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As demonstrated in the BEGIN clinical trial program

Tresiba® met A1C efficacy noninferiority endpoints in 7 out of 7 trials vs insulin glargine U-1001

ADULTS WITH T2D

ADULTS WITH T1D

Mean A1C Chart

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 8.2%
End of trial: 7.0%
Reduction: –1.15%

Baseline: 8.2%
End of trial: 6.9%
Reduction: –1.22%

Insulin glargine U-100 + insulin aspart

Baseline: 7.7%
End of trial: 7.3%
Reduction: –0.34%

Tresiba®: A1C reduction chart in Type 2 Diabetes patients
primary_msg

ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 8.2%
End of trial: 7.0%
Reduction: –1.15%


ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 8.2%
End of trial: 6.9%
Reduction: –1.22%


ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + insulin aspart

Baseline: 7.7%
End of trial: 7.3%
Reduction: –0.34%

  • At week 52, the difference in A1C reduction from baseline for Tresiba® and insulin glargine U-1001:
    • Study D, 0.09% (95% CI, –0.04%; 0.22%)
    • Study A, –0.01% (95% CI, –0.14%; 0.11%)
  • At week 26, the difference in A1C reduction from baseline for Tresiba® U-200 and insulin glargine U-1001:
    • Study E, 0.04% (95% CI, –0.11%; 0.19%)
  • A1C results were similar between Tresiba® and insulin glargine U-100 in the other 4 clinical trials1
  • The prespecified noninferiority margin (0.4%) was met in all 7 clinical trials1


FPG reductions with Tresiba®1


ADULTS WITH T2D

ADULTS WITH T1D

FPG Chart

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 174 mg/dL
End of trial: 115 mg/dL
Reduction: –60.2 mg/dL

Baseline: 174 mg/dL
End of trial: 113 mg/dL
Reduction: –63.5 mg/dL

Insulin glargine U-100 + insulin aspart

Baseline: 174 mg/dL
End of trial: 149 mg/dL
Reduction: –21.6 mg/dL

Tresiba®: A1C reduction chart in Type 2 Diabetes patients

ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 174 mg/dL
End of trial: 115 mg/dL
Reduction: –60.2 mg/dL


ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 174 mg/dL
End of trial: 113 mg/dL
Reduction: –63.5 mg/dL


ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + insulin aspart

Baseline: 174 mg/dL
End of trial: 149 mg/dL
Reduction: –21.6 mg/dL


  • FPG results were similar between Tresiba® and insulin glargine U-100 in the other 4 clinical trials

Additional efficacy endpoint in Studies D, E, and A: FPG reduction from baseline through week 26 (Study E) or week 52 (Studies D and A)2-4

secondary_msg

Find out what endocrinologist Dr Steven Edelman looks for when prescribing a basal insulin
In the BEGIN clinical trials

Hypoglycemia incidence rates were comparable among Tresiba® and other basal insulins1

Percentage of patients with type 1 diabetes who experienced at least 1 episode of severe Novo Nordisk–defined hypoglycemiaa,b

10.4% to 12.7% for severe hypoglycemiaa
93.0% to 99.4% for Novo Nordisk–defined hypoglycemiab (basal-bolus regimen)

Percentage of patients with type 2 diabetes who experienced at least 1 episode of severe Novo Nordisk–defined hypoglycemiaa,b

0% to 4.5% for severe hypoglycemiaa
28.5% to 80.9% for Novo Nordisk–defined hypoglycemiab (OADs and/or basal bolus)

aSevere hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
bNovo Nordisk–defined hypoglycemia: a severe hypoglycemia event or an event where laboratory or self-measured glucose calibrated to plasma was <56 mg/dL or where whole blood glucose was <50 mg/dL (ie, with or without the presence of hypoglycemic symptoms).


Study designs
Study D
Insulin-naïve adults with type 2 diabetes1,2

Patients randomized: Tresiba® (n=773); insulin glargine U-100 (n=257).

Study design: 52-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-100 and once-daily insulin glargine U-100, both with metformin with or without a DPP-4 inhibitor. Basal insulin was titrated weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast self-measured blood glucose (SMBG) values (mean of 3 consecutive days).

Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.

Other efficacy assessments: Change from baseline in FPG, SMBG, and A1C <7% responders.

Mean end-of-trial basal insulin doses: Tresiba®, 56 units; insulin glargine U-100, 58 units.

Study E
Insulin-naïve adults with type 2 diabetes1,3

Patients randomized: Tresiba® (n=228); insulin glargine U-100 (n=229).

Study design: 26-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-200 and once-daily insulin glargine U-100, both with metformin with or without a DPP-4 inhibitor. Basal insulin was titrated weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast SMBG values (mean of 3 consecutive days).

Primary endpoint: Change in A1C from baseline after 26 weeks of treatment.

Secondary confirmatory endpoints: Number of treatment-emergent confirmed hypoglycemic episodes, change from baseline in FPG, within-subject variability as measured by coefficient of variation, and frequency of participants achieving A1C <7% without confirmed hypoglycemic episodes.

Mean end-of-trial basal insulin doses: Tresiba®, 59 units; insulin glargine U-100, 62 units.

Study A
Adults with type 1 diabetes1,4

Patients randomized: Tresiba® (n=472); insulin glargine U-100 (n=157).

Study design: 52-week, randomized, controlled, open-label, multinational, parallel design, treat-to-target, noninferiority trial comparing the efficacy and safety of once-daily Tresiba® U-100 and once-daily insulin glargine U-100. Insulin aspart was administered before each meal in both treatment arms. Basal insulin was titrated once weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast SMBG values (mean of 3 consecutive days). Bolus insulin was titrated to preprandial and bedtime SMBG concentrations of 70 to 90 mg/dL.

Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.

Secondary endpoints: FPG, SMBG, hypoglycemia, bodyweight, and lipids.

Mean end-of-trial basal and bolus insulin doses: Tresiba® arm: Tresiba®, 29 units; insulin aspart, 32 units; insulin glargine U-100 arm: insulin glargine U-100, 31 units; insulin aspart, 35 units.

View the mechanism of protraction video to see how Tresiba® works

Selected Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. 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. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening

Indications and Usage

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. 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. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Prescribing Information

 

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  2. Zinman B, Philis-Tsimikas A, Cariou B, et al. Diabetes Care. 2012;35(12):2464-2471.
  3. Gough SCL, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Diabetes Care. 2013;36(9):2536-2542.
  4. Heller S, Buse J, Fisher M, et al. Lancet. 2012;379(9825):1489-1497.