitantly with a prandial, shorter-acting (“bolus”) insulin to provide more optimal postprandial glycemic control.1, 14, 19 When used in a subcutaneous insulin regimen in patients with type 1 diabetes mellitus, an initial insulin degludec dosage usually comprises one-third to one-half of the total daily insulin dosage, with the remainder given preprandially in divided doses as a rapid- or short-acting insulin.1 An initial total daily dosage of insulin (total combined dosages of basal and rapid- or short-acting insulins) of 0.2-0.4 units/kg generally is recommended for insulin-naïve patients with type 1 diabetes mellitus.1
In patients with type 2 diabetes mellitus, insulin degludec can be administered alone or concomitantly with oral antidiabetic agents or with a shorter-acting insulin.1, 14, 19 In insulin-naïve adult and pediatric patients with type 2 diabetes mellitus, the recommended initial dosage of insulin degludec is 10 units once daily, with subsequent dosage adjustments to achieve glycemic goals.1
Transferring from Therapy with Other Insulins
When insulin degludec is substituted for another intermediate- or long-acting insulin in adults with type 1 or type 2 diabetes mellitus, the manufacturer states that the initial dosage of insulin degludec for adults can be identical (on a unit-for-unit basis) to the total daily dosage of the previous longer-acting insulin.1 Close monitoring of blood glucose concentrations is recommended during the transition to insulin degludec from other insulin therapies.1, 19 Additionally, the dosage and timing of concurrent short- or rapid-acting insulins or other concomitant antidiabetic agents may need to be adjusted with the initiation of insulin degludec therapy.1, 19
For pediatric patients 1 year of age and older with type 1 or type 2 diabetes mellitus, the manufacturer recommends initiating insulin degludec at 80% of the previous total daily intermediate- or long-acting insulin dose to reduce the risk of hypoglycemia.1 The dosage of insulin degludec should then be adjusted according to blood glucose determinations to achieve glycemic goals.1
Diabetes Mellitus (Insulin Degludec/Liraglutide Fixed-combination Therapy)
Each mL of the fixed combination of insulin degludec and liraglutide contains 100 units of insulin degludec and 3.6 mg of liraglutide.36
In adults with type 2 diabetes mellitus who are naïve to basal insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist, the recommended initial dosage of the fixed combination of insulin degludec and liraglutide (Xultophy®) is 10 units (10 units of insulin degludec and 0.36 mg of liraglutide) once daily.36
In adults with type 2 diabetes mellitus who are currently receiving basal insulin or a GLP-1 receptor agonist (e.g., liraglutide), such therapy must be discontinued prior to initiation of the fixed combination of insulin degludec and liraglutide.36 The recommended initial dosage of the fixed combination in these patients is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) once daily.36
Dosage of insulin degludec in the fixed combination with liraglutide may be increased or decreased by 2 units (2 units of insulin degludec and 0.072 mg of liraglutide) every 3-4 days as needed.36 The fixed combination of insulin degludec and liraglutide should not be administered more than once daily.36 Adjustments in concomitant oral antidiabetic therapy may be needed.36
The maximum daily dosage of insulin degludec in fixed combination with liraglutide is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).36
Dosage adjustments may be needed when used with other drugs or with intercurrent conditions (e.g., illness, stress, emotional disturbances), changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), or changes in weight or renal or hepatic function.1, 36
As with all insulin preparations, glucose monitoring should be intensified and the dosage of insulin degludec adjusted on an individual basis in patients with hepatic impairment.1, 27 Safety and efficacy of the fixed combination of insulin degludec and liraglutide have not been established in patients with hepatic impairment.36
As with all insulin preparations (including combination preparations), glucose monitoring should be intensified and the dosage of insulin degludec adjusted on an individual basis in patients with renal impairment.1, 26, 36 Experience with the fixed combination of insulin degludec and liraglutide is limited in patients with mild or moderate renal impairment; additional glucose monitoring and dosage adjustment may be needed.36 The fixed combination has not been studied in patients with severe renal impairment.36
In geriatric patients, the initial dosage, dose increments, and maintenance dosage of insulin degludec or the fixed combination of insulin degludec and liraglutide should be conservative in order to avoid hypoglycemia.1, 36
Sharing of Injection Pens, Syringes, or Needles
Injection pens containing insulin degludec or the fixed combination of insulin degludec and liraglutide must never be shared among patients, even if the needle has been changed.1, 36 Needles or syringes used with insulin degludec vials should never be shared among patients.1 Sharing poses a risk for transmission of blood-borne pathogens.1, 36
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Any change in insulin should be made cautiously and only under medical supervision.1, 19, 36 Changes in insulin strength, type, manufacturer, and/or method of administration may predispose patients to hypoglycemia or hyperglycemia.1 The frequency of blood glucose monitoring should be increased when changing a patient's insulin regimen.1, 36 Adjustments to the dosage and timing of concurrent short- or rapid-acting insulin or other glucose-lowering treatments (e.g., oral antidiabetic agents) may be required.1, 19, 36
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; a sudden change in injection site (to an unaffected area) has been reported to result in hypoglycemia.1, 36 Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia.1, 36
Hypoglycemia is the most common adverse effect of insulins, including insulin degludec, and monitoring of blood glucose concentrations is recommended for all patients with diabetes mellitus.1, 36 Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.1, 36 Hypoglycemia can impair the ability to concentrate and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).1, 36 Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, in patients using drugs that block the sympathetic nervous system (e.g., adrenergic blocking agents), and in patients who experience recurrent hypoglycemia.1, 36
The onset of hypoglycemia depends on the action profile of the insulin used and may change when the treatment regimen or timing of dosing of the insulin is changed.1 As with all insulin preparations, the time course of the glucose-lowering effect of insulin degludec or the fixed combination of insulin degludec and liraglutide may vary among different individuals or at different times in the same individual and depends on many conditions (e.g., the area of injection, the injection site blood supply and temperature).1, 36 The risk of hypoglycemia generally increases with the intensity of glycemic control.1, 36 Other factors that may increase a patient's risk of hypoglycemia include changes in meal patterns (e.g., macronutrient content, timing of meals), changes in level of physical activity, or changes to concomitant drug therapy.1 Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.1, 36 Some evidence suggests that insulin degludec may be associated with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, than insulin glargine and insulin detemir.2, 3, 5, 9, 12, 14, 18, 19, 21
Patients and caregivers must be educated to recognize and manage hypoglycemia.1, 36 Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia.1, 36 Increased frequency of blood glucose monitoring is recommended in patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia.1, 36
Hypoglycemia Due to Medication Errors
Confusion between basal insulin preparations and other insulins, particularly rapid-acting insulins, has caused medication errors.1, 36 To avoid such errors, patients should be advised to check the label on all insulin preparations to confirm the correct formulation and strength prior to administration.1, 36 Insulin degludec should not be transferred from the FlexTouch® injection pen into an insulin syrin the insulin syringe will not measure the dose correctly, and may cause an overdose and severe hypoglycemia.1
Administration of more than 50 units of the fixed combination of insulin degludec and liraglutide (which contains 100 units/mL of insulin degludec with 3.6 mg/mL of liraglutide) can result in overdose of the liraglutide component.36 Do not exceed the 1.8 mg maximum recommended dosage of liraglutide when used in fixed combination with insulin degludec; do not use the fixed combination of insulin degludec and liraglutide in combination with another GLP-1 agonist.36
Severe, life-threatening, generalized allergic reactions, including anaphylaxis, angioedema, bronchospasm, hypotension, and shock, may occur with insulin preparations, including insulin degludec.1, 36 If hypersensitivity reactions occur, insulin degludec therapy or the fixed combination of insulin degludec and liraglutide should be discontinued and appropriate treatment initiated; patients should be monitored until the hypersensitivity reaction resolves.1, 36 Insulin degludec and the fixed combination of insulin degludec and liraglutide are contraindicated in patients who have had hypersensitivity reactions to insulin degludec (and/or liraglutide for the fixed combination product) or any of its excipients.1, 36
All insulin preparations, including insulin degludec, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.1, 36 Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death.1, 36 Serum potassium concentrations should be monitored in patients at risk for hypokalemia (e.g., patients receiving potassium-lowering drugs, patients taking drugs with effects sensitive to serum potassium concentrations).1, 36
Fluid Retention and Congestive Heart Failure
Peroxisome proliferator-activated receptor (PPAR)-γ agonists (e.g., thiazolidinediones) can cause dose-related fluid retention, particularly when used in combination with insulin.1, 23, 36 Fluid retention may lead to or exacerbate heart failure.1, 23 Patients treated with insulins, including insulin degludec, and a PPAR-γ agonist should be observed for manifestations of heart failure (e.g., excessive/rapid weight gain, shortness of breath, edema).1, 23, 36 If heart failure develops, it should be managed according to current standards of care and discontinuance or reduction of the dosage of the PPAR-γ agonist must be considered.1, 23, 36
When insulin degludec is used in fixed combination with liraglutide or other drugs, the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) should be considered in addition to those associated with insulin degludec.36
As with all therapeutic proteins, there is a potential for immunogenicity with insulin degludec or the fixed combination of insulin degludec and liraglutide.1, 36 In studies in patients with type 1 and type 2 diabetes mellitus, anti-insulin antibodies were detected in patients receiving insulin degludec therapy, including some patients who had anti-insulin antibodies at baseline.1 In a 52-week trial in insulin-experienced adult patients with type 1 diabetes mellitus, 68.9% of patients who received insulin degludec were positive at baseline for anti-insulin degludec antibodies and 12.3% of patients developed anti-insulin degludec antibodies at least once during the trial.1 In a 52-week trial in insulin-experienced pediatric patients with type 1 diabetes mellitus, 84.1% of patients who received insulin degludec were positive for anti-insulin degludec antibodies at baseline and 5.8% of patients developed anti-insulin degludec antibodies at least once during the trial.1 In a 52-week trial in insulin-naïve adult patients with type 2 diabetes mellitus, 1.7% of patients who received insulin degludec were positive at baseline for anti-insulin degludec antibodies and 6.2% of patients developed anti-insulin degludec antibodies at least once during the trial.1 In these trials, between 96.7% and 99.7% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.1
Antiliraglutide antibodies have been found in patients who received the fixed combination of insulin degludec and liraglutide, but this antibody formation has not been associated with reduced efficacy of the fixed combination.36 However, in rare cases, the presence of such antibodies may necessitate adjustment of the dosage of the fixed combination of insulin degludec and liraglutide in order to correct a tendency to hyperglycemia or hypoglycemia.36
Available data from one unpublished trial and the published literature with insulin degludec use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.1 In a randomized, parallel-group, open-label active-controlled clinical trial in 91 pregnant women with type 1 diabetes mellitus who received insulin degludec once daily and insulin aspart beginning in gestational weeks 8—13 or prior to conception, no clear evidence of maternal or fetal risk associated with insulin degludec use was observed.1 In about two-thirds of infants, insulin degludec was detected in the infant cord blood at levels at the lower level of quantification of the assay.1
In reproduction studies in animals, insulin degludec caused pre- and post-implantation loss and visceral/skeletal abnormalities in the offspring of pregnant rats and rabbits at maternal plasma concentrations 5-10 times higher than those achieved with a subcutaneous human dosage of 0.75 units/kg per day.1, 20 The manufacturer states that these effects are probably secondary to maternal hypoglycemia.1
Data are lacking on the use of the fixed combination of insulin degludec and liraglutide in pregnant women.36 Animal studies suggest that there may be risks to the fetus from exposure to liraglutide during pregnancy.36
Poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.1, 36 Poorly controlled diabetes mellitus also increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.1, 36 Insulin degludec and the fixed combination of insulin degludec and liraglutide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.1, 36
Insulin degludec is distributed into milk in rats; it is not known whether the drug is distributed into human milk.1, 36 Liraglutide also is distributed into milk in lactating rats.36 The effects of insulin degludec on the breast-fed infant or on milk production are not known.1
The benefits of breast-feeding and the importance of insulin degludec alone or with liraglutide to the mother should be considered along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.1, 36
Safety and efficacy of insulin degludec have not been established in pediatric patients younger than 1 year of age.1 For pediatric patients requiring less than 5 units of insulin degludec per day, only the U-100 vial should be used.1 In pediatric patients whose therapy is being transferred from another long- or intermediate-acting insulin to insulin degludec, the drug should be initiated at a reduced dosage to minimize the risk of hypoglycemia.1
Safety and efficacy of insulin degludec in pediatric patients 1 year of age and older are based on a noninferiority clinical study of 12 months' duration in patients 1-17 years of age with type 1 diabetes mellitus, a pharmacokinetic study that included approximately 200 patients 1-17 years of age with type 1 diabetes mellitus, and data from clinical trials conducted in adults with type 2 diabetes mellitus.1, 35 In the noninferiority study, insulin degludec and insulin detemir provided similar glycemic control (as determined by glycosylated hemoglobin [hemoglobin A1c, HbA1c]).1, 35 Adverse effects reported in pediatric patients with type 1 diabetes mellitus who were receiving insulin degludec therapy were similar to those reported in adults.1
Safety and efficacy of the fixed combination of insulin degludec and liraglutide have not been established in pediatric patients.36
In controlled clinical trials of insulin degludec, 77 (7%) patients with type 1 diabetes mellitus were ≥65 years of age and 9 (1%) were ≥75 years of a in patients with type 2 diabetes, 670 (25%) were ≥65 years of age and 80 (3%) were ≥75 years of age.1 In a safety outcomes trial, 1983 (52%) of patients with type 2 diabetes mellitus who received insulin degludec were ≥65 years of age and 381 (10%) were ≥75 years of age.1 No substantial differences in safety and efficacy of insulin degludec or the fixed combination of insulin degludec and liraglutide have been observed in geriatric patients relative to younger patients; however, increased sensitivity of some older patients cannot be ruled out.1, 36 Data indicate that the pharmacokinetic and pharmacodynamic properties of insulin degludec at steady sate are similar in younger adults and geriatric patients; however, greater between-subject variability has been observed among geriatric patients.1
In clinical studies of the fixed combination of insulin degludec and liraglutide in 1881 patients, 375 (19.9%) were ≥65 years of age and 52 (2.8 %) were ≥75 years of age.36 No overall differences in the safety, efficacy, or pharmacokinetics of the fixed combination of insulin degludec and liraglutide were observed between patients ≥65 years of age and older and younger patients.36
Initial dosage, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia.1, 36 Hypoglycemia may be difficult to recognize in geriatric patients.1, 36
In a pharmacokinetic study in patients with or without renal impairment (including some patients with end-stage renal disease) who received a single subcutaneous dose of insulin degludec, there was no clinically relevant difference in the pharmacokinetic parameters in the renally impaired patients compared with healthy individuals.1, 25, 26 Blood glucose concentrations should be monitored closely; adjustment of insulin degludec dosage may be necessary.1
In a pharmacokinetic study in patients with or without hepatic impairment (mild to severe hepatic impairment) who received a single subcutaneous dose of insulin degludec, there was no clinically relevant difference in the pharmacokinetic parameters in the hepatically impaired patients compared with healthy individuals.1, 25, 27 Blood glucose concentrations should be monitored closely; adjustment of insulin degludec dosage may be necessary.1
The most common adverse effects associated with insulin degludec include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.1
Drugs Affecting Glycemic Control
Drugs that May Potentiate Hypoglycemic Effects
Drug interactions are possible with drugs that may potentiate the hypoglycemic effects of insulin degludec (e.g., angiotensin-converting enzyme [ACE] inhibitors,1, 14 angiotensin II receptor antagonists,1 antidiabetic agents,1, 14 dipeptidyl peptidase-4 (DPP-4) inhibitors,1 disopyramide,1 fibrate derivatives,1 fluoxetine,1 glucagon-like peptide-1 (GLP-1) receptor agonists,1, 14 monoamine oxidase [MAO] inhibitors,1, 14 pentoxifylline,1 pramlintide,1 salicylates,1, 14 sodium-glucose cotransporter 2 [SGLT2] inhibitors,1 somatostatin analogs [e.g., octreotide],1 sulfonamide anti-infectives1, 14 ). Dosage reductions and increased frequency of glucose monitoring may be required if insulin degludec or the fixed combination of insulin degludec and liraglutide is used concomitantly with these drugs.1, 36
Drugs that May Antagonize Hypoglycemic Effects
Drug interactions are possible with drugs that may antagonize the hypoglycemic effects of insulin degludec (e.g., atypical antipsychotics [e.g., olanzapine, clozapine],1 corticosteroids,1, 14 danazol,1, 14 diuretics [e.g., thiazides],1, 14 estrogens or progestins [e.g., oral contraceptives],1, 14 glucagon,1 isoniazid,1 niacin,1 phenothiazines,1 protease inhibitors,1 somatropin,1 sympathomimetic agents [e.g., albuterol, epinephrine, terbutaline],1, 14 thyroid hormones)1, 14 . Insulin degludec dosage increases and increased frequency of glucose monitoring may be required if insulin degludec or the fixed combination of insulin degludec and liraglutide is used concomitantly with these drugs.1, 36
Drugs With a Variable Effect on Glycemic Control
Drug interactions are possible with drugs that may have variable effects on glycemic control (e.g., alcohol,1β-adrenergic blocking agents (β-blockers),1 clonidine,1 lithium salts,1 pentamidine).1 Dosage adjustments of insulin degludec or the fixed combination of insulin degludec and liraglutide and increased frequency of glucose monitoring may be required if used concomitantly with these drugs.1, 36
Sympatholytic agents (e.g., β-blockers, clonidine, guanethidine, reserpine) may decrease or eliminate the signs and symptoms of hypoglycemia in patients receiving insulin degludec or the fixed combination of insulin degludec and liraglutide concomitantly with these drugs .1, 14 Increased frequency of glucose monitoring may be required if insulin degludec or the fixed combination of insulin degludec and liraglutide is used concomitantly with these drugs.1, 36
Peroxisome Proliferator-activated Receptor- Agonists
Peroxisome proliferator-activated receptor (PPAR)-γ agonists (e.g., thiazolidinediones) can cause dose related fluid retention, particularly when used in combination with insulin.1, 23 Fluid retention may lead to or exacerbate heart failure.1, 23 Patients treated with insulin, including insulin degludec, and a PPAR-γ agonist should be observed for manifestations of heart failure (e.g., excessive/rapid weight gain, shortness of breath, edema).1, 23
No clinically relevant interaction suggested by in vitro binding studies with other protein-bound drugs.1
Insulin degludec is a biosynthetic (rDNA origin), long-acting basal insulin human analog that is prepared using a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.1 Insulin degludec differs structurally from insulin human by the deletion of threonine at position 30 on the B chain and by the acylation of lysine at position 29 on the B chain with hexadecandioic acid, a 16-carbon fatty acid, via a glutamic acid spacer.1, 14, 19, 22
Insulin degludec has pharmacologic effects comparable to those of insulin human.21 The prolonged duration of action of insulin degludec is dependent in part on slow systemic absorption, predominantly due to the formation of a depot of soluble multihexamer chains after subcutaneous injection and to a lesser extent due to binding of insulin degludec to circulating albumin.1, 14, 15, 19, 21 The fatty acid side chain modification of insulin degludec favors the formation of stable dihexamers while in solution at a neutral pH in the presence of phenol and zinc.14, 15, 18, 19, 21, 25 After subcutaneous injection, these dihexamers assemble into long multihexamers; the large molecular weight of these multihexamers slows absorption, which creates a subcutaneous depot of insulin degludec from which monomers slowly dissociate in circulation.18, 25
The 100-units/mL and 200-units/mL formulations of insulin degludec are pharmacodynamically and pharmacokinetically bioequivalent and have shown similar effects on glycemic control at equivalent dosages in clinical trials.1, 6, 14 Total and maximum insulin degludec exposures at steady state are comparable between the U-100 and U-200 insulin degludec products when administered at the same units/kg dose.1 The median onset of appearance of insulin degludec is approximately 1 hour following the first subcutaneous dose; maximum concentrations are attained at a median of 9 hours.1 Total insulin degludec concentration increases in a dose proportional manner over a subcutaneous dosage range of 0.4—0.8 units/kg.1 Steady state concentrations are achieved after 3—4 days of insulin degludec administration.1 Due to the prolonged pharmacodynamics of insulin degludec, under steady state conditions the overlapping effect of daily injections results in less variability in glucose-lowering effect.19 Total exposure (in terms of AUC) and glucose-lowering effect of insulin degludec have been shown to be more evenly distributed than other basal insulins across a 24-hour dosing interval (i.e., peakless) in patients with type 1 or type 2 diabetes mellitus.19, 21, 25 Insulin degludec has a longer duration of action than insulin detemir and insulin glargine, and insulin degludec therapy is associated with less pharmacodynamic variability than other basal insulins.3, 14, 18, 25 Insulin degludec has been associated with a fourfold lower within-patient day-to-day variability with regard to total glucose lowering effect compared to insulin glargine.21, 33 Insulin degludec has a long, flat, stable glucose lowering-profile, with a duration of action exceeding 42 hours and a terminal elimination half-life of approximately 25 hours.1, 14, 18, 19 Insulin degludec metabolism is similar to that of insulin human; all metabolites are inactive.1 Insulin degludec is highly (>99%) protein bound to serum albumin.1 In pediatric patients, body weight is a significant factor affecting the clearance of insulin degludec; after adjusting for body weight, total exposure of insulin degludec at steady state is independent of age.1 The pharmacokinetics of insulin degludec are similar in younger and geriatric patients, although there is greater between-subject variability in geriatric patients.1 Gender, race, and ethnicity have no impact on the pharmacokinetic properties of insulin degludec.1 In patients with type 1 and type 2 diabetes mellitus, a trend for a decrease in the glucose-lowering effect of insulin degludec with increasing body mass index (BMI) has been observed.1 Mild to severe renal impairment is associated with an increase in AUC and peak exposure of insulin degludec, although no systematic trend has been noted for this increase in exposure across renal impairment subgroups.1 In patients with end-stage renal disease, exposure is similar to patients with normal renal function; hemodialysis does not affect insulin degludec clearance.1 There are no differences in the pharmacokinetics of insulin degludec in patients with hepatic impairment.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 100 units/mL | Tresiba® (available as vials and FlexTouch® prefilled pens) | |
200 units/mL | Tresiba® (available as FlexTouch® prefilled pens) | Novo Nordisk |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 100 units/mL with Liraglutide 3.6 mg/mL | Xultophy® (available as prefilled injection pens) | Novo Nordisk |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions November 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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